The following article is a part of conference coverage from the American College of Rheumatology (ACR) Convergence 2021, being held virtually from November 3 to 10, 2021. 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 2021.
In patients with systemic lupus erythematosus (SLE), anifrolumab 300 mg vs placebo was found to have a clinically meaningful benefit with regard to efficacy and safety, regardless of prior biologics use, according to study results presented at the American College of Rheumatology (ACR) Convergence 2021, held virtually from November 3 to 10, 2021.
The current study included data from the TULIP-1 and TULIP-2 phase 3 clinical trials (ClinicalTrials.gov Identifiers: NCT02446912 and NCT02446899, respectively). Both studies included patients with moderate to severe SLE. Prior biologic use with a 3- to 6-month washout period was permitted. Treatment groups included biologic-experienced and biologic-naive, with subgroups receiving 300 mg anifrolumab intravenously every 4 weeks for 48 weeks or placebo.
Efficacy measures included the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at week 52, SLE Responder Index (SRI) of 4 and higher at week 52, sustained oral glucocorticoid taper (£7.5 mg/day prednisone equivalent between weeks 40 to 52 if ³10 mg/day at baseline), and annualized flare rate through week 52. Adverse events were also noted.
Treatment groups included 145 biologic-experienced patients (anifrolumab [n=75] and placebo [n=70]) and 581 biologic-naive patients (anifrolumab [n=285] and placebo [n=296]). The most common previous biologics used were belimumab (n=70), epratuzamab (n=49), tabalumab (n=18), and rituximab (n=14).
Baseline characteristics were generally similar between the biologic-experienced and -naive groups. However, patients with prior biologic use had a longer disease history; they were also more likely to have a Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index score of 1 and higher, anti-dsDNA antibodies, and interferon gene signatures, but less likely to have swollen/tender joints.
Placebo responses were lower in the biologic-experienced group, possibly indicating more refractory disease. Treatment response of anifrolumab vs placebo was higher in the biologic-experienced vs -naive group (BICLA, D=19.4 vs D=16.6; SRI, D=25.3 vs D=9.1; glucocorticoid taper, D=24.7 vs D=17.5, respectively).
Serious adverse events were higher in the biologic-experienced group with both anifrolumab and placebo, except for herpes zoster infections, which were higher with anifrolumab in both the biologic-experienced and -naive groups.
The researchers concluded, “Regardless of whether patients with SLE had previously received biologics, anifrolumab 300 mg provided clinically meaningful benefit over placebo across efficacy endpoints and was generally well tolerated.”
Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of the disclosures.
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Furie R, Morand E, Kalunian K, et al. Efficacy of anifrolumab in patients with SLE previously treated with biologics: post hoc analysis of data from 2 phase 3 trials. Presented at: ACR Convergence 2021; November 3-10, 2021. Abstract 1740