Does the addition of ketotifen to non-steroidal anti-inflammatory drugs confer any additional benefit in rheumatoid arthritis?

Ketotifen (benzocycloheptathiophene) was evaluated in a double-blind study of patients with active rheumatoid arthritis. Sixty patients were randomly allocated to receive active or matching placebo drug and reviewed 6 weekly for 24 weeks. Conventional NSAIDs were continued throughout. Disease activity was assessed clinically and biochemically at weeks 0, 12 and 24. Nineteen patients remained on active drug for 24 weeks and 11 on placebo. Significant improvement in articular index was seen in both groups but no objective improvement was noted in either group. No undue toxicity was encountered in either group. Use of a drug considered to have selective LTC4 and LTD4 antagonism in combination with conventional cyclo-oxygenase inhibitors did not confer any additional benefit in rheumatoid arthritis.

RCT Entities:   Population Interventions Outcomes