FRI0300
A LARGE RANDOMISED, CONTROLLED TRIAL COMPARING THE EFFICACY AND SAFETY OF TOPICAL KETOPROFEN IN TRANSFERSOME GEL WITH ORAL CELECOXIB FOR OSTEOARTHRITIS KNEE PAIN
P. G. Conaghan 1,*J. D. Dickson 2W. Bolten 3G. Cevc 4M. Rother 5
1University Of Leeds, Leeds, 2Redcar and Cleveland PCT, Darlington, United Kingdom, 3Rheumaklinik Wiesbaden, Klaus-Miehlke-Klinik, Wiesbaden, 4Advanced Treatments Institute, Gauting, 5IMR Partner GmbH, Munich, Germany
Background: IDEA 033 is a topically applied osteoarthritis (OA) treatment that uses novel Transfersome (TM IDEA AG) – an aqueous dispersion of ultra-deformable carriers – to deliver ketoprofen to soft tissue.
Objectives: To evaluate the efficacy and safety of 2 doses of IDEA 033 in people with OA knee pain and to compare the efficacy with celecoxib.
Methods: A multicentre, randomised, double-blind, placebo- and active-controlled study in pts with ACR criteria OA knee with moderate pain at baseline (rating of ≥4 for question 1 WOMAC 3.1 and total average WOMAC pain subscale <7). Pts received 12 wks twice daily of 50mg or 100mg ketoprofen in Transfersome or matched placebo (gel without ketoprofen; TDT 064); 100mg celecoxib or oral placebo. WOMAC pain and function were assessed at baseline and wks 2, 6, 9 and 12. Pts’ global assessment of response was measured on a Likert scale at wk 12. Primary outcome was change in WOMAC pain subscale score at wk 12 for 100mg ketoprofen in Transfersome vs matching placebo.
Results: The intent-to-treat and safety populations comprised 1395 patients. Throughout the treatment period, all study arms displayed a decrease in pain (Table). Treatment with 100mg ketoprofen in Transfersome was non-inferior to celecoxib (Mann–Whitney Estimator=0.4468; predefined benchmark of test for non-inferiority=0.4), and was not superior to topical placebo. Both doses of ketoprofen in Transfersome and matching placebo groups were superior to oral placebo at a magnitude comparable to celecoxib. All groups reported a considerable improvement in physical function. No treatment-related serious AEs were reported. Table. Efficacy and safety outcomes
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Conclusions: Treatment for 12 wks with topically applied ketoprofen (50mg and 100mg) in Transfersome was not statistically superior to treatment with matching NSAID-free Transfersome gel. However, there was significant superiority for all Transfersome applications and celecoxib vs oral placebo. All treatments were well tolerated. Investigation of the beneficial effects of the NSAID-free Transfersome gel (TDT 064) is ongoing.
Disclosure of Interest: P. Conaghan Consultant for: Servier Speakers Bureau: AstraZeneca, ServierJ. Dickson: None DeclaredW. Bolten: None DeclaredG. Cevc Employee of: Past employee of IDEA AGM. Rother Shareholder of: IDEA AG (sponsor of the trial) Employee of: IDEA AG (sponsor of the trial) at the time of trial conduct