Saphnelo Drug Information
Generic name: ANIFROLUMAB-FNIA
Type I Interferon Receptor Antagonist [EPC]
Uses of Saphnelo
SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.
Dosage & Administration of Saphnelo
Important Administration Information SAPHNELO is intended for use under the guidance of a healthcare provider and may be administered as an intravenous infusion or as a subcutaneous injection. SAPHNELO vials are for intravenous use only and must be diluted prior to intravenous administration. SAPHNELO prefilled syringe and autoinjector (SAPHNELO PEN) are for subcutaneous use only.
Recommended Dosage
The recommended dosage of SAPHNELO is: • 300 mg, administered as an intravenous infusion over a 30‑minute period every 4 weeks; or • 120 mg, administered as a subcutaneous injection once every week. Missed Dose If a planned intravenous infusion is missed, administer SAPHNELO as soon as possible. Maintain a minimum interval of 14 days between infusions.
If a planned subcutaneous dose is missed, instruct the patient to administer SAPHNELO as soon as they remember. Thereafter, instruct the patient to start a new weekly schedule from the day the missed dose was administered or resume dosing on their usual day of administration, providing a minimum interval of 3 days between subcutaneous injections.
Intravenous Preparation and Administration Instructions SAPHNELO is supplied as a single-dose vial. Prepare the diluted infusion solution using aseptic technique, by the following procedure: 1. Visually inspect the vial for particulate matter and discoloration.
SAPHNELO is a clear to opalescent, colorless to slightly yellow, solution. Discard the vial if the solution is cloudy, discolored or visible particles are observed. Do not shake the vial. 2.
Withdraw 2 mL of solution from the vial of SAPHNELO and add it to the infusion bag. Mix the solution by gentle inversion. Do not shake. 4.
Each vial is intended for one time use only. Discard any unused portion remaining in the vial. 5. Administer the infusion solution immediately after preparation. 6.
If the infusion solution is not administered immediately, store the diluted solution of SAPHNELO at room temperature 59°F to 77°F (15°C to 25°C) for up to 4 hours, or refrigerated 36°F to 46°F (2°C to 8°C) for up to 24 hours. Do not freeze. Protect from light.
If refrigerated, allow the diluted SAPHNELO solution to reach room temperature prior to administration. 7. Administer the infusion solution intravenously over a 30-minute period through an infusion line containing a sterile, low-protein binding 0.2 to 15 micron in-line or add-on filter. 8. To ensure the complete dose of SAPHNELO has been administered, flush the entire infusion line with 25 mL of 0.9% Sodium Chloride Injection, USP at the end of the infusion. 9.
Do not co-administer other medicinal products through the same infusion line. 10. Dispose of any unused medicinal product or waste material in accordance with local requirements.
Comprehensive instructions for subcutaneous administration of SAPHNELO using the prefilled syringe or autoinjector are provided in the ‘Instructions for Use’. 2. Patients/caregivers may administer SAPHNELO prefilled syringe/SAPHNELO PEN after proper training in the subcutaneous injection technique and after the healthcare provider determines it is appropriate. 3. Prior to administration, remove SAPHNELO from the refrigerator and allow it to come to room temperature for 60 minutes. 4.
Visually inspect SAPHNELO for particulate matter and discoloration prior to administration. Administer the subcutaneous injection into the thigh or abdomen, avoiding the 5 cm (approximately 2 inches) area around the navel. The upper arm can also be used if a healthcare professional or caregiver administers the injection. 6.
Do not inject into areas where the skin is tender, bruised, erythematous or hardened. When injecting in the same region, advise patients to use an injection site at least 3 cm (1‑inch) away from the last injection site. 7.
Switching Between Intravenous and Subcutaneous Administration When transitioning patients from intravenous administration to subcutaneous administration of SAPHNELO, administer the first subcutaneous injection approximately 2 weeks after the last intravenous infusion.
Side Effects of Saphnelo
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 practice. In the controlled-clinical trials, adverse reactions, irrespective of causality, were reported in 87% of patients receiving SAPHNELO and 79% of patients receiving placebo. Adverse reactions that occurred at greater than or equal to 2% incidence are shown in Table 1.
The overall long-term safety profile of SAPHNELO was consistent with Trials 1, 2 and 3. Specific Adverse Reactions Infections: In the 52‑week controlled-clinical trials, infections were reported in a greater proportion of patients while on treatment with SAPHNELO compared to placebo (69.7% versus 55.4%, respectively). Herpes Zoster: In the 52‑week controlled-clinical trials, the incidence of herpes zoster in patients while on treatment with SAPHNELO was 6.1% and 1.3% in patients on placebo.
Cases with multidermatomal involvement and disseminated presentation have been reported. Of the 28 SAPHNELO-treated patients with herpes zoster, 2 experienced disseminated disease requiring hospitalization compared to none among placebo-treated patients. Hypersensitivity Reactions Including Anaphylaxis: During the SLE intravenous development program, there was one report of an anaphylactic reaction in a patient who received SAPHNELO 150 mg, and 4 reports of angioedema after 300 mg.
In general, the hypersensitivity reactions were predominantly mild or moderate in intensity and did not lead to discontinuation of SAPHNELO. In the 52‑week controlled‑clinical trials, hypersensitivity reactions occurred in 2.8% of patients while on treatment with SAPHNELO and 0.6% of patients on placebo. Serious hypersensitivity reactions were reported in 0.6% of patients receiving SAPHNELO, including angioedema (n=2).
Infusion‑related Reactions: Infusion‑related reactions were mild to moderate in intensity; the most common symptoms were headache, nausea, vomiting, fatigue, and dizziness. In the 52‑week controlled‑clinical trials, the incidence of infusion‑related reactions while on treatment was 9.4% in patients while on treatment with SAPHNELO and 7.1% in patients on placebo. Malignancies: In 52‑week controlled-clinical trials, malignancies (excluding non‑melanoma skin cancers) were observed in 0.7% and 0.6% of SAPHNELO-treated and placebo-treated patients.
Malignant neoplasm (including non‑melanoma skin cancers) was reported in 1.3% of SAPHNELO-treated patients, compared to 0.6% placebo-treated patients. The malignancies that were reported in more than one patient treated with SAPHNELO included breast cancer and squamous cell carcinoma. Adverse Reactions with Subcutaneous Administration The safety profile of SAPHNELO administered subcutaneously in adult patients with moderate to severe SLE is derived from Trial 5.
The data reflect SAPHNELO exposure in 185 patients who received SAPHNELO 120 mg by subcutaneous injection once every week, with a median duration of 52 weeks, as compared with comparable exposure to placebo in 182 patients. All patients received standard therapy. The safety profile observed for SAPHNELO administered subcutaneously was consistent with the known safety profile of SAPHNELO administered intravenously.
Serious Infections in the Pool of Intravenous and Subcutaneous Trials In the pool of four placebo-controlled clinical trials in adults with moderate to severe SLE where SAPHNELO was administered either intravenously or subcutaneously Trials the incidence of serious infections while on treatment was 5.4% in patients treated with SAPHNELO compared to 4.9% in patients receiving placebo. Fatal infections occurred while on treatment in 0.5% of SAPHNELO-treated patients and 0% in placebo-treated patients. The most frequent serious infection reported in patients treated with SAPHNELO was pneumonia.
During the LTE of Trials 2 and 3, the most common serious infections were COVID‑19 and pneumonia.
Postmarketing Experience
The following adverse reaction has been identified during post-approval use of SAPHNELO. Because the 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. Arthralgia
| Adverse Reaction | SAPHNELO (N=459) % | Placebo (N=466) % |
|---|---|---|
| Upper respiratory tract infection Upper respiratory tract infections (including Upper respiratory tract infections, Nasopharyngitis, Pharyngitis) | 34 | 23 |
| Bronchitis Bronchitis (including Bronchitis, Bronchitis viral, Tracheobronchitis) | 11 | 5.2 |
| Infusion‑related reactions | 9.4 | 7.1 |
| Herpes Zoster | 6.1 | 1.3 |
| Cough | 5.0 | 3.2 |
| Respiratory tract infection Respiratory tract infection (including Respiratory tract infection, Respiratory tract infection viral, Respiratory tract infection bacterial) | 3.3 | 1.5 |
| Hypersensitivity | 2.8 | 0.6 |
| All patients received standard therapy. | ||
Warnings & Cautions for Saphnelo
Serious Infections Serious and sometimes fatal infections (including COVID‑19) have occurred in patients receiving immunosuppressive agents, including SAPHNELO. In controlled trials, fatal infections occurred more frequently in patients receiving SAPHNELO. In controlled trials, SAPHNELO increased the risk of respiratory infections and herpes zoster (disseminated herpes zoster events have been reported).
Avoid initiating treatment with SAPHNELO in patients with any clinically significant active infection until the infection is resolved or adequately treated. Consider the benefit and risk of administering SAPHNELO in patients with a chronic infection, a history of recurrent infections, or known risk factors for infection. Instruct patients to seek medical advice if signs or symptoms of a clinically significant infection occur.
If a patient develops an infection or is not responding to standard anti-infective therapy while on SAPHNELO, monitor the patient closely and consider interrupting SAPHNELO until the infection resolves.
Hypersensitivity Reactions Including Anaphylaxis
Serious hypersensitivity reactions (including anaphylaxis) have been reported following SAPHNELO administration. Events of angioedema have also been reported. Other hypersensitivity reactions and infusion-related reactions have occurred following administration of SAPHNELO.
Consider pre-medication before infusion of SAPHNELO for patients with a history of these reactions. SAPHNELO should be administered by healthcare providers prepared to manage hypersensitivity reactions, including anaphylaxis, and infusion-related reactions. If a serious infusion-related or hypersensitivity reaction (e.g., anaphylaxis) occurs, immediately interrupt the administration of SAPHNELO and initiate appropriate therapy.
Malignancy There is an increased risk of malignancies with the use of immunosuppressants. The impact of SAPHNELO treatment on the potential development of malignancies is not known. Consider the individual benefit-risk in patients with known risk factors for the development or reoccurrence of malignancy prior to prescribing SAPHNELO.
In patients who develop malignancies, consider the benefit-risk of continued treatment with SAPHNELO.
Immunizations
Update immunizations, according to current immunization guidelines, prior to initiating SAPHNELO therapy. Avoid concurrent use of live or live-attenuated vaccines in patients treated with SAPHNELO.
Not Recommended for Concomitant Use with Other Biologic Therapies SAPHNELO has not been studied in combination with other biologic therapies, including B-cell-targeted therapies. Therefore, use of SAPHNELO is not recommended for use in combination with biologic therapies.
Drug Interactions with Saphnelo
No formal drug interaction trials have been conducted.
Pregnancy Safety for Saphnelo
Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. For more information about the registry or to report a pregnancy while on SAPHNELO, healthcare providers should contact AstraZeneca at 1‑877‑693‑9268 or https://anifrolumabpregnancyandbreastfeedingstudy.us/. Risk Summary The limited human data with SAPHNELO use in pregnant women are insufficient to inform on drug‑associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome.
Monoclonal IgG antibodies are known to be actively transported across the placenta as pregnancy progresses; therefore, anifrolumab‑fnia exposure to the fetus may be greater during the third trimester of pregnancy. In an enhanced pre- and post-natal development study with pregnant cynomolgus monkeys that received intravenous administration of anifrolumab-fnia, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28‑times the exposure at the maximum recommended human dose (MRHD) on an Area Under Curve (AUC) basis (see Data ). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Pregnant women with SLE are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction.
Maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block. Data Animal Data: In an enhanced pre- and post-natal development study, pregnant cynomolgus monkeys received anifrolumab-fnia at intravenous doses of 30 or 60 mg/kg once every 2 weeks from confirmation of pregnancy at Gestation Day 20, throughout the gestation period, and continuing until 1‑month post-partum (approximately Lactation Day 28).
There was no evidence of anifrolumab-fnia related maternal toxicity, embryo-fetal toxicity, or post-natal developmental effects. No anifrolumab-fnia related effect on T-cell-dependent antibody response in the infants was noted up to Day 180 after birth. The no observed adverse effect level (NOAEL) for maternal and developmental toxicity was identified as 60 mg/kg (approximately 28‑times the MRHD on an AUC basis).
In the infants, mean serum concentrations of anifrolumab‑fnia on Day 30 after birth increased with dose and were approximately 4.2% to 9.7% of the respective maternal concentrations. The anifrolumab-fnia concentrations in the infant serum were up to approximately 22‑times the concentrations in the maternal milk, suggesting that anifrolumab-fnia had transferred via the placenta.
Pediatric Use of Saphnelo
Pediatric Use The safety and efficacy of SAPHNELO in pediatric patients have not been established.
Contraindications for Saphnelo
SAPHNELO is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia.
Clinical Studies of Saphnelo
Intravenous Administration in Adults with Moderate to Severe SLE Trial Design and Population The safety and efficacy of SAPHNELO were evaluated in three 52-week treatment period, multicenter, randomized, double-blind, placebo-controlled trials (Trial 1, Trial 2 and Trial 3 ). Patients were diagnosed with SLE according to the American College of Rheumatology (1982 revised) classification criteria. All patients were ≥18 years of age and had moderate to severe disease, with a SLE Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points, organ level involvement based on the British Isles Lupus Assessment Group (BILAG) assessment, and a Physician’s Global Assessment score ≥1, despite receiving standard SLE therapy consisting of either one or any combination of oral corticosteroids (OCS), antimalarials and/or immunosuppressants at baseline.
Patients continued to receive their existing SLE therapy at stable doses during the clinical trials, with the exception of OCS (prednisone or equivalent) where tapering was a component of the protocol. Patients who had severe active lupus nephritis and patients who had severe active central nervous system lupus were excluded. The use of other biologic agents and cyclophosphamide were not permitted during the trials; patients receiving other biologic therapies were required to complete a wash-out period of at least 5 half‑lives prior to enrollment.
All three trials were conducted in North America, Europe, South America and Asia. Patients received SAPHNELO or placebo, administered by intravenous infusion, every 4 weeks. Efficacy of SAPHNELO was established based on assessment of clinical response using the composite endpoints, the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) and the SLE Responder Index (SRI‑4).
BICLA response at Week 52, was defined as improvement in all organ domains with moderate or severe activity at baseline: • Reduction of all baseline BILAG A to B/C/D and baseline BILAG B to C/D, and no BILAG worsening in other organ systems, as defined by ≥1 new BILAG A or ≥2 new BILAG B; • No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of >0 points in SLEDAI-2K; • No worsening from baseline in patients’ lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point PGA visual analogue scale (VAS); • No discontinuation of treatment; • No use of restricted medication beyond the protocol-allowed threshold. SRI‑4 response, was defined as meeting each of the following criteria at Week 52 compared with baseline: • Reduction from baseline of ≥4 points in the SLEDAI-2K; • No new organ system affected as defined by 1 or more BILAG A or 2 or more BILAG B items compared to baseline; • No worsening from baseline in the patients’ lupus disease activity defined by an increase ≥0.30 points on a 3‑point PGA VAS; • No discontinuation of treatment; • No use of restricted medication beyond the protocol-allowed threshold. Trial 2 and 3 were similar in design.
The primary endpoints were improvement in disease activity evaluated at 52 weeks, measured by SRI‑4 in Trial 2 and BICLA in Trial 3 (defined above). The common secondary efficacy endpoints included in both trials were the maintenance of OCS reduction, improvement in cutaneous SLE activity, and flare rate. During Weeks 8-40, patients with a baseline OCS ≥10 mg/day were required to taper their OCS dose to ≤7.5 mg/day, unless there was worsening of disease activity.
Patient demographics and disease characteristics were generally similar and balanced across treatment arms (Table 2). Table 2 Demographics and Baseline Characteristics of Adults with Moderate to Severe SLE in Trials Randomization was stratified by disease severity (SLEDAI-2K score at baseline, <10 vs ≥10 points), OCS dose on Day 1 (<10 mg/day vs ≥10 mg/day prednisone or equivalent) and interferon gene signature test results (high vs low). The reduction in disease activity seen in the BICLA and SRI-4 was related primarily to improvement in the mucocutaneous and musculoskeletal organ systems.
Flare rate was reduced in SAPHNELO patients compared to placebo patients although the difference was not statistically significant. BICLA responder analysis BICLA was the primary endpoint in Trial 3, SAPHNELO 300 mg once every 4 weeks demonstrated statistically significant and clinically meaningful efficacy in overall disease activity compared with placebo, with greater improvements in all components of the composite endpoint. In Trial 1 and 2, BICLA was a pre-specified analysis.
The BICLA results are presented in Table 3. Table 3 BICLA Response Rate at Week 52 in Adults with Moderate to Severe SLE in Trials 1, 2, and 3, examination of subgroups by age, race, gender, ethnicity, disease severity, and baseline OCS use did not identify differences in response to SAPHNELO. Figure 1 shows the proportion of BICLA responders through the 52-week treatment period in Trial 3.
Figure 1 Trial 3: Proportion (%) of BICLA Responders in Adults with Moderate to Severe SLE by Visit* SRI-4 responder analysis SRI-4 was the primary endpoint in Trial 2, treatment with SAPHNELO did not result in statistically significant improvements over placebo. In Trials 1 and 3, SRI-4 was a pre-specified analysis. The SRI-4 results are presented in Table 4.
Consistent trends in favor of SAPHNELO compared to placebo, on effect of reduction of OCS use, were observed in Trial 1 and 2, but the difference was not statistically significant. figure_1
Subcutaneous Administration in Adults with Moderate to Severe SLE The safety and efficacy of SAPHNELO administered subcutaneously were evaluated in a 52-week treatment period, multicenter, randomized, double-blind, placebo-controlled trial (Trial 5 ). Patients were randomized (1:1) to receive SAPHNELO 120 mg plus standard therapy or placebo plus standard therapy by subcutaneous injection once every week. A pre-specified interim analysis was conducted when the first 220 randomized patients completed Week 52 or had withdrawn from the trial.
The mean age was 43 years. The primary endpoint was BICLA response rate measured at Week 52. At the interim analysis, SAPHNELO by subcutaneous administration demonstrated a statistically significant and clinically meaningful reduction of overall disease activity compared with placebo (Table 5).
| Total Population | |||
| Trial 1 (N=305) | Trial 2 (N=457) | Trial 3 (N=362) | |
| Mean Age (years) | 40 | 41 | 42 |
| Female (%) | 93 | 92 | 93 |
| White (%) | 42 | 71 | 60 |
| Black/African American (%) | 13 | 14 | 12 |
| Asian (%) | 7 | 5 | 17 |
| Hispanic or Latino (%) | 42 | 19 | 30 |
| Baseline SLEDAI-2K score | |||
| Mean (SD) | 10.9 (4.1) | 11.3 (3.72) | 11.5 (3.76) |
| ≥10 points, n (%) | 182 (60) | 328 (72) | 260 (72) |
| BILAG organ system scoring (Overall) | |||
| At least one A, n (%) | 152 (50) | 217 (48) | 176 (49) |
| No A and at least 2 Bs, n (%) | 134 (44) | 211 (46) | 169 (47) |
| Positive Anti-dsDNA levels, n (%) | 185 (77) | 207 (45) | 159 (44) |
| Abnormal ANA, n (%) | 299 (98) | 412 (90) | 325 (90) |
| Abnormal Complement C3 level, n (%) | 119 (39) | 157 (34) | 144 (40) |
| Abnormal Complement C4 level, n (%) | 74 (24) | 95 (21) | 95 (26) |
| Baseline SLE treatment | |||
| OCS, n (%) | 258 (85) | 381 (83) | 292 (81) |
| Antimalarials, n (%) | 219 (72) | 334 (73) | 252 (70) |
| Immunosuppressants, n (%) | 150 (49) | 214 (47) | 174 (48) |
| Trial 1 Not formally tested in a pre-specified testing scheme and findings should be interpreted with caution. Based on post hoc analysis. | Trial 2 | Trial 3 Primary endpoint. | ||||
|---|---|---|---|---|---|---|
| SAPHNELO 300 mg once every 4 weeks (N=99) | Placebo (N=102) | SAPHNELO 300 mg once every 4 weeks (N=180) | Placebo (N=184) | SAPHNELO 300 mg once every 4 weeks (N=180) | Placebo (N=182) | |
| BICLA Response Rate In all 3 trials, patients who discontinued investigational product or initiated restricted medications beyond the protocol-specified thresholds are considered non-responders. For consistency, the results presented for Trial 2 represent the post-hoc analysis using the restricted medication thresholds as defined in Trial 3. | ||||||
| Responder, n (%) | 54 (54.6) | 27 (25.8) | 85 (47.1) | 55 (30.2) | 86 (47.8) | 57 (31.5) |
| Difference in Response Rates (95% CI) | 28.8 (15.7, 41.9) | 17.0 (7.2, 26.8) | 16.3 (6.3, 26.3) p-value=0.001 | |||
| Components of BICLA Response | ||||||
| BILAG Improvement, n (%) | 54 (54.5) | 28 (27.5) | 85 (47.2) | 58 (31.5) | 88 (48.9) | 59 (32.4) |
| No Worsening of SLEDAI-2K, n (%) | 73 (73.7) | 61 (59.8) | 121 (67.2) | 104 (56.5) | 122 (67.8) | 94 (51.6) |
| No Worsening of PGA, n (%) | 76 (76.8) | 62 (60.8) | 117 (65.0) | 105 (57.1) | 122 (67.8) | 95 (52.2) |
| The response rates and associated difference and 95% CI are calculated using a Cochran-Mantel-Haenszel approach adjusted for stratification factors. The reported percentages for the components are unadjusted. | ||||||
| Trial 1 Not formally tested in a pre-specified testing scheme and findings should be interpreted with caution. | Trial 2 Primary endpoint. | Trial 3 | ||||
|---|---|---|---|---|---|---|
| SAPHNELO 300 mg once every 4 weeks (N=99) | Placebo (N=102) | SAPHNELO 300 mg once every 4 weeks (N=180) | Placebo (N=184) | SAPHNELO 300 mg once every 4 weeks (N=180) | Placebo (N=182) | |
| SRI-4 Response Rate In all 3 trials, patients who discontinued investigational product or initiated restricted medications beyond the protocol-specified thresholds are considered non-responders. For consistency, the results presented for Trial 2 represent the post-hoc analysis using the restricted medication thresholds as defined in Trial 3. The most commonly involved SLEDAI-2K organ domains were mucocutaneous, musculoskeletal and immune. | ||||||
| Responder, n (%) | 62 (62.8) | 41 (38.8) | 88 (49.0) | 79 (43.0) | 100 (55.5) | 68 (37.3) |
| Difference in Response Rates (95% CI) | 24.0 (10.9, 37.2) | 6.0 (-4.2, 16.2) | 18.2 (8.1, 28.3) | |||
| Components of SRI-4 Response | ||||||
| SLEDAI-2K improvement, n (%) | 62 (62.6) | 41 (40.2) | 89 (49.4) | 80 (43.5) | 101 (56.1) | 71 (39.0) |
| No worsening of BILAG, n (%) | 75 (75.8) | 61 (59.8) | 119 (66.1) | 105 (57.1) | 125 (69.4) | 94 (51.6) |
| No worsening of PGA, n (%) | 76 (76.8) | 62 (60.8) | 117 (65.0) | 105 (57.1) | 122 (67.8) | 95 (52.2) |
| The response rates and associated difference and 95% CI are calculated using a Cochran-Mantel-Haenszel approach adjusted for stratification factors. The reported percentages for the components are unadjusted. | ||||||
| SAPHNELO 120 mg once weekly (N=109) | Placebo (N=111) | |
|---|---|---|
| BICLA Response | ||
| Responder, n (%) Per protocol, patients who used restricted medications beyond the protocol-specified thresholds, discontinued investigational product or died were considered non-responders. | 64 (58.5) | 48 (43.2) |
| Difference in Response Rates, % (95% CI) | 15.3 (2.1, 28.5) p-value=0.0231 Based on an interim analysis using Pocock alpha spending function with an information fraction of 0.6. The primary endpoint was tested at the alpha level of 0.0354 at the interim analysis. | |
| Components of BICLA Response | ||
| BILAG Improvement, n (%) | 64 (58.5) | 48 (43.3) |
| No Worsening of SLEDAI-2K, n (%) | 80 (73.4) | 77 (68.9) |
| No Worsening of PGA, n (%) | 80 (73.5) | 78 (70.0) |
| The response rates, associated difference, and 95% CI are calculated using a Cochran-Mantel-Haenszel approach adjusted for stratification factors. | ||
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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