A randomized,double-blind,placebo-controlled trial of infliximab in refractory polymyositis and dermatomyositis |
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| Affiliation: | 1. Environmental Autoimmunity Group, National Institute of Environmental Health Sciences;2. National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health;3. Clinical Center, NIH, Department of Rehabilitation Medicine;1. Environmental Autoimmunity Group, Clinical Research Branch, National Institute of Environmental Health Sciences, National Institutes of Health, Building 10, Rm 4-2352, MSC 1301, 10 Center Drive, Bethesda, MD 20892-1301;2. National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD;3. Division of Rheumatology, IWK Health Centre and Dalhousie University, Halifax, Nova Scotia, Canada;4. Division of Rheumatology, Department of Medicine, George Washington University School of Medicine, Washington, DC;5. VA Medical Center, University of Oklahoma Health Sciences Center, and Oklahoma Medical Research Foundation, Oklahoma City, OK;6. Social & Scientific Systems, Inc., Durham, NC;1. Servicio de Reumatología, Hospital Universitario Virgen Macarena, Sevilla, España;2. Unidad de imagen, Servicio Reumatología, Hospital Universitario Virgen Macarena, Sevilla, España;1. Environmental Autoimmunity Group, National Institute of Environmental Health Sciences, National Institutes of Health, Bethesda, MD;2. Department of Transfusion Medicine, NIH Clinical Center, National Institutes of Health, Bethesda, MD;3. Veterans Affairs Medical Center, University of Oklahoma Health Sciences Center, Oklahoma Medical Research Foundation, Oklahoma City, OK;4. Myositis Center, University of Pittsburgh School of Medicine, Pittsburgh, PA;5. Division of Rheumatology, Mayo Clinic, Rochester, MN;6. Johns Hopkins Myositis Center, Johns Hopkins University School of Medicine, Baltimore, MD;7. Departments of Neurology and Medicine, Johns Hopkins University School of Medicine, Baltimore, MD;8. Department of Neurology, Mid-Atlantic Permanente Research Institute, Kaiser Permanente, Rockville, MD;9. Division of Rheumatology, Immunology, and Allergy, Brigham and Women''s Hospital, Boston, MA;10. Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD;11. National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD;1. Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania;2. Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania;4. Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania;3. University of Texas Southwestern Medical Center, Dallas, Texas;1. Department of Dermatology, Stanford University School of Medicine, Redwood City, California;2. Department of Rheumatology, University of Michigan, Ann Arbor, Michigan;3. Department of Clinical Immunology, Medical Faculty, University of Debrecen, Debrecen, Hungary;4. Department of Neurology, University of California Irvine, Irvine, California;5. Idera Pharmaceuticals, Inc, Exton, Pennsylvania;1. Department of Rheumatology, centre hospitalier Lyon Sud, 165, chemin du Grand-Revoyet, 69495 Pierre-Bénite, France;2. University of Lyon I, 69007 Lyon, France |
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| Abstract: | ObjectiveTo investigate in a pilot study the safety and efficacy of infliximab in patients with refractory dermatomyositis (DM) and polymyositis (PM).MethodsA randomized, double-blind, placebo-controlled trial including subjects with active DM or PM. Participants had stable doses of immunosuppressive medication and prednisone (≤0.5 mg/kg/day), and exhibited clinical signs of muscle weakness for at least 4 weeks prior to study entry. Participants received infusions of either placebo or infliximab 5 mg/kg at 0, 2, 6, and 14 weeks in blinded manner. The primary outcome was a ≥15% manual muscle strength (MMT) improvement at week 16 compared to week 0. The secondary outcome measures were improvement defined by the International Myositis Assessment and Clinical Studies Group (IMACS) criteria. At week 16, responders in each arm had the option of either continuing the same treatment or changing to the non-responder treatment for that study arm. Non-responders in the 5 mg/kg infliximab arm were increased to infliximab 7.5 mg/kg for weeks 22, 30, and 38. Non-responders in the placebo arm at week 16 received infliximab 5 mg/kg at weeks 16, 18, 22, 30, and 38. Outcomes were reassessed at week 40.ResultsTwelve subjects completed the study to week 16. Six of the 12 subjects received infliximab treatment at the dose of 5 mg/kg with only one subject meeting the responder criteria at that dose. Of the remaining five subjects on infliximab, three crossed over to the infliximab 7.5 mg/kg dose. One of those three subjects responded. All six patients in the placebo arm crossed over to the 5 mg/kg dosing regimen after week 16, and two of those responded to infliximab.ConclusionsInfliximab therapy for patients with refractory PM and DM was well tolerated and may benefit a subset of patients. |
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| Keywords: | Polymyositis Dermatomyositis Infliximab TNF inhibitor |
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