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2016 ; 75
(11
): 1909-1916
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gab.com Text
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English Wikipedia
Sifalimumab, an anti-interferon-? monoclonal antibody, in moderate to severe
systemic lupus erythematosus: a randomised, double-blind, placebo-controlled
study
#MMPMID27009916
Khamashta M
; Merrill JT
; Werth VP
; Furie R
; Kalunian K
; Illei GG
; Drappa J
; Wang L
; Greth W
Ann Rheum Dis
2016[Nov]; 75
(11
): 1909-1916
PMID27009916
show ga
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.