PT  - JOURNAL ARTICLE
AU  - Munther Khamashta
AU  - Joan T Merrill
AU  - Victoria P Werth
AU  - Richard Furie
AU  - Kenneth Kalunian
AU  - Gabor G Illei
AU  - Jorn Drappa
AU  - Liangwei Wang
AU  - Warren Greth
TI  - Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study
AID  - 10.1136/annrheumdis-2015-208562
DP  - 2016 Nov 01
TA  - Annals of the Rheumatic Diseases
PG  - 1909--1916
VI  - 75
IP  - 11
4099  - http://ard.bmj.com/content/75/11/1909.short
4100  - http://ard.bmj.com/content/75/11/1909.full
SO  - Ann Rheum Dis2016 Nov 01; 75
AB  - Objectives The efficacy and safety of sifalimumab were assessed in a phase IIb, randomised, double-blind, placebo-controlled study (NCT01283139) of adults with moderate to severe active systemic lupus erythematosus (SLE).Methods 431 patients were randomised and received monthly intravenous sifalimumab (200 mg, 600 mg or 1200 mg) or placebo in addition to standard-of-care medications. Patients were stratified by disease activity, interferon gene-signature test (high vs low based on the expression of four genes) and geographical region. The primary efficacy end point was the percentage of patients achieving an SLE responder index response at week 52.Results Compared with placebo, a greater percentage of patients who received sifalimumab (all dosages) met the primary end point (placebo: 45.4%; 200 mg: 58.3%; 600 mg: 56.5%; 1200 mg 59.8%). Other improvements were seen in Cutaneous Lupus Erythematosus Disease Area and Severity Index score (200 mg and 1200 mg monthly), Physician's Global Assessment (600 mg and 1200 mg monthly), British Isles Lupus Assessment Group-based Composite Lupus Assessment (1200 mg monthly), 4-point reductions in the SLE Disease Activity Index−2000 score and reductions in counts of swollen joints and tender joints. Serious adverse events occurred in 17.6% of patients on placebo and 18.3% of patients on sifalimumab. Herpes zoster infections were more frequent with sifalimumab treatment.Conclusions Sifalimumab is a promising treatment for adults with SLE. Improvement was consistent across various clinical end points, including global and organ-specific measures of disease activity.Trial registration number NCT01283139; Results.