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

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.

• Authors: Fowzia Ibrahim, Ernest Choy, Patrick Gordon, Caroline J Doré, Alan Hakim, George Kitas, David Isenberg, Bridget Griffiths, Bryan Lecky, Kuntal Chakravarty, John Winer, Katalin Danko, Robert G Cooper, Beverley White-Alao, David L Scott
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 54 Issue 6 Pg. 1050-5 (Jun 2015) ISSN: 1462-0332 [Electronic] England
• PMID: 25433040 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Chemical References

• Adrenal Cortex Hormones
• Immunosuppressive Agents
• Cyclosporine
• Methotrexate

Topics

• Adrenal Cortex Hormones (therapeutic use)
• Cyclosporine (therapeutic use)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Immunosuppressive Agents (therapeutic use)
• Male
• Methotrexate (therapeutic use)
• Myositis (drug therapy)
• Treatment Outcome