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The Safety Profile of SAPHNELO in SLE Was Evaluated in 3 Clinical Trials Involving 925 Adults
The safety of anifrolumab was evaluated through 52 weeks in patients with moderate to severe, active SLE who received 300 mg by IV infusion every 4 weeks (N=459) compared to placebo (N=466) in 3 controlled clinical trials (TULIP 1, TULIP 2 and MUSE).1*†‡
The most commonly reported adverse events (≥5%) during anifrolumab treatment, irrespective of causality, were nasopharyngitis (16.3%, placebo: 9.4%), upper respiratory tract infection (15.5%, placebo: 9.7%), urinary tract infection (12.0%, placebo: 13.5%), bronchitis (9.8%, placebo: 4.3%), infusion-related reaction (9.4%, placebo: 7.1%), headache (8.1%, placebo: 9.7%), herpes zoster (6.1%, placebo: 1.3%), back pain (5.2%, placebo: 4.3%), sinusitis (5.2%, placebo: 5.2%) and cough (5.0%, placebo: 3.2%).
The Safety Profile of SAPHNELO in SLE Was Evaluated in a Follow-up Long-term Extension Study (LTE)§
Patients who completed TULIP 1 and TULIP 2 (Phase 3 feeder trials) through Week 52 were eligible to continue on treatment in a randomized, double-blind, placebo-controlled LTE for an additional 3 years. The long-term safety of anifrolumab was assessed in 257 patients who received anifrolumab 300 mg administered by intravenous infusion once every 4 weeks, compared to 112 patients who received placebo, in both a feeder trial and the LTE. Of these, 177 patients who received anifrolumab (68.9%) and 52 patients who received placebo (46.4%) completed a total of 4 years on treatment.
The overall long-term safety profile of anifrolumab was consistent with the 52-week trials.
IV=intravenous therapy; SLE=systemic lupus erythematosus.
* TULIP 1 was a 52-week treatment period, Phase 3, multicentre, randomized, double-blind, placebo-controlled study. A total of 457 patients were randomized (1:2:2) and received anifrolumab 150 mg (not a recommended dose of SAPHNELO) (n=93) or 300 mg (n=180), or placebo (n=184) via intravenous infusion every 4 weeks for 52 weeks (13 doses).
† TULIP 2 was a 52-week treatment period, Phase 3, multicentre, randomized, double-blind, placebo-controlled study. A total of 362 patients were randomized (1:1) and received anifrolumab 300 mg (n=180) or placebo (n=182) via intravenous infusion every 4 weeks for 52 weeks (13 doses).
‡ MUSE was a 52-week, Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicentre study of 305 adult patients with moderately to severely active, autoantibody positive SLE who were randomized 1:1:1 to receive anifrolumab 300 mg (n=99), anifrolumab 1000 mg (not a recommended dose of SAPHNELO) (n=104), or placebo (n=102) via intravenous infusion every 4 weeks for 52 weeks (13 doses).
§ Patients who completed TULIP 1 and TULIP 2 (feeder trials) were eligible to continue on treatment in a randomized, double-blind, placebo-controlled, 3-year long-term extension study (LTE). Patients who had received anifrolumab, either 150 mg or 300 mg, in TULIP 1 and TULIP 2 received anifrolumab 300 mg in the LTE. Patients who had received placebo in TULIP 1 and TULIP 2 were re-randomized 1:1 to receive either anifrolumab 300 mg or placebo, giving an approximate anifrolumab 300 mg: placebo ratio of 4:1 in the LTE.
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