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

Ibrahim, F., Choy, Ernest Ho Sing ORCID: https://orcid.org/0000-0003-4459-8609, Gordon, P., Dore, C. J., Hakim, A., Kitas, G., Isenberg, D., Griffiths, B., Lecky, B., Chakravarty, K., Winer, J., Danko, K., Cooper, R. G., White-Alao, B. and Scott, D. L. 2015. Second-line agents in myositis: 1-year factorial trial of additional immunosuppression in patients who have partially responded to steroids. Rhuematology 54 (6) , pp. 1050-1055. 10.1093/rheumatology/keu442

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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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Subjects:	R Medicine > R Medicine (General)
Uncontrolled Keywords:	myositis and muscle disease, rheumatic diseases, DMARDs therapies, immunosuppressant thera- pies, clinical trials and methods, basic and clinical sciences, quality of life, psychology and social phenomena
Publisher:	Oxford University Press
ISSN:	1462-0324
Date of First Compliant Deposit:	17 September 2019
Date of Acceptance:	22 September 2014
Last Modified:	05 May 2023 19:11
URI:	https://orca.cardiff.ac.uk/id/eprint/84753

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