medwireNews: A post-hoc analysis of data from the TULIP-1 and TULIP-2 trials suggests that anifrolumab treatment improves disease activity across different organ systems among people with moderate-to-severe systemic lupus erythematosus (SLE).
The type I interferon receptor antagonist was approved by the US FDA and recommended for approval by the EMA in 2021 on the basis of the TULIP-1 and -2 trials. Raj Tummala (AstraZeneca, Gaithersburg, Maryland, USA) and co-investigators say that “[g]iven the clinical heterogeneity of SLE, a particularly important attribute of a new therapy is its ability to reduce disease activity regardless of the pattern of organ system involvement.”
To evaluate this, Tummala et al analyzed data from 726 trial participants, among whom the most frequently affected organ systems at baseline were musculoskeletal (89% according to BILAG-2004 criteria and 94% according to SLEDAI-2K) and mucocutaneous (86% and 96%, respectively).
At the 1-year follow-up, the 360 participants treated with anifrolumab 300 mg every 4 weeks were more likely to achieve a BILAG-2004 musculoskeletal response than the 366 individuals given placebo, at rates of 56% versus 44%. Similarly, musculoskeletal response rates by the SLEDAI-2K criteria were higher in the anifrolumab than the placebo arm, at 49% versus 40%.
The authors note that the p values for the respective between-group differences of 12 (p=0.0025) and 9 (p=0.025) percentage points are nominal because “this is a post-hoc analysis […] and no adjustment for multiple testing has been applied.”
Anifrolumab-treated patients were also more likely than those given placebo to have a mucocutaneous response defined by the BILAG-2004 (54 vs 38%) or SLEDAI-2K (55 vs 39%) criteria, and an immunologic response by SLEDAI-2K (19 vs 11%). These between-group differences all met the criteria for nominal significance.
Tummala and team say that “[l]ess frequently affected domains had varied responses.” For instance, a greater proportion of people given anifrolumab versus placebo experienced improvements in the cardiorespiratory, hematologic, renal, and vascular SLEDAI-2K domains, but the between-group differences only reached nominal significance for the hematologic domain (56 vs 31%; p=0.028).
“Together, these results provide evidence of the benefit of anifrolumab for reduction of disease activity across multiple organ domains among patients with active SLE,” write the researchers in The Lancet Rheumatology.
They caution, however, that “[t]he TULIP-1 and TULIP-2 trials were not powered or designed to demonstrate efficacy in individual organ domains,” and call for future research “to examine anifrolumab efficacy in less commonly affected organ domains, especially as patients with severe active lupus nephritis and severe neuropsychiatric manifestations were excluded from these studies.”
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