Anifrolumab demonstrated efficacy in improving disease activity across multiple organ domains in patients with systemic lupus erythematosus (SLE), according to study results published in Lancet Rheumatology.
Researchers aimed to study the efficacy of anifrolumab on organ domain-specific SLE disease activity.
In the current post-hoc analysis of the placebo-controlled, randomized phase 3 TULIP-1 and TULIP-2 trials (ClinicalTrials.gov Identifiers: NCT02446912 and NCT02446899, respectively), patients with moderate to severe SLE were included. Of 726 participants, 360 received treatment with intravenous anifrolumab 300 mg (once every 4 weeks for 48 weeks) and 366 received treatment with placebo. Changes were evaluated from week 0 to 52 using the SLE Disease Activity Index 2000 (SLEDAI-2K) and the British Isles Lupus Assessment Group 2004 (BILAG-2004) organ domain scores; hematology; swollen and tender joint counts; serology; and the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score (CLASI-A).
Mean age of participants was 41.8±11.9 years; 93% were women; and 66% were White. At baseline, the most affected organ domains were mucocutaneous (86% using BILAG-2004 and 96% using SLEDAI-2K); immunologic (64% using SLEDAI-2K), and musculoskeletal (89% using BILAG-2004 and 94% [using SLEDAI-2K).
The anifrolumab group had higher musculoskeletal improvements compared with placebo at week 52 with BILAG-2004 (56% vs 44%, respectively; difference, 11.8% [95% CI, 4.2%-19.4%]; P =.0025), and SLEDAI-2K (49% vs 40%, respectively; difference, 8.5% [95% CI, 1.1%-15.8%]; P =.025). Similar improvements were observed in the mucocutaneous system with BILAG-2004 (54% vs 38%, respectively; difference, 15.5% [95% CI, 7.8%-23.2%]; P <.0001) and SLEDAI-2K (55% vs 39%; difference, 15.4% [95% CI, 8.1%-22.6%]; P <.0001), as well as in the immunologic system using SLEDAI-2K (19% vs 11%; difference, 7.4% [95% CI, 0.5%-14.3%]; P =.037).
Varied responses were observed among less frequently affected domains. Among those with a baseline CLASI-A score 10 or more (n=201), the anifrolumab group had higher CLASI-A responses at week 12 compared with placebo (46% vs 25%; difference, 21.0% [95% CI, 8.1%-34.0%]; P =.0015). While intergroup differences were not significant for 50% or greater reduction in tender joint count at week 52, the percentage of patients with 50% or more reduction in swollen joint count was higher with anifrolumab compared with placebo for those with 6 or more swollen joints at baseline (57% vs 46%; difference, 11.4% [95% CI, 1.3%-21.5%]; P =.027).
Limitations to this study included the inability to assess efficacy in individual organ domains, compare data interpretations between studies, and a lack of sex-related outcome measurements.
The study researchers concluded that “These conclusions must be balanced against the safety of anifrolumab; we have separately reported pooled safety data in which respiratory infections and herpes zoster were reported more frequently in anifrolumab-treated patients than in those who received placebo.”
Disclosure: This clinical trial was supported by AstraZeneca. Please see the original reference for a full list of authors’ disclosures.
Morand EF, Furie RA, Bruce IN, et al. Efficacy of anifrolumab across organ domains in patients with moderate-to-severe systemic lupus erythematosus: a post-hoc analysis of pooled data from the TULIP-1 and TULIP-2 trials. Published online February 3, 2022. Lancet Rheum. doi:10.1016/S2665-9913(21)00317-9