Ianalumab in moderate-to-severe SLE: Phase II end-of-study results

Results from a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study (NCT03656562) evaluating ianalumab 300 mg subcutaneous (SC) every 4 weeks (QW4; n = 34) vs placebo (n = 33) in patients with moderate-to-severe systemic lupus erythematosus (SLE) were presented by Edward M. Vital at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, June 3–6, 2026, London, UK. Clinical outcomes at the end of study (EoS) after B-cell recovery were assessed.

Key data: At Week 28, a greater proportion of patients receiving ianalumab vs placebo achieved SLE Responder Index-4 (SRI-4; 44.1% vs 9.1%), Lupus Low Disease Activity State (LLDAS; 17.6% vs 9.1%), and Definition of Remission in SLE (DORIS; 11.8% vs 3.0%). Response rates continued to increase over the open-label period (Weeks 29–52) in patients who continued ianalumab and those who switched from placebo to ianalumab for SRI-4 (45.5% and 40.6%), LLDAS (39.4% and 21.9%), and DORIS (27.3% and 12.5%). With a median time after end of treatment (EoT) of 44 weeks, efficacy persisted off treatment until B-cell recovery (LLDAS, 32.4% and 24.2%; DORIS, 26.5% and 15.2%). No new safety signals were identified, and no serious adverse events (SAEs) were considered related to ianalumab.

Key learning: Prolonged ianalumab therapy up to 1 year was associated with increased response rates in patients with SLE, with clinical benefits persisting following B-cell recovery, suggesting that long-term treatment with ianalumab provides durable clinical benefits. These findings warrant confirmation in larger clinical trials.