1)].
Infliximab has been studied only in combination with conventional immunosuppressivetherapy in pediatric Crohn’s disease.
The longer term (greater than 1 year) safety andeffectiveness of infliximab products in pediatric Crohn’s disease patients have not beenestablished in clinical trials.
A pediatric assessment for RENFLEXIS demonstrates that RENFLEXIS is safe and effectivein another pediatric indication. However, RENFLEXIS is not approved for such indicationdue to marketing exclusivity for REMICADE (infliximab).
Juvenile Rheumatoid Arthritis (JRA)
The safety and efficacy of infliximab in patients with juvenile rheumatoid arthritis (JRA)were eva luated in a multicenter, randomized, placebo-controlled, double-blind study for14 weeks, followed by a double-blind, all-active treatment extension, for a maximum of44 weeks. Patients with active JRA between the ages of 4 and 17 years who had been treatedwith MTX for at least 3 months were enrolled. Concurrent use of folic acid, oralcorticosteroids (≤0.2 mg/kg/day of prednisone or equivalent), NSAIDs, and/or diseasemodifying antirheumatic drugs (DMARDs) was permitted.
Doses of 3 mg/kg infliximab or placebo were administered intravenously at Weeks 0, 2 and 6.
Patients randomized to placebo crossed-over to receive 6 mg/kg infliximab at Weeks 14, 16,and 20, and then every 8 weeks through Week 44. Patients who completed the studycontinued to receive open-label treatment with infliximab for up to 2 years in a companionextension study.
The study failed to establish the efficacy of infliximab in the treatment of JRA. Keyobservations in the study included a high placebo response rate and a higher rate ofimmunogenicity than what has been observed in adults. Additionally, a higher rate ofclearance of infliximab was observed than had been observed in adults [see ClinicalPharmacology (12.3)].
A total of 60 patients with JRA were treated with doses of 3 mg/kg and 57 patients weretreated with doses of 6 mg/kg. The proportion of patients with infusion reactions whoreceived 3 mg/kg infliximab was 35% (21/60) over 52 weeks compared with 18% (10/57) inpatients who received 6 mg/kg over 38 weeks. The most common infusion reactions reportedwere vomiting, fever, headache, and hypotension. In the 3 mg/kg infliximab group, 4 patientshad a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 ofwhich were among the serious infusion reactions). In the 6 mg/kg infliximab group, 2 patientshad a serious infusion reaction, 1 of whom had a possible anaphylactic reaction. Two of the6 patients who experienced serious infusion reactions received infliximab by rapid infusion
(duration of less than 2 hours). Antibodies to infliximab developed in 38% (20/53) of patientswho received 3 mg/kg infliximab compared with 12% (6/49) of patients who received6 mg/kg.
A total of 68% (41/60) of patients who received 3 mg/kg infliximab in combination withMTX experienced an infection over 52 weeks compared with 65% (37/57) of patients whoreceived 6 mg/kg infliximab in combination with MTX over 38 weeks. The most commonlyreported infections were upper respiratory tract infection and pharyngitis, and the mostcommonly reported serious infection was pneumonia. Other notable infections includedprimary varicella infection in 1 patient and herpes zoster in 1 patient.
8.5 Geriatric Use
In rheumatoid arthritis and plaque psoriasis clinical trials, no overall differences wereobserv |
