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Subcutaneous Administration of Polymerized-type I Collagen for the Treatment of Patients with Rheumatoid Arthritis. An Open-Label Pilot Trial
JANETTE FURUZAWA-CARBALLEDA, ANTONIO R. CABRAL, MARTÍN ZAPATA-ZUÑIGA, and JORGE ALCOCER-VARELA
ABSTRACT. Methods. Eleven patients with active RA on stable therapy with methotrexate (MTX) were enrolled in a 3 month prospective and longitudinal study. Patients were treated weekly with subcutaneous injections of 0.2 ml of collagen-PVP (1.7 mg of collagen) in the 8 most painful joints. The primary endpoints included the Ritchie index (RI), swollen joint count, disease activity score (DAS), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). The secondary endpoints included morning stiffness, pain intensity on a visual analog scale (VAS), and the Spanish-Health Assessment Questionnaire Disability Index (HAQ-DI). Improvement was determined using American College of Rheumatology (ACR) response criteria. Results. Collagen-PVP was safe and well-tolerated and there were no adverse events. Patients had a statistically significant improvement (p < 0.05) in basal versus 3 month's treatment in morning stiffness (D -32.3, -68.6%), RI (D -10.2, -46.4%), swollen joint count (D -10.7, -71.8%), VAS (D -39.9, -63.8%), HAQ-DI (D-0.5, -48.5%), DAS (D -1.35, -70.5%) and ACR20, 50, and 70 (80.0%; 60.0% and 20.0% respectively). We found no differences in serologic or hematologic variables. Conclusion. Collagen-PVP was a safe and well-tolerated drug for the short term treatment of RA. The combination of collagen-PVP plus MTX was more efficacious than MTX alone. However, double-blind placebo-controlled phase II and III clinical trials are necessary to determine whether this drug could be useful in the longterm treatment of RA. (J Rheumatol 2003;30:256-9) Key Indexing Terms:
RHEUMATOID ARTHRITIS
From the Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. J. Furuzawa, PhD; A. Cabral, MD; M. Zapata, MD; J. Alcocer-Varela, MD. Address reprint requests to Dr. J. Alcocer Varela, Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Tlalpan, 14000, Mexico City, Mexico. E-mail: jorgeav@servidor.unam.mx Submitted January 16, 2002; revision accepted June 6, 2002. |