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Randomized Controlled Trial
. 2015 Jun;54(6):1050-5.
doi: 10.1093/rheumatology/keu442. Epub 2014 Nov 27.

Second-line agents in myositis: 1-year factorial trial of additional immunosuppression in patients who have partially responded to steroids

Fowzia Ibrahim  1 , Ernest Choy  2 , Patrick Gordon  2 , Caroline J Doré  2 , Alan Hakim  2 , George Kitas  2 , David Isenberg  2 , Bridget Griffiths  2 , Bryan Lecky  2 , Kuntal Chakravarty  2 , John Winer  2 , Katalin Danko  2 , Robert G Cooper  2 , Beverley White-Alao  2 , David L Scott  2
Affiliations
Randomized Controlled Trial

Second-line agents in myositis: 1-year factorial trial of additional immunosuppression in patients who have partially responded to steroids

Fowzia Ibrahim et al. Rheumatology (Oxford). 2015 Jun.

Abstract

Objective: Ciclosporin and MTX are used in idiopathic inflammatory myopathies (DM and PM) when patients incompletely respond to glucocorticoids. Their effectiveness is unproved in randomized controlled trials (RCTs). We evaluated their benefits in a placebo-controlled factorial RCT.

Methods: A 56-week multicentre factorial-design double-blind placebo-controlled RCT compared steroids alone, MTX (15-25 mg weekly) plus steroids, ciclosporin (1-5 mg/kg/day) plus steroids and all three treatments. It enrolled adults with myositis (by Bohan and Peter criteria) with active disease receiving corticosteroids.

Results: A total of 359 patients were screened and 58 randomized. Of the latter, 37 patients completed 12 months of treatment, 7 were lost to follow-up and 14 discontinued treatment. Patients completing 12 months of treatment showed significant improvement (P < 0.001 on paired t-tests) in manual muscle testing (14% change), walking time (22% change) and function (9% change). Intention to treat and completer analyses indicated that ciclosporin monotherapy, MTX monotherapy and ciclosporin/MTX combination therapy showed no significant treatment effects in comparison with placebo.

Conclusion: Neither MTX nor ciclosporin (by themselves or in combination) improved clinical features in myositis patients who had incompletely responded to glucocorticoids.

Trial registration: International Standard Randomized Controlled Trial Number Register; http://www.controlled-trials.com/; ISRCTN40085050.

Keywords: DMARDs therapies; basic and clinical sciences; clinical trials and methods; immunosuppressant therapies; myositis and muscle disease; psychology and social phenomena; quality of life; rheumatic diseases.

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Figures

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Fig. 1
CONSORT flowchart for the SELAM trial
See this image and copyright information in PMC

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