Efficacy of repeated intravenous infusions of an anti–tumor necrosis factor α monoclonal antibody, infliximab, in persistently active, refractory juvenile idiopathic arthritis: Results of an open‐label prospective study

• Published in: Arthritis and rheumatism 2005-02, Vol.52 (2), p.548-553
• Main Authors: Gerloni, Valeria, Pontikaki, Irene, Gattinara, Maurizio, Desiati, Francesca, Lupi, Elide, Lurati, Alfredomaria, Salmaso, Alessandra, Fantini, Flavio
• Format: Article
• Language: English
• Subjects: Adolescent; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antirheumatic Agents - administration & dosage; Antirheumatic Agents - adverse effects; Arthritis, Juvenile - drug therapy; Biological and medical sciences; Blood Sedimentation; C-Reactive Protein - analysis; Child; Child, Preschool; Diseases of the osteoarticular system; Drug Therapy, Combination; Female; Humans; Immunomodulators; Infant; Inflammatory joint diseases; Infliximab; Infusions, Intravenous; Medical sciences; Methotrexate - administration & dosage; Pharmacology. Drug treatments; Pilot Projects; Prospective Studies; Treatment Outcome
• ISSN: 0004-3591; 1529-0131
• DOI: 10.1002/art.20793

Objective To evaluate the efficacy and safety of a chimeric monoclonal anti–tumor necrosis factor α antibody (infliximab) with methotrexate (MTX) in juvenile idiopathic arthritis (JIA) with an active polyarticular course that is not responsive to MTX. Methods Twenty‐four young adults with long‐lasting, refractory JIA were enrolled in an open, prospective, 2‐year pilot study. Patients received intravenous infliximab at 3 mg/kg of body weight at weeks 0, 2, and 6 and every 8 weeks thereafter, with weekly subcutaneous MTX. Results The median duration of therapy was 9.1 months. Significant improvements were observed in the number of joints (28‐joint count) with active disease (median 6 at baseline, 2 at 2 weeks, 0 at 6 months, 0 at 1 year; P < 0.05). Pain as well as patient's and physician's global assessments of disease status were assessed on 0–100‐mm (0 = best; 100 = worst) visual analog scales (VAS). There were significant improvements in VAS pain scores (45 at baseline, 25 at 2 weeks, 8.5 at 6 months, 10 at 1 year; P < 0.05), patient's global assessment of disease status (50 at baseline, 22 at 2 weeks, 11.5 at 6 months, 18 at 1 year; P < 0.05), and physician's global assessment of disease status (50.5 at baseline, 22.5 at 2 weeks, 6.5 at 6 months, 10 at 1 year; P < 0.01). In addition, there were significant improvements in the erythrocyte sedimentation rate (64 mm/hour at baseline, 36 mm/hour at 2 weeks, 23.5 mm/hour at 6 months, 35 mm/hour at 1 year; P < 0.01) and C‐reactive protein level (4.9 mg/dl at baseline, 2.8 mg/dl at 2 weeks, 3.1 mg/dl at 6 months, 3.2 mg/dl at 1 year; P < 0.005). The percentage of patients meeting the American College of Rheumatology 20% improvement criteria at each assessment ranged from 54.2% to 86.7%. Of the responses on the Disease Activity Score in 28 joints, 37.5–63.6% were classified as “good,” 14.3–33.3% were classified as “moderate,” and 18–37.5% were classified as “no response.” Twelve patients (50%) had adverse events, and 5 patients (20.8%) withdrew. Conclusion Infliximab plus MTX showed high effectiveness and safety in short‐ and medium‐term treatment of long‐lasting refractory JIA. A controlled multicenter clinical trial is needed.