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Second-line agents in myositis: 1-year factorial trial of additional
immunosuppression in patients who have partially responded to steroids
#MMPMID25433040
Ibrahim F
; Choy E
; Gordon P
; Doré CJ
; Hakim A
; Kitas G
; Isenberg D
; Griffiths B
; Lecky B
; Chakravarty K
; Winer J
; Danko K
; Cooper RG
; White-Alao B
; Scott DL
Rheumatology (Oxford)
2015[Jun]; 54
(6
): 1050-5
PMID25433040
show ga
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.
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