The following article is a part of conference coverage from the American College of Rheumatology Convergence 2020, being held virtually from November 5 to 9, 2020. The team at Rheumatology Advisor will be reporting on the latest news and research conducted by leading experts in rheumatology. Check back for more from the ACR Convergence 2020.
Rapid and sustained improvements in skin-specific systemic lupus erythematosus (SLE) were seen in patients with mild to severe baseline cutaneous activity who received anifrolumab, according to study results presented at the American College of Rheumatology (ACR) Convergence 2020, held virtually from November 5 to 9, 2020.
In the phase 3 TULIP-1 and TULIP-2 trials, a greater percentage of patients with SLE and a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) score of 10 or greater at baseline who received anifrolumab vs placebo achieved a 50% or greater disease severity reduction at week 12.
In the current study, the researchers sought to further evaluate the effects of anifrolumab on skin-specific SLE disease activity using pooled data from the TULIP-1 and TULIP-2 trials.
Data were pooled from both the 52-week, randomized, double-blind trials, and skin responses were compared between patients receiving anifrolumab and those receiving placebo. A CLASI-A response was defined as a 50% or greater reduction in CLASI-A score from baseline in patients with a baseline CLASI-A score of 10 or greater. A Cox proportional hazards model was used to evaluate time to CLASI-A response sustained to week 52.
In total, 360 patients with moderate to severe active SLE received 300 mg of intravenous anifrolumab every 4 weeks for 48 weeks, along with their standard-of-care treatment. A total of 366 patients received placebo. At baseline, 95.9% of the combined patient groups (n=696) had a CLASI-A score of greater than 0, and 27.7% (n=201) had a CLASI-A score of 10 or greater (balanced between groups). In the subgroup of patients with baseline CLASI-A score of 10 or greater, reduction of 50% of greater by week 12 was seen in 46.0% of patients (n=49) receiving anifrolumab vs 24.9% of those (n=24) receiving placebo (difference, 21.0; 95% CI, 8.1%-34.0%; nominal P <.001). Researchers recorded separation between treatment groups as early as week 8 (difference, 14.3; 95% CI, 1.8%-26.9%; nominal P <.02).
Patients who received anifrolumab showed sustained time to CLASI-A response to week 52 in the TULIP-1 (hazard ratio [HR], 1.91; 95% CI, 1.14-3.27) and TULIP-2 trial (HR, 1.55; 95% CI, 0.87-2.85). In the subgroup of patients with baseline CLASI-A scores greater than 0, more patients achieved a CLASI-A response of 50% or greater reduction by week 12 in the anifrolumab vs placebo groups in both the TULIP-1 and TULIP-2 trial (nominal P <.05). The subgroup of patients with baseline CLASI-A scores of 10 or greater in both the TULIP-1 and TULIP-2 trial demonstrated similar results (nominal P <.05).
Researchers concluded that their findings “support the potential of anifrolumab to reduce skin disease activity in patients with moderately to severely active SLE.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures. The study was sponsored by AstraZeneca.
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Werth V, Furie R, Morand E, et al. Early and sustained reduction in severity of skin disease with anifrolumab treatment in patients with active SLE measured by the cutaneous lupus erythematous disease area and severity index (CLASI): pooled data from 2 phase 3 studies. Presented at: ACR Convergence 2020; November 5-9, 2020. Abstract 0985.