Open-Label Trial of Anti-TNF-α in Dermato- and Polymyositis Treated Concomitantly with Methotrexate

Abstract

Background/Aims: To determine the efficacy of infliximab combined with weekly methotrexate in drug-naive recent-onset dermatomyositis and polymyositis. Methods: A multicentre open-label controlled trial was conducted. Disease activity was assessed using patient’s and physician’s disease activity assessment, manual muscle testing (MMT), handheld dynamometry, and serum CK. The primary objective was to assess the efficacy using MMT after a period of 26 weeks. Results: The study was terminated prematurely because of a low inclusion rate and a high drop-out rate due to disease progression and the occurrence of an infusion reaction. The few patients who did reach the primary endpoint showed improvement in all aspects studied. Conclusion: Infliximab combined with weekly methotrexate might be safe and well tolerated in a small subgroup of patients with drug-naive recent-onset myositis. At present, we do not advocate the use of this treatment because treatment response cannot be predicted beforehand.

Current pharmacological treatment of idiopathic inflammatory myopathies

“…The lack of improvement in muscle strength was associated with persistent signs of inflammation in muscle biopsies or on MRI of thigh muscles. Similar results were reported in an open-label trial of infliximab combined with weekly methotrexate in drug-naive patients [76], which was terminated prematurely because of a difficulty in recruiting cases, due to disease progression and the occurrence of adverse events. Thus, at present, the use of infliximab in patients with treatmentresistant myositis is not recommended.…”

High Frequencies and co-existing of myositis-specific autoantibodies in patients with idiopathic inflammatory myopathies overlapped to rheumatoid arthritis

“…TNF expression is detected within inXamed muscle in situ, and anti-TNF agents are sometimes used to treat intractable myositis [14,15]. Several investigators, including Hall et al, have reported cases of RA treated by anti-TNF agents in which myositis developed at a later point [16][17][18].…”

Immunotherapies for Immune-Mediated Myopathies: A Current Perspective

“…While early case series reported positive effects [80][81][82][83][84][85][86], there has been increasing concern over these drugs due to some recent reports of disease flares or the initiation of myositis with TNF-α therapies [87][88][89][90]. An open-label study looking at the efficacy of infliximab combined with methotrexate was terminated owing to a low inclusion rate and a high dropout rate due to disease progression or side effects [91]. Another open-label study of infliximab performed in 13 patients with refractory DM/PM/IBM found no patients improved in muscle strength, measured by manual muscle testing, and several patients actually worsened [92].…”