Otezla Drug Information
Generic name: APREMILAST
Phosphodiesterase 4 Inhibitor [EPC]
Uses of Otezla
Psoriatic Arthritis
OTEZLA is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis. OTEZLA XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis.
Plaque Psoriasis
OTEZLA/OTEZLA XR is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. OTEZLA is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. OTEZLA XR is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 50 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Oral Ulcers Associated with Behçet's Disease
OTEZLA/OTEZLA XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.
Dosage & Administration of Otezla
| 10 mg | 10 mg |
|---|---|
Side Effects of Otezla
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Psoriatic Arthritis Clinical Trials OTEZLA was evaluated in three multicenter, randomized, double-blind, placebo-controlled trials (PsA-1, PsA-2, and PsA-3) of similar design in adult subjects with active psoriatic arthritis . Across the three trials, there were 1493 subjects randomized equally to placebo, OTEZLA 20 mg twice daily or OTEZLA 30 mg twice daily. Titration was used over the first 5 days . Placebo subjects whose tender and swollen joint counts had not improved by at least 20% were re-randomized 1:1 in a blinded fashion to either OTEZLA 20 mg twice daily or 30 mg twice daily at week 16 while OTEZLA subjects remained on their initial treatment.
Subjects ranged in age from 18 to 83 years, with an overall median age of 51 years. The majority of the most common adverse reactions presented in Table 3 occurred within the first 2 weeks of treatment and tended to resolve over time with continued dosing. Diarrhea, headache, and nausea were the most commonly reported adverse reactions.
The most common adverse reactions leading to discontinuation for subjects taking OTEZLA were nausea (1.8%), diarrhea (1.8%), and headache (1.2%). The proportion of subjects with psoriatic arthritis who discontinued treatment due to any adverse reaction was 4.6% for subjects taking OTEZLA 30 mg twice daily and 1.2% for placebo-treated subjects. Table 3. Adverse Reactions Reported in ≥ 2% of Adult Subjects with Active Psoriatic Arthritis on OTEZLA 30 mg Twice Daily and ≥ 1% than That Observed in Subjects on Placebo up to Day 112 (Week 16) Placebo OTEZLA 30 mg BID BID = twice daily. Adverse Reactions Day 1 to 5 (N = 495) n (%) n (%) indicates number of subjects and percent.
Day 6 to Day 112 (N = 490) n (%) Day 1 to 5 (N = 497) n (%) Day 6 to Day 112 (N = 493) n (%) Diarrhea Of the reported gastrointestinal adverse reactions, 1 subject experienced a serious adverse reaction of nausea and vomiting in OTEZLA 30 mg twice daily; 1 subject treated with OTEZLA 20 mg twice daily experienced a serious adverse reaction of diarrhea; 1 subject treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction of headache. 6 8 46 38 Nausea 7 15 37 44 Headache 9 11 24 29 Upper respiratory tract infection Of the reported adverse drug reactions none were serious. 3 9 3 19 Vomiting 2 2 4 16 Nasopharyngitis 1 8 1 13 Abdominal pain upper 0 1 3 10 Moderate to Severe Plaque Psoriasis Clinical Trials Adverse Reactions from Clinical Trials in Adults The safety of OTEZLA was assessed in 1426 subjects in three randomized, double-blind, placebo-controlled trials in adult subjects with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy. Subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days . Subjects ranged in age from 18 to 83 years, with an overall median age of 46 years.
Diarrhea, nausea, and upper respiratory tract infection were the most commonly reported adverse reactions (see Table 4 ). The most common adverse reactions leading to discontinuation for subjects taking OTEZLA were nausea (1.6%), diarrhea (1.0%), and headache (0.8%). The proportion of subjects with plaque psoriasis who discontinued treatment due to any adverse reaction was 6.1% for subjects treated with OTEZLA 30 mg twice daily and 4.1% for placebo-treated subjects. Table 4. Adverse Reactions Reported in ≥ 1% of Adult Subjects with Moderate to Severe Plaque Psoriasis on OTEZLA and With Greater Frequency Than in Subjects on Placebo up to Day 112 (Week 16) Adverse Reactions Placebo (N = 506) n (%) OTEZLA 30 mg BID BID = twice daily. (N = 920) n (%) Diarrhea 32 160 Nausea 35 155 Upper respiratory tract infection 31 84 Tension headache 21 75 Headache 19 55 Abdominal pain Two subjects treated with OTEZLA experienced serious adverse reaction of abdominal pain. 11 39 Vomiting 8 35 Fatigue 9 29 Dyspepsia 6 29 Decreased appetite 5 26 Insomnia 4 21 Back pain 4 20 Migraine 5 19 Frequent bowel movements 1 17 Depression 2 12 Bronchitis 2 12 Tooth abscess 0 10 Folliculitis 0 9 Sinus headache 0 9 Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1184) subjects following discontinuation of treatment with OTEZLA. OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (PSOR-3) in adults with moderate to severe plaque psoriasis of the scalp . A total of 302 subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. The most commonly reported adverse reactions that occurred at a higher rate in the OTEZLA group than in the placebo group were: diarrhea (31% vs. 11%), nausea (22% vs. 6%), headache (12% vs. 5%), and vomiting (6% vs. 2%). The proportion of subjects who discontinued treatment because of any adverse reaction during the 16-week placebo-controlled period of the trial was 6% for subjects who received OTEZLA 30 mg twice daily and 3% for subjects who received placebo.
Gastrointestinal adverse reactions that led to discontinuation of treatment were diarrhea (3% vs. 0%), nausea (1.5% vs. 1%), and vomiting (1.5% vs. 0%) in the OTEZLA group compared to placebo. OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (PSOR-5) in adults with moderate to severe plaque psoriasis of the genital area . A total of 289 subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Overall, the safety profile observed in the OTEZLA group during the placebo-controlled phase was consistent with the safety profile previously established in adult subjects with moderate to severe plaque psoriasis.
Adverse Reactions from Clinical Trials in Pediatric Subjects 6 to 17 Years of Age OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (PSOR-6) in pediatric subjects 6 to 17 years of age with moderate to severe plaque psoriasis . A total of 245 subjects were randomized to receive OTEZLA (163 subjects, at a dosage of 20 mg twice daily or 30 mg twice daily, based on body weight) or placebo (82 subjects) twice daily during the 16-week placebo-controlled phase of the trial. The trial also included a 36-week extension phase during which all subjects received OTEZLA 20 mg or 30 mg twice daily. Overall, the safety profile observed in pediatric subjects treated with OTEZLA during the study was consistent with the safety profile established in adult subjects with moderate to severe plaque psoriasis.
Mild to Moderate Plaque Psoriasis Clinical Trial in Adults OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (PSOR-4) in adult subjects with mild to moderate plaque psoriasis . A total of 595 subjects were randomized to receive OTEZLA 30 mg twice daily (297 subjects) or placebo twice daily (298 subjects) during the placebo-controlled phase of the trial. The trial also included an open label extension phase during which all subjects received OTEZLA 30 mg twice daily. Overall, the safety profile observed in the OTEZLA group during the placebo-controlled phase was consistent with the safety profile previously established in adult subjects with moderate to severe plaque psoriasis.
Behçet's Disease Clinical Trials OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (BCT-002) in adult subjects with Behçet's Disease (BD) with active oral ulcers . A total of 207 subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days . After Week 12, all subjects received treatment with OTEZLA 30 mg twice daily. Subjects ranged in age from 19 to 72, with a mean age of 40 years.
Diarrhea, nausea, headache, and upper respiratory tract infection were the most commonly reported adverse reactions (see Table 5 ). The proportion of subjects with BD who discontinued treatment due to any adverse reaction during the placebo-controlled period of the trial, was 2.9% for subjects treated with OTEZLA 30 mg twice daily and 4.9% for placebo-treated subjects. Table 5. Adverse Reactions Reported in ≥ 5% of Adult Subjects with BD with Active Oral Ulcers on OTEZLA and with at Least 1% Greater Frequency than Subjects on Placebo up to Week 12 Adverse Reactions Placebo (N = 103) n (%) OTEZLA 30 mg twice daily (N = 104) n (%) Diarrhea There were no serious adverse reactions of diarrhea, nausea or vomiting. 21 43 Nausea 11 20 Headache 11 15 Upper respiratory tract infection 5 12 Abdominal pain upper 2 9 Vomiting 2 9 Back pain 6 8 Viral upper respiratory tract infection 5 7 Arthralgia 3 6 Other adverse reactions reported in subjects on OTEZLA in psoriatic arthritis, plaque psoriasis, and Behçet's Disease clinical trials are : Gastrointestinal Disorders: Gastroesophageal reflux disease Immune System Disorders: Hypersensitivity Investigations: Weight decrease Metabolism and Nutrition Disorders: Decreased appetite One subject treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction. Nervous System Disorders: Migraine Respiratory, Thoracic, and Mediastinal Disorders: Cough Skin and Subcutaneous Tissue Disorders: Rash
Warnings & Cautions for Otezla
Hypersensitivity Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported
during post marketing surveillance. Avoid the use of OTEZLA/OTEZLA XR in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue OTEZLA/OTEZLA XR and institute appropriate therapy.
Diarrhea, Nausea, and Vomiting
There have been reports of severe diarrhea, nausea, and vomiting associated with the use of OTEZLA. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting.
Monitor patients who are more susceptible to complications of diarrhea or vomiting. Patients who reduced dosage or discontinued OTEZLA generally improved quickly. Consider OTEZLA/OTEZLA XR dosage reduction or suspension if patients develop severe diarrhea, nausea, or vomiting.
Depression Treatment with apremilast is associated with an increased incidence of depression.
Before using OTEZLA/OTEZLA XR in patients with a history of depression and/or suicidal thoughts or behavior, carefully weigh the risks and benefits of treatment with OTEZLA/OTEZLA XR. Advise patients, their caregivers, and families of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Carefully evaluate the risks and benefits of continuing treatment with OTEZLA/OTEZLA XR if such events occur. Psoriatic Arthritis : During the 16-week placebo-controlled period of the 3 controlled clinical trials, 1.0% (10/998) of subjects treated with OTEZLA reported depression or depressed mood compared to 0.8% (4/495) treated with placebo.
During the clinical trials, 0.3% (4/1441) of subjects treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none in placebo treated subjects (0/495). Depression was reported as serious in 0.2% (3/1441) of subjects exposed to OTEZLA, compared to none in placebo-treated subjects (0/495). Instances of suicidal ideation and behavior have been observed in 0.2% (3/1441) of subjects while receiving OTEZLA, compared to none in placebo treated subjects (0/495). In the clinical trials, 2 subjects who received placebo committed suicide compared to none in OTEZLA-treated subjects. Plaque Psoriasis : During the 16-week placebo-controlled period of the 3 controlled clinical trials in adult subjects with moderate to severe plaque psoriasis, 1.3% (12/920) of subjects treated with OTEZLA reported depression compared to 0.4% (2/506) treated with placebo. During the clinical trials, 0.1% (1/1308) of subjects treated with OTEZLA discontinued treatment due to depression compared with none in placebo-treated subjects (0/506). Depression was reported as serious in 0.1% (1/1308) of subjects exposed to OTEZLA, compared to none in placebo-treated subjects (0/506). Instances of suicidal behavior have been observed in 0.1% (1/1308) of subjects while receiving OTEZLA, compared to 0.2% (1/506) in placebo-treated subjects.
In the clinical trials, one subject treated with OTEZLA attempted suicide while one who received placebo committed suicide. During the 16-week placebo-controlled period of the clinical trial in adults with mild to moderate plaque psoriasis, the incidence of subjects reporting depression was similar to what was observed in the adult moderate to severe plaque psoriasis trials. Behçet's Disease : During the placebo-controlled period of the phase 3 trial, 1% (1/104) of subjects treated with OTEZLA reported depression/depressed mood compared to 1% (1/103) treated with placebo.
None of these reports of depression was serious or led to discontinuation from the trial. No instances of suicidal ideation or behavior were reported during the placebo-controlled period of the phase 3 trial in subjects treated with OTEZLA (0/104) or treated with placebo (0/103).
Weight Decrease Weight loss may occur in adult or pediatric patients treated
with OTEZLA/OTEZLA XR. Regularly monitor the weight of patients treated with OTEZLA/OTEZLA XR. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of OTEZLA/OTEZLA XR . Weight Loss in Adult Patients During the placebo-controlled period of the trials in psoriatic arthritis (PsA), weight decrease between 5%-10% of body weight was reported in 10% (49/497) of subjects treated with OTEZLA 30 mg twice daily compared to 3.3% (16/495) treated with placebo. During the placebo-controlled period of the trials in adults with moderate to severe plaque psoriasis, weight decrease between 5%-10% of body weight occurred in 12% (96/784) of subjects treated with OTEZLA compared to 5% (19/382) treated with placebo. Weight decrease of ≥ 10% of body weight occurred in 2% (16/784) of subjects treated with OTEZLA 30 mg twice daily compared to 1% (3/382) subjects treated with placebo.
During the placebo-controlled period of the clinical trial in adults with mild to moderate plaque psoriasis, weight decrease was similar to what was observed in the trials of adults with moderate to severe plaque psoriasis. During the placebo-controlled period of the phase 3 trial in Behçet's Disease, weight decrease > 5% of body weight was reported in 4.9% (5/103) of subjects treated with OTEZLA 30 mg twice daily compared to 3.9% (4/102) subjects treated with placebo. Weight Loss in Pediatric Patients During the placebo-controlled period of the clinical trial in pediatric subjects 6 years of age and older with moderate to severe plaque psoriasis, weight decrease between 5%-10% of body weight occurred in 12% (19/163) of pediatric subjects treated with OTEZLA compared to 2.5% (2/80) of pediatric subjects treated with placebo.
Weight decrease of ≥ 10% of body weight occurred in 1% (1/163) of pediatric subjects treated with OTEZLA twice daily compared to 0% (0/80) of pediatric subjects treated with placebo. Closely monitor growth (height and weight) in pediatric patients treated with OTEZLA/OTEZLA XR. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
Drug Interactions Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in
a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of OTEZLA/OTEZLA XR. Therefore, the use of cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with OTEZLA/OTEZLA XR is not recommended .
Drug Interactions with Otezla
Strong
CYP450 Inducers Co-administration with strong CYP450 inducers (such as rifampin) decreases apremilast exposure and may result in loss of efficacy of OTEZLA/OTEZLA XR .
Pregnancy Safety for Otezla
Pregnancy Risk Summary Available data with OTEZLA use in pregnant women have not identified a drug-associated risk of major birth defects or adverse maternal or fetal outcomes (see Data ). In animal embryo-fetal development studies, the administration of apremilast to pregnant cynomolgus monkeys during organogenesis resulted in dose-related increases in abortion/embryo-fetal death at dose exposures approximately 2-times the maximum recommended human therapeutic dose (MRHD) and no adverse effect at an exposure of 1.4-times the MRHD. When apremilast was administered to pregnant mice during organogenesis, there were no apremilast-induced malformations up to exposures 4-times the MRHD. Based on findings from animal reproduction studies, OTEZLA/OTEZLA XR may increase the risk for fetal loss (see Data ). Advise pregnant women of the potential risk of fetal loss. The background risk of major birth defects and miscarriage for the indicated populations is 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% to 4% and 15% to 20%, respectively. Data Human Data A pregnancy registry conducted by the Organization of Teratology Information Specialists (OTIS) in the United States and Canada assessed the risk of major birth defects in liveborn infants of women with psoriatic arthritis, psoriasis, or Behçet's Disease exposed to apremilast in the first trimester. The study compared pregnant women treated with apremilast (n = 15) with disease matched pregnant women who were not exposed to apremilast (n = 106). In the apremilast-exposed cohort, there were no reports of liveborn infants with major birth defects nor miscarriages.
One stillbirth was reported in the apremilast exposed cohort. These data are limited by the small sample size of apremilast-exposed pregnancies. Animal Data In an embryo-fetal developmental study, pregnant cynomolgus monkeys were administered apremilast at doses of 20, 50, 200, or 1000 mg/kg/day during the period of organogenesis (gestation Days 20 through 50). There was a dose -related increase in spontaneous abortions, with most abortions occurring during Weeks 3 to 4 of dosing in the first trimester, at doses approximately 2-times the MRHD and greater (on an area under the curve basis at doses ≥ 50 mg/kg/day). No abortifacient effects were observed at a dose approximately 1.4-times the MRHD (on an AUC basis at a dose of 20 mg/kg/day). Although there was no evidence for a teratogenic effect at doses of 20 mg/kg/day and greater when examined at Day 100, aborted fetuses were not examined.
In an embryo-fetal development study in mice, apremilast was administered at doses of 250, 500, or 750 mg/kg/day to dams during organogenesis (GD 6 through 15). In a combined fertility and embryo-fetal development study in mice, apremilast was administered at doses of 10, 20, 40, or 80 mg/kg/day starting 15 days before cohabitation and continuing through GD 15. No teratogenic findings attributed to apremilast were observed in either study; however, there was an increase in post-implantation loss at doses corresponding to a systemic exposure of approximately 2-times the MRHD and greater (≥ 20 mg/kg/day). At doses of ≥ 20 mg/kg/day skeletal variations included incomplete ossification sites of tarsals, skull, sternebra, and vertebrae. No effects were observed at a dose approximately 1.3-times the MRHD (10 mg/kg/day). Apremilast distributed across the placenta into the fetal compartment in mice and monkeys. In a pre and postnatal study in mice, apremilast was administered to pregnant female mice at doses of 10, 80, or 300 mg/kg/day from Day 6 of gestation through Day 20 of lactation, with weaning on Day 21. Dystocia, reduced viability, and reduced birth weights occurred at doses corresponding to ≥ 4-times the MRHD (on an AUC basis at doses ≥ 80 mg/kg/day). No adverse effects occurred at a dose 1.3-times the MRHD (10 mg/kg/day). There was no evidence for functional impairment of physical development, behavior, learning ability, immune competence, or fertility in the offspring at doses up to 7.5-times the MRHD (on an AUC basis at a dose of 300 mg/kg/day).
Pediatric Use of Otezla
Pediatric Use OTEZLA Plaque Psoriasis The safety and effectiveness of OTEZLA have been established in pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Use of OTEZLA in these patients is supported by evidence from a 52-week adequate and well-controlled clinical trial (PSOR-6) in 245 pediatric subjects 6 years of age and older with moderate to severe plaque psoriasis. Weight loss in OTEZLA-treated pediatric subjects was comparable to weight loss observed in adults . Closely monitor growth (height and weight) in pediatric patients treated with OTEZLA. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
The safety and effectiveness of OTEZLA have not been established in pediatric patients below the age of 6 years or weighing less than 20 kg with moderate to severe plaque psoriasis. Psoriatic Arthritis The safety and effectiveness of OTEZLA have been established for pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis. Use of OTEZLA in these patients is supported by evidence from adequate and well controlled trials of OTEZLA in adults with psoriatic arthritis, pharmacokinetic data from adult patients with psoriatic arthritis, adult patients with psoriasis, and pediatric patients with psoriasis, and safety data from a clinical trial in 245 pediatric patients 6 years of age and older with psoriasis.
Steady-state exposure of OTEZLA in pediatric patients with psoriatic arthritis is estimated to be comparable to adults with psoriatic arthritis and pediatric patients with psoriasis . Closely monitor growth (height and weight) in OTEZLA-treated pediatric patients. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted . The safety and effectiveness of OTEZLA have not been established in pediatric patients below the age of 6 years or weighing less than 20 kg with psoriatic arthritis. Behçet's Disease The safety and effectiveness of OTEZLA have not been established in pediatric patients with psoriatic arthritis or oral ulcers associated with Behçet's Disease.
OTEZLA XR Plaque Psoriasis and Psoriatic Arthritis The safety and effectiveness of OTEZLA XR have been established for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in pediatric patients 6 years of age and older and weighing at least 50 kg. Use of OTEZLA XR in these patients is supported by pharmacokinetic data from healthy adults demonstrating comparable PK exposure between OTEZLA XR 75 mg once daily and OTEZLA 30 mg twice daily, which is the recommended OTEZLA dosage for pediatric patients weighing at least 50 kg . Closely monitor growth (height and weight) in pediatric patients treated with OTEZLA XR. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted. The safety and effectiveness of OTEZLA XR have not been established in pediatric patients below the age of 6 years or weighing less than 50 kg with moderate to severe plaque psoriasis or psoriatic arthritis.
Behçet's Disease The safety and effectiveness of OTEZLA XR have not been established in pediatric patients with oral ulcers associated with Behçet's Disease.
Contraindications for Otezla
OTEZLA/OTEZLA XR is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation . Known hypersensitivity to apremilast or to any of the excipients in the formulation
Clinical Studies of Otezla
Adult Psoriatic Arthritis
The safety and efficacy of OTEZLA was evaluated in three multicenter, randomized, double-blind, placebo-controlled trials (PsA-1, PsA-2, and PsA-3 ) of similar design. A total of 1493 adult subjects with active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior or current treatment with disease-modifying antirheumatic drug (DMARD) therapy were randomized. Subjects enrolled in these trials had a diagnosis of PsA for at least 6 months.
One qualifying psoriatic skin lesion of at least 2 cm in diameter was required in Trial PsA-3. Previous treatment with a biologic, including TNF blockers was allowed (up to 10% could be TNF blocker therapeutic failures). Across the three trials, subjects were randomly assigned to placebo (n = 496), OTEZLA 20 mg (n = 500), or OTEZLA 30 mg (n = 497) given orally twice daily. Titration was used over the first 5 days . Subjects were allowed to receive stable doses of concomitant methotrexate, sulfasalazine, leflunomide, low dose oral corticosteroids (equivalent to ≤ 10 mg of prednisone a day), and/or nonsteroidal anti-inflammatory drugs (NSAIDs) during the trial. Treatment assignments were stratified based on small molecule DMARD use at baseline in Trials PsA-1, PsA-2 and PsA-3. There was an additional stratification of body surface area (BSA) > 3% with psoriasis in Trial PsA-3. The subjects who were therapeutic failures of > 3 agents for PsA (small molecules or biologics), or > 1 biologic TNF blocker were excluded.
The primary endpoint was the percentage of subjects achieving American College of Rheumatology (ACR) 20 response at Week 16. Placebo-controlled efficacy data were collected and analyzed through Week 24. Subjects whose tender and swollen joint counts had not improved by at least 20% were considered non-responders at Week 16. Placebo non-responders were re-randomized 1:1 in a blinded fashion to either OTEZLA 20 mg twice daily or 30 mg twice daily following the titration schema . OTEZLA subjects remained on their initial treatment. At Week 24, all remaining placebo subjects were re-randomized to either 20 mg twice daily or 30 mg twice daily. Subjects with subtypes of PsA were enrolled across the three trials, including symmetric polyarthritis (62.0%), asymmetric oligoarthritis (27.0%), distal interphalangeal (DIP) joint arthritis (6.0%), arthritis mutilans (3.0%), and predominant spondylitis (2.1%). The median duration of PsA disease was 5 years.
Subjects received concomitant therapy with at least one DMARD (65.0%), MTX (55.0%), SSZ (9.0%), LEF (7.0%), low dose oral corticosteroids (14.0%), and NSAIDs (71.0%). Prior treatment with small molecule DMARDs only was reported in 76.0% of subjects and prior treatment with biologic DMARDs was reported in 22.0% of subjects, which includes 9.0% who had failed prior biologic DMARD treatment. Clinical Response in Subjects with Psoriatic Arthritis The percent of subjects achieving ACR 20, 50 and 70 responses in Trials PsA-1, PsA-2, and PsA-3 are presented in Table 6 below. OTEZLA ± DMARDs, compared with Placebo ± DMARDs resulted in a greater improvement in signs and symptoms of psoriatic arthritis as demonstrated by the proportion of subjects with an ACR 20 response at Week 16. Table 6. Proportion of Adult Subjects With Active Psoriatic Arthritis With ACR Responses in Trials PsA-1, PsA-2 and PsA-3 PsA-1 PsA-2 PsA-3 N N is number of randomized and treated subjects.
Placebo ± DMARDs N = 168 OTEZLA 30 mg twice daily ± DMARDs N = 168 Placebo ± DMARDs N = 159 OTEZLA 30 mg twice daily ± DMARDs N = 162 Placebo ± DMARDs N = 169 OTEZLA 30 mg twice daily ± DMARDs N = 167 ACR 20 Week 16 19% 38% Statistically significantly different from placebo (p < 0.05). 19% 32% 18% 41% ACR 50 Week 16 6% 16% 5% 11% 8% 15% ACR 70 Week 16 1% 4% 1% 1% 2% 4% OTEZLA 30 mg twice daily resulted in improvement for each ACR component, compared to placebo at Week 16 in Trial PsA-1 (Table 7). Consistent results were observed in Trials PsA-2 and PsA-3. Table 7. ACR Components Mean Change from Baseline at Week 16 in Trial PsA-1 Placebo (N N reflects randomized subjects; actual number of subjects evaluable for each endpoint may vary by timepoint. = 168) OTEZLA 30 mg twice daily (N = 168) Mean changes from baseline are least square means from analyses of covariance. Number of tender joints Scale 0-78. Sample Size 166 164 Baseline 23 23 Mean Change at Week 16 -2 -7 Number of swollen joints Scale 0-76. Sample Size 166 164 Baseline 13 13 Mean Change at Week 16 -2 -5 Patient's assessment of pain VAS = Visual Analog Scale; 0 = best, 100 = worst. Sample Size 165 159 Baseline 61 58 Mean Change at Week 16 -6 -14 Patient's global assessment of disease activity Sample Size 165 159 Baseline 59 56 Mean Change at Week 16 -3 -10 Physician's global assessment of disease activity Sample Size 158 159 Baseline 55 56 Mean Change at Week 16 -8 -19 HAQ-DI HAQ-DI = Health Assessment Questionnaire – Disability Index; 0 = best, 3 = worst; measures the subject's ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity. score Sample Size 165 159 Baseline 1.2
Mean Change at Week 16 -0.09 -0.2
CRP CRP = C-reactive protein; Reference range 00.5 mg/dL. Sample Size 166 167 Baseline 1.1
Mean Change at Week 16 0.1 -0.1 Treatment with
OTEZLA resulted in improvement in dactylitis and enthesitis in subjects with pre-existing dactylitis or enthesitis. Physical Function Response OTEZLA 30 mg twice daily demonstrated a greater improvement compared to placebo in mean change from baseline for the Health Assessment Questionnaire Disability Index (HAQDI) score at Week 16 in Trial PsA1. The proportions of HAQDI responders (≥ 0.3 improvement from baseline) at Week 16 for the OTEZLA 30 mg twice daily group were 38%, compared to 27%, for the placebo group in Trial PsA1. Consistent results were observed in Trials PsA2 and PsA3.
Adult Moderate to Severe Plaque Psoriasis Two multicenter, randomized, double-blind, placebo-controlled trials
(PSOR-1 and PSOR-2 ) enrolled a total of 1257 subjects 18 years of age and older with moderate to severe plaque psoriasis. Subjects were allowed to use low potency topical corticosteroids on the face, axilla and groin. Subjects with plaque psoriasis of the scalp were allowed to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions.
Trial PSOR-1 enrolled 844 subjects and Trial PSOR-2 enrolled 413 subjects. In both trials, subjects were randomized 2:1 to OTEZLA 30 mg twice daily (BID) or placebo for 16 weeks. Both trials assessed the proportion of subjects who achieved PASI-75 at Week 16 and the proportion of subjects who achieved an sPGA score of clear or almost clear at Week 16. Across both trials, subjects ranged in age from 18 to 83 years, with an overall median age of 46 years.
The mean baseline BSA involvement was 25.2% (median 21.0%), the mean baseline PASI score was 19.1 (median 16.8), and the proportion of subjects with an sPGA score of 3 (moderate) and 4 (severe) at baseline were 70.0% and 29.8%, respectively. Approximately 30% of all subjects had received prior phototherapy and 54% had received prior conventional systemic and/or biologic therapy for the treatment of psoriasis with 37% receiving prior conventional systemic therapy and 30% receiving prior biologic therapy. Approximately one-third of subjects had not received prior phototherapy, conventional systemic nor biologic therapy.
A total of 18% of subjects had a history of psoriatic arthritis. Clinical Response in Adult Subjects with Moderate to Severe Plaque Psoriasis The proportion of subjects who achieved PASI-75 responses, and an sPGA score of clear or almost clear, are presented in Table 8. Table 8. Clinical Response at Week 16 in Adults with Moderate to Severe Plaque Psoriasis in Trials PSOR-1 and PSOR-2 Trial PSOR-1 Trial PSOR-2 Placebo OTEZLA 30 mg BID Placebo OTEZLA 30 mg BID BID = twice daily. N N is number of randomized and treated subjects.
N = 282 N = 562 N = 137 N = 274 PASI PASI = Psoriasis Area and Severity Index. -75, n (%) 15 186 8 79 sPGA sPGA = Static Physician Global Assessment. of Clear or Almost Clear, n (%) 11 122 6 56 The median time to loss of PASI-75 response among the subjects re-randomized to placebo at Week 32 during the Randomized Treatment Withdrawal Phase was 5.1 weeks. Plaque Psoriasis Involving the Scalp Area A randomized, double-blind, placebo-controlled trial (PSOR-3 ) was conducted in 303 adult subjects with moderate to severe plaque psoriasis of the scalp. Enrolled subjects had a Scalp Physician Global Assessment (ScPGA) score of ≥ 3, Scalp Surface Area (SSA) involvement of ≥ 20%, an inadequate response or intolerance to at least one topical therapy for plaque psoriasis of the scalp, and moderate to severe plaque psoriasis (BSA involvement of ≥ 10%, sPGA of ≥ 3, and PASI score ≥ 12). Subjects were randomized 2:1 to receive either OTEZLA 30 mg twice daily (n = 201) or placebo twice daily (n = 102) for 16 weeks.
The primary endpoint was the proportion of subjects who achieved an ScPGA response at Week 16 (defined as ScPGA score of clear or almost clear with at least a 2-point reduction from baseline at Week 16). Secondary endpoints included the proportion of subjects with Whole Body Itch Numeric Rating Scale (NRS) response (defined as ≥ 4-point reduction from baseline) and the proportion of subjects with a Scalp Itch NRS response (defined as ≥ 4-point reduction from baseline). Subjects had a mean age of 46.9 years, 61.7% were men and 75.6% were white. At baseline, 76.9% of subjects had moderate plaque psoriasis of the scalp (ScPGA of 3), 23.1% had severe plaque psoriasis of the scalp (ScPGA of 4), 71.6% of subjects were biologic-naïve, and 58.8% had failed 1 or 2 topical treatments. At baseline, the mean Whole Body Itch NRS score was 7.2 and the mean Scalp Itch NRS score was 6.7 with the scales ranging from 0 to 10. The mean baseline SSA involvement was 60.6% and the mean baseline BSA involvement was 19.8%. The proportion of subjects who achieved an ScPGA response, Whole Body Itch NRS response, and Scalp Itch NRS response at Week 16 are presented in Table 9. Figure 1 displays the proportion of subjects achieving Whole Body Itch NRS response at each visit, while Figure 2 displays the proportion of subjects achieving Scalp Itch NRS response at each visit.
Table 9. Efficacy Results at Week 16 in Adults with Plaque Psoriasis of the Scalp in Trial PSOR-3 Trial PSOR-3 Placebo OTEZLA 30 mg twice daily Treatment Difference OTEZLA – Placebo., Adjusted difference in proportions is the weighted average of the treatment differences across baseline ScPGA scores with the Cochran-Mantel-Haenszel weights. (95% CI CI = confidence interval. ) Number of subjects randomized N = 102 N = 201 ScPGA response ScPGA score of clear or almost clear with at least a 2-point reduction from baseline. 13.7% 43.3% 29.6% (19.5%, 39.7%) Number of subjects with baseline Whole Body Itch NRS Score ≥ 4 N = 94 N = 185 Whole Body Itch NRS response 22.5% 45.5% 23.0% (11.5%, 34.6%) Number of subjects with baseline Scalp Itch NRS Score ≥ 4 N = 90 N = 175 Scalp Itch NRS response 21.1% 47.1% 26.2% (13.9%, 38.5%) Figure 1. Proportion (± SE) of Subjects Achieving Whole Body Itch NRS Response through Week 16 NRS = Numeric Rating Scale; SE = standard error Figure 2. Proportion (± SE) of Subjects Achieving Scalp Itch NRS Response through Week 16 NRS = Numeric Rating Scale; SE = standard error Figure 1 Figure 2 Plaque Psoriasis Involving the Genital Area A randomized, double-blind, placebo-controlled trial (PSOR-5 ) was conducted in 289 adult subjects with moderate to severe plaque psoriasis of the genital area. Subjects had a modified static Physician Global Assessment of Genitalia (sPGA-G) score of ≥ 3 (moderate or severe), sPGA score of ≥ 3 (moderate or severe), and had an inadequate response or were intolerant to topical therapy for the treatment of plaque psoriasis of the genital area. Subjects were randomized 1:1 to receive either apremilast 30 mg twice daily (n = 143) or placebo twice daily (n = 146) for 16 weeks.
At Week 16, the placebo group was switched to receive OTEZLA and the OTEZLA group remained on drug through Week 32. The primary endpoint was the proportion of subjects who achieved a modified sPGA-G response (defined as a score of clear or almost clear with at least a 2-point reduction from baseline) at Week 16. Secondary endpoints included the proportion of subjects who achieved an sPGA response (defined as a score of clear or almost clear with at least a 2-point reduction from baseline) at Week 16 and the proportion of subjects who achieved at least a 4-point improvement in the 11-point Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) item score within the Genital Psoriasis Symptoms Scale (GPSS) at Week 16, among subjects with a baseline GPI-NRS score of ≥ 4. Subjects ranged in age from 18-81 years, with a median age of 44 years. The proportions of subjects with a modified sPGA-G score of 3 (moderate) and 4 (severe) at baseline were 86.9% and 13.1%, respectively. The proportions of subjects with a sPGA score of 3 (moderate) and 4 (severe) at baseline were 88.6% and 11.1%, respectively.
Baseline BSA involvement was < 10% for 57.4% of the subjects and ≥ 10% for 42.6% of the subjects. The mean baseline GPI-NRS score was 6.5. Of the enrolled subjects, 78.9% did not receive prior conventional systemic therapy and 84.4% were biologic-naïve. The proportions of subjects who achieved a modified sPGA-G response, sPGA response, and GPI-NRS response are presented in Table 10. Table 10. Efficacy Results at Week 16 in Adults with Plaque Psoriasis of the Genital Area in Trial PSOR-5 Trial PSOR-5 Placebo OTEZLA 30 mg twice daily Treatment Difference OTEZLA – Placebo., Adjusted difference in proportions is the weighted average of the treatment differences across the baseline BSA strata (BSA < 10% or ≥ 10%) with the Cochran-Mantel-Haenszel weights. (95% CI) CI = confidence interval.
Number of Subjects Randomized N = 146 N = 143 Modified sPGA-G Response Modified sPGA-G score of clear or almost clear with at least a 2-point reduction from baseline. The sPGA-G scale was modified from a 6-point to a 5-point scale, ranging from 0 (clear) to 4 (severe), to assess the severity of the 3 primary signs of genital psoriasis: erythema, scaling, and plaque elevation. 19.5% 39.6% 20.1% (9.2%, 30.9%) sPGA Response sPGA score of clear or almost clear with at least a 2-point reduction from baseline. 6.9% 22.2% 15.2% (6.9%, 23.6%) Number of Subjects with Baseline GPI-NRS Score ≥ 4 N = 121 N = 122 GPI-NRS Response GPI-NRS score reduction of ≥ 4-points from baseline. 19.6% 47.3% 27.4% (15.4%, 39.3%)
Pediatric Moderate to Severe Plaque Psoriasis
A multicenter, randomized, double-blind, placebo-controlled trial (PSOR-6 ) was conducted in 245 pediatric subjects 6 to 17 years of age (inclusive) with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy. Subjects had an sPGA score of ≥ 3 (moderate or severe disease), BSA involvement of ≥ 10%, and PASI score of ≥ 12, with psoriasis that was inadequately controlled by or inappropriate for topical therapy. Subjects were allowed to use low potency or weak topical corticosteroids on the face, axilla, and groin and unmedicated skin moisturizers for body lesions only.
Subjects were randomized 2:1 to receive either OTEZLA (n = 163) or placebo (n = 82) for 16 weeks. Subjects with a baseline weight of 20 kg to < 50 kg received OTEZLA 20 mg twice daily or placebo twice daily, and subjects with a baseline weight ≥ 50 kg received OTEZLA 30 mg twice daily or placebo twice daily. At Week 16, the placebo group was switched to receive OTEZLA (with dosage based on baseline weight) and the OTEZLA group remained on drug (according to their original dosing assignment) through Week 52. The primary endpoint was the proportion of subjects who achieved an sPGA response (defined as a score of clear or almost clear with at least a 2-point reduction from baseline) at Week 16. The key secondary endpoint was the proportion of subjects who achieved a PASI-75 response (at least a 75% reduction in PASI score from baseline) at Week 16. Enrolled subjects ranged in age from 6 to 17 years, with a median age of 13 years; 41.2% of subjects were 6 to 11 years of age and 58.8% of subjects were 12 to 17 years of age.
Of the enrolled subjects, 52.2% were female. For race, 86.9% were White, 3.7% were Asian, 3.3% were Black or African American, 0.8% were American Indian or Alaskan Native, and 5.3% were not reported or unknown. For ethnicity, 81.6% of subjects identified as not Hispanic or Latino, 13.1% identified as Hispanic or Latino, and 5.3% were not reported or unknown.
The mean baseline BSA involvement was 31.5% (median 26.0%), the mean baseline PASI score was 19.8 (median 17.2), and the proportions of subjects with an sPGA score of 3 (moderate) and 4 (severe) at baseline were 75.5% and 24.5%, respectively. Of the enrolled subjects, 82.9% did not receive prior conventional systemic therapy and 94.3% were biologic-naïve. Clinical Response in Pediatric Subjects 6 to 17 Years of Age and Weighing at Least 20 kg with Moderate to Severe Plaque Psoriasis The proportions of subjects who achieved sPGA response and PASI-75 response at Week 16 are presented in Table 11. Table 11. Efficacy Results at Week 16 in Pediatric Subjects 6 to 17 Years of Age and Weighing at Least 20 kg with Moderate to Severe Plaque Psoriasis in Trial PSOR-6 Trial PSOR-6 Placebo OTEZLA Subjects weighing ≥ 50 kg received OTEZLA 30 mg twice daily and subjects weighing 20 kg to < 50 kg received OTEZLA 20 mg twice daily.
Treatment Difference OTEZLA – Placebo., Adjusted difference in proportions is the weighted average of the treatment differences across the baseline age strata (6 to 11 years of age or 12 to 17 years of age) with the Cochran-Mantel-Haenszel weights. (95% CI) CI = confidence interval. Number of Subjects Randomized N = 82 N = 163 sPGA Response sPGA score of clear or almost clear with at least a 2-point reduction from baseline. 10.8% 33.1% 22.3% (12.2%, 32.4%) PASI-75 Response At least a 75% reduction in PASI score from baseline. 16.0% 45.7% 29.7% (17.9%, 41.6%)
Adult Mild to Moderate Plaque Psoriasis
A multicenter, randomized, double-blind, placebo-controlled trial (PSOR-4 ) was conducted in 595 adult subjects with mild to moderate plaque psoriasis (BSA involvement of 2-15%, sPGA score of 2-3, and PASI score of 2-15). Enrolled subjects had an inadequate response or were intolerant to at least one topical therapy and had not received prior biologic therapy. Subjects were allowed to use unmedicated emollients for lesions on non-scalp areas of the body and non-medicated shampoos for lesions on the scalp. Subjects were randomized 1:1 to receive either OTEZLA 30 mg twice daily (n = 297) or placebo twice daily (n = 298) for 16 weeks.
At Week 16, the placebo group was switched to receive OTEZLA and the OTEZLA group remained on drug through Week 32. The primary endpoint was the proportion of subjects who achieved an sPGA response (defined as an sPGA score of clear or almost clear with at least a 2-point reduction from baseline) at Week 16. Subjects with mild disease (sPGA = 2 at baseline) were required to be clear (sPGA = 0) to achieve an sPGA response. Other evaluated endpoints include the proportion of subjects with a Whole Body Itch NRS response (defined as a ≥ 4-point reduction from baseline) at Week 16 among subjects with a baseline Whole Body Itch NRS ≥ 4 and the proportion of subjects with an ScPGA response (defined as an ScPGA score of clear or almost clear with at least a 2-point reduction from baseline) at Week 16 among subjects with a baseline ScPGA score ≥ 2. Subjects ranged in age from 18 to 85 years, with an overall median age of 50 years. The mean baseline BSA involvement was 6.4%, the mean baseline PASI score was 6.5, and the proportions of subjects with an sPGA score of 2 (mild) and 3 (moderate) at baseline were 30.6% and 69.4%, respectively.
Clinical Response in Subjects with Mild to Moderate Plaque Psoriasis The proportions of subjects who achieved an sPGA response, Whole Body Itch NRS response, and an ScPGA response at Week 16 are presented in Table 12. Table 12. Efficacy Results at Week 16 in Adults with Mild to Moderate Plaque Psoriasis in Trial PSOR-4 Trial PSOR-4 Placebo OTEZLA 30 mg twice daily Treatment Difference OTEZLA – Placebo., Adjusted difference in proportions is the weighted average of the treatment differences across baseline sPGA scores with the Cochran-Mantel-Haenszel weights. (95% CI CI = confidence interval. ) Number of Subjects Randomized N = 298 N = 297 sPGA Response sPGA score of clear or almost clear with at least a 2-point reduction from baseline. 4.1% 21.6% 17.5% (12.2%, 22.8%) Number of Subjects with Baseline Whole Body Itch NRS Score ≥ 4 N = 249 N = 253 Whole Body Itch NRS Response Whole Body Itch NRS score reduction of ≥ 4-points from baseline. 18.6% 43.2% 24.7% (16.5%, 32.8%) Number of Subjects with Baseline ScPGA Score ≥ 2 N = 199 N = 212 ScPGA Response ScPGA score of clear or almost clear with at least a 2-point reduction from baseline. 16.6% 44.0% 27.4% (18.6%, 36.3%)
Adult Oral Ulcers Associated with Behçet's Disease
A multicenter, randomized, placebo-controlled trial (BCT-002 ) enrolled a total of 207 adult subjects with BD with active oral ulcers. Subjects were previously treated with at least one nonbiologic BD medication and were candidates for systemic therapy. Subjects met the International Study Group (ISG) Criteria for BD. Subjects had at least 2 oral ulcers at screening and at least 2 oral ulcers at randomization and without currently active major organ involvement.
Concomitant treatment for BD was not allowed. Subjects were randomized 1:1 to receive either OTEZLA 30 mg twice daily (n = 104) or placebo (n = 103) for 12 weeks. After Week 12, all subjects received OTEZLA 30 mg twice daily.
Efficacy was assessed based on the number and pain of oral ulcers. Subjects ranged in age from 19 to 72 years, with a mean age of 40 years. The mean duration of BD was 6.84 years.
All subjects had a history of recurrent oral ulcers that were currently active. Subjects had a history of skin lesions (98.6%), genital ulcers (90.3%), musculoskeletal manifestations (72.5%), ocular manifestations (17.4%), central nervous system (9.7%), gastrointestinal (GI) manifestations (9.2%) and vascular involvement (1.4%). The mean baseline oral ulcer counts were 4.2 and 3.9 in the OTEZLA and placebo groups, respectively. Measures of Oral Ulcers Improvements in measures of oral ulcers at Week 12 are presented in Table 13. Table 13. Clinical Response of Oral Ulcers at Week 12 in Adult Subjects with BD in the BCT-002 Trial (ITT ITT = intent to treat.
Population) Endpoint Placebo N = 103 OTEZLA 30 mg twice daily N = 104 Treatment Difference OTEZLA – Placebo. (95% CI CI = confidence interval. ) Change Mean changes from baseline are least square means from mixed effects-model for repeated measures, adjusting for sex, region, and baseline pain of oral ulcers as measured by the visual analog scale. from baseline in the pain of oral ulcers as measured by VAS VAS = visual analog scale; 0 = no pain, 100 = worst possible pain. at Week 12 −18.7 −42.7 −24.1 (−32.4, −15.7) Proportion Subjects for whom data are not available to determine response status are considered non-responders. of subjects achieving oral ulcer complete response (oral ulcer-free) at Week 12 22.3% 52.9% 30.6% Adjusted difference in proportions is the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the Cochran-Mantel-Haenszel weights. (18.1%, 43.1%) Proportion of subjects achieving oral ulcer complete response (oral ulcer-free) by Week 6, and who remained oral ulcer-free for at least 6 additional weeks during the 12-week Placebo-controlled Treatment Phase 4.9% 29.8% 25.1% (15.5%, 34.6%) Daily average Mean daily averages are least squares means from analysis of covariance, after adjusting for sex, region, and baseline number of oral ulcers., Based on oral ulcer counts measured at baseline and at Weeks 1, 2, 4, 6, 8, 10, and 12. number of oral ulcers during the 12-week Placebo-controlled Treatment Phase 2.6 1.5 −1.1 (−1.6, −0.7) Figure 3 displays the mean number of oral ulcers for each treatment group at each visit, while Figure 4 displays the mean oral ulcer pain on a visual analog scale for each treatment group at each visit. Figure 3. Mean (± SE) Number of Oral Ulcers by Time Point Through Week 12 (ITT Population) Weeks 0 1 2 4 6 8 10 12 ITT = intent-to-treat; SE = standard error Placebo, n 103 98 97 93 91 86 83 82 OTEZLA 30 mg twice daily, n 104 101 101 101 98 94 94 97 Figure 4. Mean (± SE) Oral Ulcer Pain on a Visual Analog Scale by Time Point Through Week 12 (ITT Population) Weeks 0 1 2 4 6 8 10 12 ITT = intent to treat; SE = standard error. Oral ulcer pain was assessed on a 100-mm Visual Analog Scale with 0 = no pain and 100 = worst possible pain.
Mean baseline Visual Analog Scale pain scores were 61.2 and 60.8 in the OTEZLA 30 mg twice daily treatment group and placebo treatment group, respectively. Placebo, n 101 95 96 91 90 85 82 81 OTEZLA 30 mg twice daily, n 102 95 97 99 97 92 93 95 Figure 3 Figure 4
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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