Olumiant Drug Information
Generic name: BARICITINIB
Janus Kinase Inhibitor [EPC]
Uses of Olumiant
Rheumatoid Arthritis
OLUMIANT ® (baricitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
Coronavirus Disease 2019 (COVID-19)
OLUMIANT is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Alopecia Areata
OLUMIANT is indicated for the treatment of adult patients with severe alopecia areata. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Dosage & Administration of Olumiant
| ≥500 cells/μL | |
| Interrupt OLUMIANT until ALC ≥500 cells/μL | |
| ≥1000 cells/μL | |
| Interrupt OLUMIANT until ANC ≥1000 cells/μL | |
| ≥8 g/dL | |
| Interrupt OLUMIANT until hemoglobin ≥8 g/dL |
Side Effects of Olumiant
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice. Adverse Reactions in Patients with Rheumatoid Arthritis The safety of OLUMIANT was evaluated in six randomized double-blind placebo-controlled studies (three Phase 2, three Phase 3) and a long-term extension study in patients with moderately to severely active RA. Patients were randomized to placebo (1070 patients), OLUMIANT 2 mg (479 patients), or baricitinib 4 mg (997 patients). Patients could be switched to baricitinib 4 mg from placebo or OLUMIANT 2 mg from as early as Week 12 depending on the study design. All patients initially randomized to placebo were switched to baricitinib 4 mg by Week 24. During the 16-week treatment period, adverse events leading to discontinuation of treatment were reported by 35 patients (11.4 per 100 patient-years) treated with placebo, 17 patients (12.1 per 100 patient-years) with OLUMIANT 2 mg, and 40 patients (13.4 per 100 patient-years) treated with baricitinib 4 mg.
During 0 to 52-week exposure, adverse events leading to discontinuation of treatment were reported by 31 patients (9.2 per 100 patient-years) with OLUMIANT 2 mg, and 92 patients (10.2 per 100 patient-years) treated with baricitinib 4 mg. Overall Infections – During the 16-week treatment period, infections were reported by 253 patients (82.1 per 100 patient-years) treated with placebo, 139 patients (99.1 per 100 patient-years) treated with OLUMIANT 2 mg, and 298 patients (100.1 per 100 patient-years) treated with baricitinib 4 mg. During 0 to 52-week exposure, infections were reported by 200 patients (59.6 per 100 patients-years) treated with OLUMIANT 2 mg, and 500 patients (55.3 per 100 patient-years) treated with baricitinib 4 mg.
In the 0 to 52-week exposure population, the most commonly reported infections with OLUMIANT were viral upper respiratory tract infection, upper respiratory tract infection, urinary tract infection, and bronchitis. Serious Infections – During the 16-week treatment period, serious infections were reported in 13 patients (4.2 per 100 patient-years) treated with placebo, 5 patients (3.6 per 100 patient-years) treated with OLUMIANT 2 mg, and 11 patients (3.7 per 100 patient-years) treated with baricitinib 4 mg. During 0 to 52-week exposure, serious infections were reported in 14 patients (4.2 per 100 patient-years) treated with OLUMIANT 2 mg and 32 patients (3.5 per 100 patient-years) treated with baricitinib 4 mg.
In the 0 to 52-week exposure population, the most commonly reported serious infections with OLUMIANT were pneumonia, herpes zoster, and urinary tract infection . Tuberculosis – During the 16-week treatment period, no events of tuberculosis were reported. During 0 to 52-week exposure, events of tuberculosis were reported in 0 patients treated with OLUMIANT 2 mg and 1 patient (0.1 per 100 patient-years) treated with baricitinib 4 mg . Cases of disseminated tuberculosis were also reported. Opportunistic Infections (excluding tuberculosis) – During the 16-week treatment period, opportunistic infections were reported in 2 patients (0.6 per 100 patient-years) treated with placebo, 0 patients treated with OLUMIANT 2 mg and 2 patients (0.7 per 100 patient-years) treated with baricitinib 4 mg.
During 0 to 52-week exposure, opportunistic infections were reported in 1 patient (0.3 per 100 patient-years) treated with OLUMIANT 2 mg and 5 patients (0.6 per 100 patient-years) treated with baricitinib 4 mg . Malignancies During the 16-week treatment period, malignancies excluding non-melanoma skin cancers (NMSC) were reported in 0 patients treated with placebo, 1 patient (0.7 per 100 patient-years) treated with OLUMIANT 2 mg, and 1 patient (0.3 per 100 patient-years) treated with baricitinib 4 mg. During the 0 to 52-week treatment period, malignancies excluding NMSC were reported in 2 patients (0.6 per 100 patient-years) treated with OLUMIANT 2 mg and 6 patients (0.7 per 100 patient-years) treated with baricitinib 4 mg . Thrombosis Venous Thrombosis – During the 16-week treatment period, venous thromboses (deep vein thrombosis or pulmonary embolism) were reported in 0 patients treated with placebo, 0 patients treated with OLUMIANT 2 mg, and 5 patients (1.7 per 100 patient-years) treated with baricitinib 4 mg. During the 0 to 52-week treatment period, venous thromboses were reported in 2 patients (0.6 per 100 patient-years) treated with OLUMIANT 2 mg and 7 patients (0.8 per 100 patient-years) treated with baricitinib 4 mg.
Arterial Thrombosis – During the 16-week treatment period, arterial thromboses were reported in 1 patient treated with placebo (0.3 per 100 patient-years), 2 patients (1.4 per 100 patient-years) treated with OLUMIANT 2 mg, and 2 patients (0.7 per 100 patient-years) treated with baricitinib 4 mg. During the 0 to 52-week treatment period, arterial thromboses were reported in 3 patients (0.9 per 100 patient-years) treated with OLUMIANT 2 mg and 3 patients (0.3 per 100 patient-years) treated with baricitinib 4 mg. Laboratory Abnormalities Neutropenia – During the 16-week treatment period, neutrophil counts below 1000 cells/mm 3 occurred in 0% of patients treated with placebo, 0.6% of patients treated with OLUMIANT 2 mg, and 0.3% of patients treated with baricitinib 4 mg.
There were no neutrophil counts below 500 cells/mm 3 observed in any treatment group . Platelet Elevations – During the 16-week treatment period, increases in platelet counts above 600,000 cells/mm 3 occurred in 1.1% of patients treated with placebo, 1.1% of patients treated with OLUMIANT 2 mg, and 2.0% of patients treated with baricitinib 4 mg. Mean platelet count increased by 3000 cells/mm 3 at 16 weeks in patients treated with placebo, by 15,000 cells/mm 3 at 16 weeks in patients treated with OLUMIANT 2 mg and by 23,000 cells/mm 3 in patients treated with baricitinib 4 mg. Liver Enzyme Elevations – Events of increases in liver enzymes ≥3 times the ULN were observed in patients treated with OLUMIANT . During the 16-week treatment period, ALT elevations ≥3 times the ULN occurred in 1.0% of patients treated with placebo, 1.7% of patients treated with OLUMIANT 2 mg, and 1.4% of patients treated with baricitinib 4 mg.
During the 16-week treatment period, AST elevations ≥ 3 times the ULN occurred in 0.8% of patients treated with placebo, 1.3% of patients treated with OLUMIANT 2 mg, and 0.8% of patients treated with baricitinib 4 mg. In a phase 3 study of DMARD naive patients, during the 24-week treatment period, ALT and AST elevations ≥3 times the ULN occurred in 1.9% and 0% of patients treated with methotrexate monotherapy, 1.9% and 1.3% of patients treated with baricitinib 4 mg monotherapy, and 4.7% and 1.9% of patients treated with baricitinib 4 mg plus methotrexate. Lipid Elevations – In controlled clinical trials, OLUMIANT treatment was associated with dose-related increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol.
Elevations were observed at 12 weeks and remained stable thereafter. During the 12-week treatment period, changes in lipid parameters are summarized below: Mean LDL cholesterol increased by 8 mg/dL in patients treated with OLUMIANT 2 mg and by 14 mg/dL in patients treated with baricitinib 4 mg. Mean HDL cholesterol increased by 7 mg/dL in patients treated with OLUMIANT 2 mg and by 9 mg/dL in patients treated with baricitinib 4 mg.
The mean LDL/HDL ratio remained stable. Mean triglycerides increased by 7 mg/dL in patients treated with OLUMIANT 2 mg and by 15 mg/dL in patients treated with baricitinib 4 mg.. Creatine Phosphokinase (CPK) – OLUMIANT treatment was associated with increases in CPK within one week of starting OLUMIANT and plateauing after 8 to 12 weeks. At 16 weeks, the mean change in CPK for OLUMIANT 2 mg and baricitinib 4 mg was 37 IU/L and 52 IU/L, respectively.
Creatinine – In controlled clinical trials, dose-related increases in serum creatinine were observed with OLUMIANT treatment. At 52 weeks, the mean increase in serum creatinine was less than 0.1 mg/dL with baricitinib 4 mg. The clinical significance of the observed serum creatinine increases is unknown.
Other Adverse Reactions Other adverse reactions are summarized in Table 8. Table 8: Adverse Reactions Occurring in Greater Than or Equal to 1% of OLUMIANT 2 mg and Baricitinib 4 mg Treated Patients in Placebo-Controlled Trials for Rheumatoid Arthritis a Includes acute sinusitis, acute tonsillitis, chronic tonsillitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinobronchitis, sinusitis, tonsillitis, tracheitis, and upper respiratory tract infection. b Includes eczema herpeticum, genital herpes, herpes simplex, ophthalmic herpes simplex, and oral herpes. Events Weeks 0-16 Placebo OLUMIANT 2 mg Baricitinib 4 mg n=1070 (%) n=479 (%) n=997 (%) Upper respiratory tract infections a 11.7 16.3
Nausea 1.6 2.7 2.8 Herpes simplex b 0.7 0.8 1.8 Herpes zoster
0.4 1.0
Additional adverse drug reactions occurring in fewer than 1% of patients: acne.
Adverse Reactions in Patients with COVID-19 The safety of OLUMIANT was evaluated in two randomized, double-blind, placebo-controlled clinical trials of hospitalized adults with COVID-19 for up to 29 days, in which 1307 patients received at least one dose of OLUMIANT 4 mg once daily, and 1310 patients received placebo, for up to 14 days or until hospital discharge, whichever occurred first. In these studies, prophylaxis for venous thromboembolic event (VTEs) was recommended or required for all patients unless a major contraindication was noted. Overall, the safety profile observed in patients with COVID-19 treated with OLUMIANT was consistent with the safety profile in patients with rheumatoid arthritis.
Overall Infections – During the first 29 days of the randomized clinical trials, infections were reported in 194 patients (14.8%) treated with OLUMIANT 4 mg and by 219 patients (16.7%) treated with placebo. The most commonly reported infection with OLUMIANT was pneumonia (3.1%). Serious Infections – During the first 29 days of the randomized clinical trials, serious infections were reported in 98 patients (7.5%) treated with OLUMIANT 4 mg and 120 patients (9.2%) treated with placebo. The most commonly reported serious infections with OLUMIANT were COVID-19 pneumonia (2.1%) and septic shock (2.1%). Opportunistic Infections – During the first 29 days of the randomized clinical trials, opportunistic infections were reported in 12 patients (0.9%) treated with OLUMIANT 4 mg and 14 patients (1.1%) treated with placebo.
Tuberculosis was reported in 1 patient (0.1%) treated with OLUMIANT 4 mg and 0 patients treated with placebo. Venous Thrombosis Events - During the first 29 days of the randomized clinical trials, pulmonary embolism was reported in 20 patients (1.5%) treated with OLUMIANT 4 mg and 11 patients (0.8%) treated with placebo. Deep vein thrombosis was reported in 20 patients (1.5%) treated with OLUMIANT 4 mg and 18 patients (1.4%) treated with placebo.
Adverse drug reactions in greater than or equal to 1% of patients in trials for COVID-19 are summarized in Table 9. Table 9: Adverse Reactions That Occurred in Greater Than or Equal to 1% of Patients Treated with OLUMIANT 4 mg During the First 29 Days in Placebo-Controlled Trials for COVID-19 a As assessed by measured values within the clinical trial database. Frequencies are based on shifts from pre-treatment to post-treatment (with number at risk as the denominator), except for ALT and AST for which frequencies are based on observed elevation during treatment. b Creatine phosphokinase frequencies presented in the table were available for a single trial (COVID II) in patients with COVID-19 and do not represent integrated data. Placebo N = 1310 n (%) OLUMIANT 4 mg N = 1307 n (%) ALT ≥3 x ULN a 201 230 AST ≥3 x ULN a 117 149 Thrombocytosis >600,000 cells/mm 3a 34 59 Creatine phosphokinase (CPK) >5 x ULN a, b 38 36 Neutropenia <1000 cells/mm 3a 22 26 Deep vein thrombosis 18 20 Pulmonary embolism 11 20 Urinary tract infection 13 19 Adverse Reactions in Patients with Alopecia Areata The safety of OLUMIANT was evaluated in two placebo-controlled trials in patients with severe alopecia areata.
Patients were randomized to placebo (371 patients), OLUMIANT 2 mg (365 patients), or OLUMIANT 4 mg (540 patients). Of these, a total of 845 patients were treated with OLUMIANT for at least 1 year. Table 10 summarizes adverse reactions that occurred at a frequency of at least 1% in patients treated with OLUMIANT 2 mg once daily or OLUMIANT 4 mg once daily and more frequently than in patients treated with placebo during the 36-week placebo-controlled period of the alopecia areata clinical trials. Table 10: Adverse Reactions That Occurred in ≥1% of Patients Treated with OLUMIANT 2 mg or OLUMIANT 4 mg in Alopecia Areata Trials a %-study size adjusted percentages. b URTI includes: acute sinusitis, influenza, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, viral upper respiratory tract infection, viral sinusitis, viral pharyngitis, respiratory tract infection viral, rhinovirus infection and adenoiditis c Acne includes: acne and dermatitis acneiform. d Hyperlipidemia includes: hyperlipidaemia, hypercholesterolaemia, hypertriglyceridaemia, dyslipidaemia, lipids increased, low density lipoprotein increased, blood cholesterol increased, and blood triglycerides increased. e UTI includes: cystitis, urinary tract infection, white blood cells urine positive, urinary tract infection bacterial, and pyelonephritis. f Liver enzyme elevations includes: transaminases increased, aspartate aminotransferase increased, alanine aminotransferase increased, hepatic enzyme increased, gamma-glutamyl transferase increased, and hepatic function abnormal. g Folliculitis was most commonly localized in the scalp region associated with hair regrowth h LRTI includes: bronchitis, bronchiolitis, lower respiratory tract infection, pneumonia, COVID-19 pneumonia, and respiratory tract infection. i Genital Candida infections includes: vulvovaginal candidiasis, vulvovaginal mycotic infection, and genital infection fungal. j Neutropenia includes: neutropenia and neutrophil count decreased. k Abdominal pain includes: abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal discomfort.
Adverse Reaction Weeks 0-36 Placebo OLUMIANT 2 mg OLUMIANT 4 mg N=371 (%) a N=365 (%) a N=540 (%) a Upper respiratory tract infections b (URTI) 19.9 18.4
Headache 5.4 5.5 6.6 Acne c 2.2 5.8 5.9 Hyperlipidemia d 3.0
3.6
Blood creatine phosphokinase increased 1.3 0.8 4.3 Urinary tract infections (UTI) e
2.2 3.8
Liver enzyme elevations f 2.4 1.1 3.0 Folliculitis g 0.8 1.4 2.2
Fatigue 1.1 0.8
Genital Candida infections i 0.3 2.2 1.3 Anemia 0.3 0.3 1.3 Neutropenia
j 0.8 0.3
Abdominal pain k 2.2 3.8 0.9 Herpes zoster 0.5 1.4 0.9 Weight
increased 0.3 1.6
In patients treated with any dose of baricitinib, adverse reactions that occurred
in fewer than 1% of patients include arterial thrombosis, B cell lymphoma, lymphopenia, and fungal skin infections. Additional adverse reactions observed after Week 52: venous thromboembolic events (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE), and malignancy including non-melanoma skin cancer. Overall, the adverse reactions observed in patients with alopecia areata treated with OLUMIANT were consistent with the adverse reactions in patients with rheumatoid arthritis.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of OLUMIANT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Immune System Disorders : Drug hypersensitivity (events such as rash, urticaria, and angioedema have been reported) .
Warnings & Cautions for Olumiant
Serious Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive
fungal, viral, or other opportunistic pathogens have been reported in patients with rheumatoid arthritis receiving OLUMIANT. The most common serious infections reported with OLUMIANT included pneumonia, herpes zoster, and urinary tract infection . Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with OLUMIANT. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of OLUMIANT in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating OLUMIANT in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or an opportunistic infection who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
In patients with rheumatoid arthritis or alopecia areata, closely monitor for the development of signs and symptoms of infection during and after treatment with OLUMIANT. Interrupt OLUMIANT in patients with rheumatoid arthritis or alopecia areata, if the patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with OLUMIANT should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and OLUMIANT should be interrupted if the patient is not responding to therapy. Do not resume OLUMIANT until the infection is controlled.
In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with OLUMIANT. There is limited information regarding the use of OLUMIANT in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with OLUMIANT in COVID-19 patients with other concurrent infections should be considered. Tuberculosis Evaluate patients for active infection prior to administration of OLUMIANT. OLUMIANT should not be given to patients with active TB. Test patients with rheumatoid arthritis or alopecia areata for latent tuberculosis.
Patients with rheumatoid arthritis or alopecia areata and latent tuberculosis (TB) should be treated with standard antimycobacterial therapy before initiating OLUMIANT. Consider anti-TB therapy prior to initiation of OLUMIANT in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient. During OLUMIANT use, monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with OLUMIANT. If a patient develops herpes zoster, interrupt OLUMIANT treatment until the episode resolves. The impact of OLUMIANT on chronic viral hepatitis reactivation is unknown. Patients with evidence of active hepatitis B or C infection were excluded from clinical trials.
In clinical trials in patients with rheumatoid arthritis or alopecia areata, patients who were positive for hepatitis C antibody but negative for hepatitis C virus RNA were permitted to enroll. Patients with positive hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, were permitted to enroll; such patients should be monitored for expression of hepatitis B virus (HBV) DNA. Should HBV DNA be detected, consult with a hepatologist. Perform screening for viral hepatitis in accordance with clinical guidelines before starting therapy with OLUMIANT.
Mortality
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OLUMIANT.
Malignancy and Lymphoproliferative Disorders Malignancies were observed in clinical studies of
OLUMIANT . In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
In this study, current or past smokers had an additional increased risk of overall malignancies. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OLUMIANT, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers. Non-melanoma skin cancers Non-melanoma skin cancers (NMSCs) have been reported in patients treated with OLUMIANT. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Major Adverse Cardiovascular Events
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OLUMIANT, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors.
Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OLUMIANT in patients that have experienced a myocardial infarction or stroke.
Thrombosis Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has
been observed at an increased incidence in patients treated with OLUMIANT compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with OLUMIANT. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events.
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers. If clinical features of DVT/PE or arterial thrombosis occur, patients should discontinue OLUMIANT and be evaluated promptly and treated appropriately. Avoid OLUMIANT in patients that may be at increased risk of thrombosis.
Hypersensitivity Reactions such as angioedema, urticaria, and rash that may reflect drug
hypersensitivity have been observed in patients receiving OLUMIANT, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue OLUMIANT while evaluating the potential causes of the reaction .
Gastrointestinal Perforations Gastrointestinal perforations have been reported in clinical studies with
OLUMIANT. Monitor OLUMIANT-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Evaluate promptly patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation.
Laboratory Abnormalities Neutropenia – Treatment with
OLUMIANT was associated with an increased incidence of neutropenia (ANC less than 1000 cells/mm 3 ) compared to placebo. In patients with rheumatoid arthritis or alopecia areata, avoid initiation or interrupt OLUMIANT treatment in patients with an ANC less than 1000 cells/mm 3. In patients with COVID-19, there is limited information regarding use of OLUMIANT in patients with ANC less than 1000 cells/mm 3. Avoid initiation or interrupt OLUMIANT treatment in patients with COVID-19 and an ANC less than 500 cells/mm 3. Evaluate at baseline and thereafter according to routine patient management. Adjust dosing based on ANC . Lymphopenia – ALC less than 500 cells/mm 3 were reported in OLUMIANT clinical trials.
Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with OLUMIANT, but not placebo. In patients with rheumatoid arthritis or alopecia areata, avoid initiation or interrupt OLUMIANT treatment in patients with an ALC less than 500 cells/mm 3. In patients with COVID-19, there is limited information regarding use of OLUMIANT in patients with ALC less than 200 cells/mm 3. Avoid initiation or interrupt OLUMIANT treatment in patients with COVID-19 and an ALC less than 200 cells/mm 3. Evaluate at baseline and thereafter according to routine patient management. Adjust dosing based on ALC . Anemia – Decreases in hemoglobin levels to less than 8 g/dL were reported in OLUMIANT clinical trials.
In patients with rheumatoid arthritis or alopecia areata, avoid initiation or interrupt OLUMIANT treatment in patients with hemoglobin less than 8 g/dL. Evaluate at baseline and thereafter according to routine patient management. Adjust dosing based on hemoglobin levels . In patients with COVID-19, there is limited information regarding use of OLUMIANT in patients with hemoglobin less than 8 g/dL. Liver Enzyme Elevations – Treatment with OLUMIANT was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5 times the upper limit of normal (ULN) and increases of AST ≥10 times the ULN were observed in patients in OLUMIANT clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt OLUMIANT until this diagnosis is excluded . Lipid Elevations – Treatment with OLUMIANT was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol.
Assessment of lipid parameters should be performed approximately 12 weeks following OLUMIANT initiation in patients with rheumatoid arthritis or alopecia areata . Manage patients according to clinical guidelines for the management of hyperlipidemia.
Vaccinations
Avoid use of live vaccines with OLUMIANT. Update immunizations in patients with rheumatoid arthritis or alopecia areata prior to initiating OLUMIANT therapy in agreement with current immunization guidelines.
Drug Interactions with Olumiant
Strong
OAT3 Inhibitors Baricitinib exposure is increased when OLUMIANT is co-administered with strong OAT3 inhibitors (such as probenecid), hence the dosage of baricitinib should be reduced by half the recommended dose .
Other
JAK Inhibitors or Biologic DMARDs OLUMIANT has not been studied in combination with other JAK inhibitors or with biologic DMARDs .
Pregnancy Safety for Olumiant
Pregnancy Risk Summary Based on the findings from animal reproduction studies, OLUMIANT may cause fetal harm during pregnancy. Available data from clinical trials and postmarketing case reports with OLUMIANT exposure in pregnancy are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no human data on chronic baricitinib exposure throughout pregnancy.
There are risks to the mother and the fetus associated with rheumatoid arthritis in pregnancy (see Clinical Considerations). Consider the risks and benefits with chronic use of OLUMIANT during pregnancy. In animal embryo-fetal development studies, oral baricitinib administration to pregnant rats and rabbits at exposures equal to and greater than approximately 11 and 46 times the maximum recommended human dose (MRHD) of 4 mg/day, respectively, resulted in reduced fetal body weights, increased embryolethality (rabbits only), and dose-related increases in skeletal malformations. No developmental toxicity was observed in pregnant rats and rabbits treated with oral baricitinib during organogenesis at approximately 2 and 7 times the exposure at the MRHD, respectively.
In a pre- and post-natal development study in pregnant female rats, oral baricitinib administration at exposures approximately 24 times the MRHD resulted in reduction in pup viability (increased incidence of stillborn pups and early neonatal deaths), decreased fetal birth weight, reduced fetal body weight gain, decreased cytotoxic T cells on post-natal day (PND) 35 with evidence of recovery by PND 65, and developmental delays that might be attributable to decreased body weight gain. No developmental toxicity was observed at an exposure approximately 5 times the exposure at the MRHD (see Data). The background risks of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Report pregnancies to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.
Data Animal Data In an embryofetal development study in pregnant rats, dosed orally during the period of organogenesis from gestation days 6 to 17, baricitinib was teratogenic (skeletal malformations that consisted of bent limb bones and rib anomalies) at exposures equal to or greater than approximately 11 times the MRHD (on an AUC basis at maternal oral doses of 10 mg/kg/day and higher). No developmental toxicity was observed in rats at an exposure approximately 2 times the MRHD (on an AUC basis at a maternal oral dose of 2 mg/kg/day). In an embryofetal development study in pregnant rabbits, dosed orally during the period of organogenesis from gestation days 7 to 20, embryolethality, decreased fetal body weights, and skeletal malformations (rib anomalies) were observed in the presence of maternal toxicity at an exposure approximately 46 times the MRHD (on an AUC basis at a maternal oral dose of 30 mg/kg/day). Embryolethality consisted of increased post-implantation loss that was due to elevated incidences of both early and late resorptions. No developmental toxicity was observed in rabbits at an exposure approximately 7 times the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day). In a pre- and post-natal development study in pregnant female rats dosed orally from gestation day 6 through lactation day 20, adverse findings observed in pups included decreased survival from birth to post-natal day 4 (due to increased stillbirths and early neonatal deaths), decreased birth weight, decreased body weight gain during the pre-weaning phase, increased incidence of malrotated forelimbs during the pre-weaning phase, and decreased cytotoxic T cells on PND 35 with recovery by PND 65 at exposures approximately 24 times the MRHD (on an AUC basis at a maternal oral dose of 25 mg/kg/day). Developmental delays (that may be secondary to decreased body weight gain) were observed in males and females at exposures approximately 24 times the MRHD (on an AUC basis at a maternal oral dose of 25 mg/kg/day). These findings included decreased forelimb and hindlimb grip strengths, and delayed mean age of sexual maturity. No developmental toxicity was observed in rats at an exposure approximately 5 times the MRHD (on an AUC basis at a maternal oral dose of 5 mg/kg/day).
Pediatric Use of Olumiant
Pediatric Use The safety and effectiveness of OLUMIANT in pediatric patients have not been established.
Overdosage Information for Olumiant
Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered in clinical trials without dose-limiting toxicity. Pharmacokinetic data of a single dose of 40 mg in healthy volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 24 hours. In case of an overdose, it is recommended that the patient should be monitored for signs and symptoms of adverse reactions.
Patients who develop adverse reactions should receive appropriate treatment.
Clinical Studies of Olumiant
Rheumatoid Arthritis
The OLUMIANT clinical development program included two dose-ranging trials and four confirmatory phase 3 trials in patients with rheumatoid arthritis (RA). Although other doses have been studied, the recommended dosage of OLUMIANT is 2 mg once daily. Dose-Ranging Studies The dose-ranging studies RA-1 (NCT01185353) and RA-2 (NCT01469013) included a 12-week randomized comparison of baricitinib 1, 2, 4, and 8 mg orally once daily versus placebo in 301 and 145 patients, respectively. The results from the dose-ranging studies are shown in Table 11. In dose-ranging Study RA-1, the observed ACR response was similar for baricitinib 1 and 2 mg daily and for baricitinib 4 and 8 mg daily, with the highest response for baricitinib 8 mg daily.
In dose-ranging Study RA-2, there was not a clear trend of dose response, with similar response rates for 1 mg and 4 mg and 2 mg and 8 mg. Table 11: Proportion of Patients with ACR20 Response at Week 12 in Dose-Ranging RA Studies % ACR20 Responders Dose-Ranging Study Placebo Baricitinib 1 mg daily Baricitinib 2 mg daily Baricitinib 4 mg daily Baricitinib 8 mg daily RA-1 (N=301) 41 57 54 75 78 RA-2 (N=145) 31 67 83 67 88 Confirmatory Studies The efficacy and safety of OLUMIANT 2 mg once daily was assessed in two confirmatory phase 3 trials. These trials were randomized, double-blind, multicenter studies in patients with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR)/European League Against Rheumatism 2010 criteria.
Patients over 18 years of age were eligible if at least 6 tender and 6 swollen joints were present at baseline. The two studies (Studies RA-3 and RA-4) evaluated OLUMIANT 2 mg and baricitinib 4 mg. Study RA-3 (NCT01721057) was a 24-week trial in 684 patients with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to conventional DMARDs (cDMARDs). Patients received OLUMIANT 2 mg or 4 mg once daily or placebo added to existing background cDMARD treatment.
From Week 16, non-responding patients could be rescued to receive baricitinib 4 mg once daily. The primary endpoint was the proportion of patients who achieved an ACR20 response at Week 12. Study RA-4 (NCT01721044) was a 24-week trial in 527 patients with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to 1 or more TNF inhibitor therapies with or without other biologic DMARDs (TNFi-IR). Patients received OLUMIANT 2 mg or baricitinib 4 mg once daily or placebo added to background cDMARD treatment. From Week 16, non-responding patients could be rescued to receive baricitinib 4 mg once daily.
The primary endpoint was the proportion of patients who achieved an ACR20 response at Week 12. Clinical Response The percentages of OLUMIANT-treated patients achieving ACR20, ACR50, and ACR70 responses, and Disease Activity Score (DAS28-CRP) <2.6 in Studies RA-3 and RA-4 are shown in Table 8. Patients treated with OLUMIANT had higher rates of ACR response and DAS28-CRP <2.6 versus placebo-treated patients at Week 12 (Studies RA-3 and RA-4) ( Table 12 ). In Study RA-4, higher ACR20 response rates ( Figure 4 ) were observed as early as 1 week with OLUMIANT 2 mg versus placebo. In Study RA-4, the proportions of patients achieving DAS28-CRP <2.6 who had at least 3 active joints at the end of Week 24 were 18.2% and 10.5%, in the placebo and OLUMIANT 2 mg arms, respectively. Table 12: Clinical Response in RA Studies RA-3 and RA-4 a a Patients who were rescued or discontinued treatment were considered as non-responders in the analyses. b 95% confidence interval for the difference (∆) in response rate between OLUMIANT treatment and placebo (Study RA-3, Study RA-4). Percent of Patients cDMARD-IR TNFi-IR Study RA-3 Study RA-4 Placebo + cDMARDs OLUMIANT 2 mg/day + cDMARDs ∆ (95% CI) b Placebo + cDMARDs OLUMIANT 2 mg/day + cDMARDs ∆ (95% CI) b N 228 229 176 174 ACR 20 Week 12 % 39 66 27 27 49 22 Week 24 % 42 61 19 27 45 18 ACR 50 Week 12 % 13 34 21 8 20 12 Week 24 % 21 41 20 13 23 10 ACR 70 Week 12 % 3 18 15 2 13 11 Week 24 % 8 25 17 3 13 10 DAS28-CRP<
Week 12 % 9 26 4 11 Week 24 % 11 31
6 11 (-1, 11) The effects of OLUMIANT treatment on the components of the ACR response criteria for Studies RA-3 and RA-4 are shown in Table 13. Table 13: Components of ACR Response at Week 12 in RA Studies RA-3 and RA-4 a a Data shown are mean (standard deviation). b Visual analog scale: 0=best, 100=worst. c Health Assessment Questionnaire–Disability Index: 0=best, 3=worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. cDMARD-IR TNFi-IR Study RA-3 Study RA-4 Placebo + cDMARDs OLUMIANT 2 mg/day + cDMARDs Placebo + cDMARDs OLUMIANT 2 mg/day + cDMARDs N 228 229 176 174 Number of Tender Joints (0-68) Baseline 24 24 28 31 Week 12 15 11 20 19 Number of Swollen Joints (0-66) Baseline 13 14 17 19 Week 12 8 5 12 10 Pain b Baseline 57 60 65 62 Week 12 43 34 55 46 Patient Global Assessment b Baseline 60 62 66 67 Week 12 44 36 56 46 Physician Global Assessment b Baseline 62 64 67 67 Week 12 41 33 50 36 Disability Index (HAQ-DI) c Baseline 1.50 1.51 1.78 1.71 Week 12 1.17 0.96 1.59 1.31 hsCRP (mg/L) Baseline 17.7 18.2 20.6
Week 12 17.2 8.6 19.9 13.5 Figure 4: Percent of RA Patients
Achieving ACR20 in Study RA-4 Figure 4 Physical Function Response Improvement in physical function was measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI). Patients receiving OLUMIANT 2 mg demonstrated greater improvement from baseline in physical functioning compared to placebo at Week 24. The mean difference (95% CI) from placebo in HAQ-DI change from baseline at Week 24 was -0.24 (-0.35, -0.14) in Study RA-3 and -0.23 (-0.35, -0.12) in Study RA-4. Other Health Related Outcomes General health status was assessed by the Short Form health survey (SF-36). In Studies RA-3 and RA-4, compared to placebo, patients treated with OLUMIANT 2 mg demonstrated greater improvement from baseline in the physical component summary (PCS) score and the physical function, role physical, bodily pain, vitality, and general health domains at Week 12, with no consistent improvements in the mental component summary (MCS) scores or the role emotional, mental health, and social functioning domains.
COVID-19
The efficacy and safety of baricitinib were assessed in 2 Phase 3, randomized, double-blind, placebo-controlled clinical trials: COVID I (NCT04401579), which evaluated the combination of baricitinib 4 mg + remdesivir compared to placebo + remdesivir. COVID II (NCT04421027), which evaluated baricitinib 4 mg compared to placebo. Patients could remain on background therapy, as defined per local guidelines.
An additional exploratory sub-study in patients requiring invasive mechanical ventilation or ECMO at baseline was also conducted under this protocol and analyzed separately. COVID I A randomized, double-blind, placebo-controlled clinical trial (NCT04401579) of hospitalized adults with confirmed SARS-CoV-2 infection compared treatment with baricitinib plus remdesivir (n = 515) with placebo plus remdesivir (n = 518). Patients had to have laboratory-confirmed SARS-CoV-2 infection as well as at least one of the following to be enrolled in the trial: radiographic infiltrates by imaging, SpO 2 ≤94% on room air, a requirement for supplemental oxygen, or a requirement for mechanical ventilation or ECMO. Patients treated with the combination received the following regimen: Baricitinib 4 mg once daily (orally) for up to 14 days or until hospital discharge, whichever came first Remdesivir 200 mg on Day 1 and 100 mg once daily (via intravenous infusion) on subsequent days for a total treatment duration of 10 days or until hospital discharge In this study prophylaxis for venous thromboembolic event (VTEs) was recommended for all patients unless a major contraindication was noted. For the overall population (N = 1033 patients) at randomization, mean age was 55 years (with 30% of patients aged 65 or older); 63% of patients were male, 51% were Hispanic or Latino, 48% were White, 15% were Black or African American, and 10% were Asian; 14% did not require supplemental oxygen, 55% required supplemental oxygen, 21% required non-invasive ventilation or high-flow oxygen, and 11% required invasive mechanical ventilation or ECMO. The most common comorbidities were obesity (56%), hypertension (52%), and type 2 diabetes (37%). Demographics and disease characteristics were balanced across the combination group and the placebo group.
The primary endpoint, for the intent to treat population, was time to recovery within 29 days after randomization. Recovery was defined as being discharged from the hospital without limitations on activities, being discharged from the hospital with limitations on activities and/or requiring home oxygen or hospitalized but not requiring supplemental oxygen and no longer requiring medical care. The key secondary endpoint was clinical status on Day 15 assessed on an 8-point ordinal scale (OS) consisting of the following categories: Not hospitalized, no limitations on activities ; Not hospitalized, limitation on activities and/or requiring home oxygen ; Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care ; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) ; Hospitalized, requiring supplemental oxygen ; Hospitalized, on non-invasive ventilation or high-flow oxygen devices ; Hospitalized, on invasive mechanical ventilation or ECMO ; and Death For the overall population, the median time to recovery (defined as discharged from hospital or hospitalized but not requiring supplemental oxygen or ongoing medical care) was 7 days for baricitinib + remdesivir compared to 8 days for placebo + remdesivir.
Patients assigned to baricitinib + remdesivir were more likely to have a better clinical status (according to an 8-point ordinal scale) at Day 15 compared to patients assigned to placebo + remdesivir. The proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 29 was lower in baricitinib + remdesivir (23%) compared to placebo + remdesivir (28%). Patients who required non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO) at baseline needed to worsen by at least 1 point on an 8-point ordinal scale to progress. The proportion of patients who died by Day 29 was 4.7% (24/515) for baricitinib + remdesivir compared to 7.1% (37/518) for placebo + remdesivir.
COVID II A randomized, double-blind, placebo-controlled clinical trial (NCT04421027) of hospitalized adults with confirmed SARS-CoV-2 infection compared treatment with baricitinib 4mg once daily (n = 764) with placebo (n = 761) for 14 days or hospital discharge, whichever came first. Patients could remain on background standard of care, as defined per local guidelines, including antimalarials, antivirals, corticosteroids, and/or azithromycin. In this study prophylaxis for venous thromboembolic event (VTE) was required for all patients unless contraindicated.
The most frequently used therapies at baseline were: corticosteroids (79% of patients, mostly dexamethasone) remdesivir (19% of patients) Patients had to have laboratory-confirmed SARS-CoV-2 infection, at least one instance of elevation in at least one inflammatory marker above the upper limit of normal according to local laboratory ranges (CRP, D-dimer, LDH, ferritin), and at least one of the following to be enrolled in the trial: radiographic infiltrates by imaging, SpO 2 <94% on room air, evidence of active COVID infection (with clinical symptoms including any of the following: fever, vomiting, diarrhea, dry cough, tachypnea defined as respiratory rate >24 breaths/min) or requirement for supplemental oxygen. For the overall population (N = 1525 patients) at randomization, mean age was 58 years (with 33% of patients aged 65 or older); 63% of patients were male, 60% were White, 5% were Black or African American, 11% were Asian; 12% did not require supplemental oxygen (OS 4), 63% required supplemental oxygen (OS 5), 24% required non-invasive ventilation or high-flow oxygen (OS 6). The most common comorbidities were hypertension (48%), obesity (33%), and type 2 diabetes (29%). Demographics and disease characteristics were balanced across the baricitinib and placebo groups. The primary endpoint was the proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation within the first 28-days of the study.
Patients who required non-invasive ventilation/high-flow oxygen at baseline needed to worsen by at least 1 point on an 8-point OS to progress (refer to the description of COVID I for the definition of the 8-point OS). A key secondary endpoint was all-cause mortality by Day 28. The estimated proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation was lower in patients treated with baricitinib (27.8%) compared to placebo (30.5%), but this effect was not statistically significant. The proportion of patients who died by Day 28 was 8.1% (62/764) for baricitinib compared to 13.3% (101/761) for placebo. COVID II Exploratory Sub-Study In a separate group of patients requiring invasive mechanical ventilation or ECMO at baseline and enrolled in an addendum to COVID II, a pre-specified exploratory analysis showed that the proportion who died by Day 28 was 39.2% (20/51) for baricitinib compared to 58.0% (29/50) for placebo.
Alopecia Areata Two randomized, double-blind, placebo-controlled trials enrolled a total of 1200
patients, with alopecia areata (AA), who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than 6 months. The trials enrolled males 18 to 60 years of age and females 18 to 70 years of age. Among the patients enrolled, 61% were female, 2% were 65 years of age or older, and 52% were White, 36% were Asian, and 8% were Black.
At baseline, 53% of patients had at least 95% scalp hair loss, 34% had their current episode lasting at least 4 years, 69% had significant gaps in eyebrow hair or no notable eyebrow hair, and 58% had significant gaps in eyelashes or no notable eyelashes. In the Phase 3 portion of Trial AA-1 and in Trial AA-2, patients received OLUMIANT 2 mg, OLUMIANT 4 mg, or placebo once daily. Both trials assessed the proportion of patients who achieved at least 80% scalp hair coverage (SALT score of ≤20) at Week 36 as the primary endpoint.
Other outcomes at Week 36 included the proportion of patients who achieved at least 90% scalp hair coverage (SALT score of ≤10), patients with Scalp Hair Assessment PRO™ score of 0 or 1 with at least 2-point reduction on the 5-point scale, and assessments of eyebrow and eyelash hair loss. Clinical Response The results of the OLUMIANT trials (AA-1 and AA-2) are provided in Table 14 and Figure 5. Table 14: Clinical Response at Week 36 in Patients with Severe AA a Not statistically significant under the multiplicity control plan b Patients evaluated scalp hair coverage on a 5-point scale where 0 = No missing hair (0% of scalp hair missing; full head of hair), 1 = A limited area of scalp hair loss (1% to 20%), 2 = moderate scalp hair loss (21% to 49%), 3 = a large area of scalp hair loss (50% to 94%), and 4 = nearly all or all scalp hair loss (95% to 100%). Trial AA-1 Trial AA-2 Placebo OLUMIANT 2 mg/day OLUMIANT 4 mg/day Placebo OLUMIANT 2 mg/day OLUMIANT 4 mg/day Number of subjects with at least 50% scalp hair loss at baseline N 189 184 281 156 156 234 SALT ≤ 20 Difference from Placebo (95% CI) 5% 22% 16% 35% 30% 3% 17% 15% 32% 30% SALT ≤ 10 Difference from Placebo (95% CI) 4% 13% 9% 26% 22% 1% 11% 10% a 24% 23% Number of subjects reporting Scalp Hair Assessment PRO™ score ≥3 at baseline N 181 175 275 151 149 215 Scalp Hair Assessment PRO score of 0 or 1 b Difference from Placebo (95% CI) 5% 16% 11% 33% 28% 4% 16% 12% 34% 30% Among patients with substantial eyebrow and eyelash hair loss at baseline, an improvement in eyebrow and eyelash coverage was observed on OLUMIANT 4 mg once daily dosage at Week 36. Figure 5: Percent of Patients Achieving SALT ≤20 Analyses by age, gender, race, and body weight did not identify differences in response to 36-weeks of treatment with OLUMIANT among these subgroups. SALT ≤20 response rates were higher in all dose groups in patients with baseline SALT 50 to 94 versus SALT 95 to 100. See Table 15. Table 15: SALT ≤20 at Week 36 by Baseline SALT Severity in AA Trials AA-1 and AA-2 Placebo OLUMIANT 2 mg/day OLUMIANT 4 mg/day 50 % to 94% Scalp Hair Loss N SALT ≤20 166 8% 147 33% 248 48% 95 % to 100% Scalp Hair Loss N SALT ≤20 178 1% 193 10% 267 21% In AA-2, patients who achieved adequate response (SALT ≤20) to OLUMIANT 4 mg once daily at 52 weeks of treatment entered a randomized down-titration period and received OLUMIANT 2 mg once daily or remained on OLUMIANT 4 mg once daily.
After an additional 24 weeks of treatment (76 weeks total), 75% (30/40) of patients randomized to OLUMIANT 2 mg once daily maintained response and 98% (41/42) of patients who remained on OLUMIANT 4 mg once daily maintained response. Figure 5
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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