Sifalimumab may improve symptoms in adult patients with SLE

Sifalimumab, an anti-interferon-alpha monoclonal antibody, may be effective for the treatment of some patients with systemic lupus erythematosus, according to recently published study data.

Researchers studied 431 adult patients with systemic lupus erythematosus (SLE) at 107 sites in 20 countries. Patients with active, severe lupus nephritis or neuropsychological SLE were excluded.

Patients were randomly assigned to 200-mg sifalimumab, 600-mg sifalimumab, 1,200-mg sifalimumab or placebo on days 1, 15 and 29 and every 28 days thereafter for 52 weeks.

Baseline characteristics were similar between randomized groups, except disease duration was shorter in the placebo group and fewer patients in the 600-mg sifalimumab group received concomitant mycophenolate.

At week 52, the number of patients who met the primary efficacy endpoints of at least a 4-point improvement in the SLE Disease Activity Index 2000 (SLEDAI-2K) and no significant worsening of the British Isles Lupus Assessment Group (BILAG) score or physician’s global assessment (PGA) was higher in all treatment groups compared with placebo. The effect peaked at week 24 and then plateaued. A greater number of patients in the treatment groups had improvements in the Cutaneous Lupus Erythematosus Disease Area and Severity Index score, and the percentage of patients who tapered to less than 7.5 mg per day of corticosteroids was higher in the treatment groups.

A greater percentage of patients in all treatment groups had improvements in PGA and a 4-point or greater reduction in the SLEDAI-2K. In the 600-mg and 1,200-mg treatment groups, rates of disease flares requiring glucocorticoids were lower. Among patients with severe joint involvement at baseline, a 50% or greater, dose-related increase in the number of patients who had a decrease in affected joints was found in treatment groups compared with placebo.

No changes in complement or anti-dsDNA levels were found.

One patient who received placebo developed a Herpes zoster infection compared with 19 patients who received treatment, with the highest incidence of infection in the 1,200-mg sifalimumab group. One patient in the 1,200-mg treatment group developed tuberculosis. Several other infections occurred, all of which resolved with treatment. – by Shirley Pulawski

Disclosure s : Khamashta reports the receipt of grant for this study from MedImmune/

AstraZeneca, grants for other work from Bayer and personal consultancy fees from

INOVA Diagnostics, MedImmune, GlaxoSmithKline and UCB. Please see the full study for a list of all other authors’ relevant financial disclosures.

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Source:

Khamashta M, et al. Ann Rheum Dis. 2016;doi:10.1136/annrheumdis-2015-208562.