SLE (systemic lupus erythematosus) is one of the chronic autoimmune diseases that affects several organ systems. For a study, researchers sought to determine if anifrolumab could reduce organ-domain-specific SLE disease activity. Data from the phase 3 TULIP-1 (NCT02446912) and TULIP-2 (NCT02446899) studies of anifrolumab (300 mg intravenously once every four weeks for 48 weeks) in patients aged 18–70 with moderate-to-severe SLE were pooled in this post-hoc analysis. Researchers looked at changes in BILAG-2004 and SLE Disease Activity Index 2000 (SLEDAI-2K) organ domain scores, serology, Cutaneous Lupus Erythematosus Disease Area, and Severity Index activity score (CLASI-A), swollen and tender joint counts, and hematology, from baseline to week 52.
The average age of the 726 patients was 418 years (SD 119); 479 (66%) were White, 52 (7%) were male, and 674 (93%) were female. About 360 participants were given 300 mg of anifrolumab (180 patients in each trial), while 366 were given a placebo (182 patients in TULIP-2 and 184 patients in TULIP-1 ). The most frequently affected organ domains at baseline were the patients of musculoskeletal (645 [89%] based on 684 [94%] with SLEDAI-2K; BILAG-2004). Apart from that it had mucocutaneous (699 [96%] based on SLEDAI-2K; 627 [86%] with BILAG-2004) . At week 52, anifrolumab treatment resulted in greater improvements vs placebo in the musculoskeletal system (176 [56%] of 317 patients vs 143 [44%] of 328 with BILAG-2004; 190 [55%] of 348 vs 138 [39%] of 351 SLEDAI-2K); 164 [49%] of 335 vs 141 [40%] of 349 with SLEDAI-2K), the mucocutaneous system (168 [54%] of 315 vs 119 [38%] of 312 with BILAG-2004, and immunological system (44 [19%] of 237 vs 26 [11%] of 230 with SLEDAI-2K).
Domains that were less commonly affected had a wide range of responses. At week 52, more patients who received anifrolumab than placebo obtained a 50% or more reduction in CLASI-A among patients with a CLASI-A of 10 or more at baseline (49 [46%] of 107 vs. 24 [25%] of 94). Patients in the anifrolumab group had a 50% or greater reduction in swollen joint count from baseline to week 52 than those in the placebo group (99 [57%] of 174 vs. 92 [46%] of 200), but the difference between groups was not significant for 50 % or greater reduction in the tender joint count. Anifrolumab therapy improved SLE disease activity across several organ domains in both pivotal phase 3 trials.
Reference:www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(21)00317-9/fulltext
