UCL  IRIS
Institutional Research Information Service
UCL Logo
Please report any queries concerning the funding data grouped in the sections named "Externally Awarded" or "Internally Disbursed" (shown on the profile page) to your Research Finance Administrator. Your can find your Research Finance Administrator at https://www.ucl.ac.uk/finance/research/rs-contacts.php by entering your department
Please report any queries concerning the student data shown on the profile page to:

Email: portico-services@ucl.ac.uk

Help Desk: http://www.ucl.ac.uk/ras/portico/helpdesk
Publication Detail
Second-line agents in myositis: 1-year factorial trial of additional immunosuppression in patients who have partially responded to steroids.
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Journal Article
  • Authors:
    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
  • Publication date:
    06/2015
  • Pagination:
    1050, 1055
  • Journal:
    Rheumatology (Oxford)
  • Volume:
    54
  • Issue:
    6
  • Status:
    Published
  • Country:
    England
  • PII:
    keu442
  • Language:
    eng
  • 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, Adrenal Cortex Hormones, Cyclosporine, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Immunosuppressive Agents, Male, Methotrexate, Myositis, Treatment Outcome
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.
Publication data is maintained in RPS. Visit https://rps.ucl.ac.uk
 More search options
UCL Researchers
Author
Comprehensive CTU at UCL
University College London - Gower Street - London - WC1E 6BT Tel:+44 (0)20 7679 2000

© UCL 1999–2011

Search by