Anifrolumab bested placebo across multiple domains in SLE
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Anifrolumab is superior to placebo for improved BILAG-2004 and SLEDAI-2K domain scores, as well as in mucocutaneous and musculoskeletal domains, among patients with systemic lupus erythematosus, according to a speaker at ACR Convergence.
“The TULIP trials were the two phase 3 trials of anifrolumab in active SLE,” Eric F. Morand, MBBS, PhD, FRACP, of Monash University, Melbourne, Australia, told Healio Rheumatology. “Analysis of pooled data is important to allow examination of patterns of response that will inform future practice.”
To further assess the effects of anifrolumab (AstraZeneca) SLE disease activity — specifically organ-specific domains — Morand and colleagues pooled data from the TULIP-1 and TULIP-2 phase 3 trials. According to the researchers, both TULIP studies were 52-week, randomized, double-blind, placebo-controlled trials that analyzed the safety and efficacy of intravenous anifrolumab, administered in 300 mg doses every 4 weeks, among patients with moderately to severely active SLE despite standard-of-care treatment. In all, 360 participants were treated with anifrolumab while 366 received a placebo.
The researchers compared BILAG-2004 and SLEDAI-2K responses in both trials across individual organ domains among patients receiving anifrolumab compared with placebo. Organ improvement was defined as a reduction in baseline BILAG-2004 or SLEDAI-2K organ domain scores and was assessed at week 52. Tender and swollen joint counts were recorded, with improvement defined as a reduction of 50% or more from baseline in both tender and swollen joint counts.
According to the researchers, the percentages of patients with BILAG-2004 A or B and SLEDAI-2K organ domain scores at baseline were generally similar between treatment groups across all organ domains. The most frequently affected organ domains at baseline were mucocutaneous and musculoskeletal, based on both BILAG-2004 and SLEDAI-2K, and immunology based on SLEDAI-2K. Baseline BILAG-2004 A or B scores occurred less frequently in the cardiorespiratory, constitutional, renal, neuropsychiatric, gastrointestinal, hematologic and ophthalmic domains, while baseline SLEDAI-2K activity was less frequent in the hematologic, fever, vascular, renal, cardiorespiratory and central nervous system domains.
After pooling all data, the researchers reported that a greater number of patients treated with anifrolumab demonstrated improvements in the mucocutaneous and musculoskeletal domains, based on both BILAG-2004 and SLEDAI-2K, at week 52 compared with placebo. There were also improvements in most of the less frequently affected domains. In addition, higher percentages of patients treated with anifrolumab, compared with placebo, achieved at least 50% reductions in baseline tender and swollen joint counts at weeks 36, 44, 48 and 52, among those with baseline tender counts of at least 6 and swollen joint counts of at least 8.
“The TULIP trials, like most SLE trials, enrolled patients whose most frequent areas of clinical active disease were mucocutaneous, musculoskeletal,” Morand said. “Anifrolumab was broadly effective across multiple domains, including both of these two most frequently affected domains, as measured by SLEDAI and BILAG scores, as well as specifically against swollen and tender joint counts.”
“If approved, anifrolumab should have broad efficacy across domains in SLE, including the two most common,” he added. “Note, severe CNS and renal disease was not studied in these trials.”
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Morand E. Abstract 1828. Presented at: ACR Convergence 2020; November 5-9, 2020 (virtual meeting).
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