A randomized, double-blind, placebo-controlled trial of infliximab in refractory polymyositis and dermatomyositis.

ABSTRACT:

Objective

To investigate in a pilot study the safety and efficacy of infliximab in patients with refractory dermatomyositis (DM) and polymyositis (PM).

Methods

A randomized, double-blind, placebo-controlled trial including subjects with active DM or PM. Participants had stable doses of immunosuppressive medication and prednisone (≤0.5mg/kg/day), and exhibited clinical signs of muscle weakness for at least 4 weeks prior to study entry. Participants received infusions of either placebo or infliximab 5mg/kg at 0, 2, 6, and 14 weeks in blinded manner. The primary outcome was a ≥15% manual muscle strength (MMT) improvement at week 16 compared to week 0. The secondary outcome measures were improvement defined by the International Myositis Assessment and Clinical Studies Group (IMA

SUBMITTER: Schiffenbauer A 

PROVIDER: S-EPMC6208161 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature