Anifrolumab Superior to Placebo in Moderate to Severe Systemic Lupus Erythematosus

lupus of the cheek
lupus of the cheek
Although the first phase 3 trial of anifrolumab did not meet its primary end point, other study end points that were met suggested a clinical benefit for the monoclonal antibody in systemic lupus erythematosus.

The following article is a part of conference coverage from the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, being held in Atlanta, Georgia. 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 2019 ACR/ARP Annual Meeting.

ATLANTA ­– Compared with placebo, anifrolumab was found to demonstrate robust efficacy in patients with moderate to severe systemic lupus erythematosus (SLE), according to research presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019, in Atlanta, Georgia.

An international team of researchers conducted TULIP-2 ( Identifier: NCT02446899), a phase 3 randomized, double-blind, placebo-controlled trial, to evaluate the safety and efficacy of anifrolumab compared with placebo in patients with SLE.

Patients were eligible for the study if they met ACR SLE criteria and had an SLE Disease Activity Index (SLEDAI)-2K score ≥6 and a British Isles Lupus Assessment Group (BILAG) index A score ≥1 or B score ≥2. The primary end point was achievement of BILAG-Based Composite Lupus Assessment (BICLA) response at week 52. Standard of care was stable, with the exception of tapering of oral corticosteroids to a prednisone equivalent ≤7.5 mg/d in patients receiving ≥10 mg/d at baseline.

A total of 362 patients received either ≥1 dose of anifrolumab 300 mg intravenously (n=180) or placebo (n=182) every 4 weeks for 48 weeks. Baseline demographics and disease characteristics were similar between the 2 groups; 85.5% of patients in the anifrolumab group completed treatment compared with 71.4% of those in the placebo group.

Anifrolumab was found to be superior to placebo both in BICLA response (47.8% vs 31.5%, respectively; P=.001) and in meeting key secondary end points, including oral corticosteroid reduction and the Cutaneous Lupus Erythematosus Disease Area and Severity Index response. Annualized flare rates were lower in patients who received anifrolumab compared with those who received placebo (0.64 vs 0.43, respectively; rate ratio, 0.67; 95% CI, 0.48-0.94; P=.081).

Anifrolumab also demonstrated efficacy in multiple secondary end points, including SLE responder index (SRI)4, higher thresholds of SRI(5-8), time to onset of BICLA response sustained to week 52, and time to first flare.

There was no significant difference in the safety profile of anifrolumab as compared with that of previous trials. Herpes zoster was more common in patients who received anifrolumab compared with those who received placebo (7.2% vs 1.1%, respectively). However, serious adverse events and those leading to treatment discontinuation occurred less frequently in the anifrolumab vs placebo group (8.3% vs 17.0% and 2.8% vs 7.1%, respectively). Few patients (0.6%) developed antidrug antibodies, and 1 death occurred as a result of pneumonia in a patient receiving anifrolumab.

Overall, the TULIP-2 study demonstrated that among patients with SLE, anifrolumab was superior to placebo for multiple end points including disease activity, skin disease, and oral corticosteroid tapering, with no new safety signals identified.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Morand E, Furie R, Tanaka Y, et al. Efficacy and safety of anifrolumab in patients with moderate to severe systemic lupus erythematosus: results of the second phase 3 randomized controlled trial. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract L17.