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FRI0300 A large randomised, controlled trial comparing the efficacy and safety of topical ketoprofen in transfersome gel with oral celecoxib for osteoarthritis knee pain
  1. P.G. Conaghan1,
  2. J.D. Dickson2,
  3. W. Bolten3,
  4. G. Cevc4,
  5. M. Rother5
  1. 1University of Leeds, Leeds
  2. 2Redcar and Cleveland PCT, Darlington, United Kingdom
  3. 3Rheumaklinik Wiesbaden, Klaus-Miehlke-Klinik, Wiesbaden
  4. 4Advanced Treatments Institute, Gauting
  5. 5IMR Partner GmbH, Munich, Germany

Abstract

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 1). 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 1. Efficacy and safety outcomes

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, Servier, J. Dickson: None Declared, W. Bolten: None Declared, G. Cevc Employee of: Past employee of IDEA AG, M. Rother Shareholder of: IDEA AG (sponsor of the trial), Employee of: IDEA AG (sponsor of the trial) at the time of trial conduct

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