EXTENDED REPORT

Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial

Matthias Rother¹, Bernard J Lavins², Werner Kneer³, Klaus Lehnhardt⁴, Egbert J Seidel⁵, Stefan Mazgareanu¹

¹ IDEA AG, Muenchen, Germany
² McNeil Consumer and Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc., Fort Washington, USA
³ Orthopaedic Outpatient Centre, Stockach, Germany
⁴ Orthopaedic Outpatient Centre, Bad Duerrheim, Germany
⁵ Zentrum fuer Physikalische und Rehabilitative Medizin, Sophien- und Hufenland-Klinikum, Weimar, Germany

Correspondence to:
Matthias Rother
IDEA AG, Frankfurter Ring 193a, 80807 Muenchen, Germany; rother{at}idea-ag.de

Objective: To compare epicutaneous ketoprofen in Transfersome (ultra-deformable vesicles, IDEA-033) versus oral celecoxib and placebo for relief of signs and symptoms in knee osteoarthritis.

Methods: This was a multicentre, randomised, double-blind, controlled trial; 397 patients with knee osteoarthritis participated and 324 completed the trial. They were randomly assigned 110 mg epicutaneous ketoprofen in 4.8 g Transfersome plus oral placebo (n = 138), 100 mg oral celecoxib plus placebo gel (n = 132), or both placebo formulations (n = 127) twice daily for 6 weeks. Primary efficacy outcome measures were the changes from baseline to end of the study on the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain subscale, physical function subscale and patient global assessment (PGA) of response.

Results: The mean WOMAC pain subscale scores in the intent to treat population were reduced by 18.2 (95% confidence interval –22.1 to –14.3), 20.3 (–24.3 to –16.2) and 9.9 (–13.9 to –5.8) in the IDEA-033, celecoxib and placebo groups, respectively, and the physical function subscale score by 14.6 (–18.1 to –11.0), 16.6 (–20.2 to –13.0) and 10.2 (–13.8 to –6.6), respectively. The mean PGA of response scores were 1.8 (1.6 to 2.1), 1.7 (1.5 to 1.9) and 1.3 (1.1 to 1.5), respectively. The differences in change between IDEA-033 and placebo were statistically significant for pain subscale (p<0.01) and PGA of response (p<0.01). Gastrointestinal adverse events for IDEA-033 were similar to placebo.

Conclusion: IDEA-033 is superior to placebo and comparable with celecoxib in relieving pain associated with an acute flare of knee osteoarthritis.

Abbreviations: COX, cyclooxygenase; GI, gastrointestinal; ITT, intent to treat; NSAIDs, nonsteroidal anti-inflammatory drugs; OMERACT-OARSI, Outcome Measures in Rheumatology initiative/Osteoarthritis Research Society International; PGA, patient global assessment; PP, per protocol; WOMAC, Western Ontario and McMaster Universities; VAS, visual analogue scale

Keywords: Osteoarthritis; ketoprofen; celecoxib; ultra-deformable vesicles

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