332 EQUIVALENT EFFICACY OF A TOPICAL FORM OF KETOPROFEN (KETUM® 2.5% GEL) AND ORAL DICLOFENAC IN THE TREATMENT OF HAND OSTEOARTHRITIS: RESULTS FROM ARTOPIK STUDY

332 – Table 1. Efficacy results Ketum® 2.5% gel (N=164) Diclofenac per os (N=170) Statistical analysis Change of VAS score* at 7 days (mm) (primary endpoint) -33.2±21.0 -36.9±21.0 [ -1.1 ; 7.4 ] confidence interval of adjusted difference Change of VAS score at 3 days (mm) -19.7±14.4 -21.3±15.5 0.427 (P value of ANCOVA) Change of Dreiser score** at 7 days -6.0±4.4 -6.4±4.4 0.190 (P value of ANCOVA) Change of Dreiser score at 3 days -3.6±3.1 -3.7±3.2 0.568 (P value of ANCOVA) PGA on last assessment Very efficient: 26.4% Very efficient: 33.5% p=0.304 (bilateral Wilcoxon test) Efficient: 36.8% Efficient: 31.8% Moderalety efficient: 27.0% Moderalety efficient: 25.9% Not efficient: 9.8% Not efficient: 8.8% Pain auto-evaluation*** 31.2±8.7 29.5±8.9 p=0.078 (bilateral Wilcoxon test) Therapeutic index**** (physician’s assessment) 2.86±1.00 3.09±0.97 p=0.033 (bilateral Wilcoxon test) *Score from 0mm (no pain) to 100mm (maximal pain). **Score between 0 (no functional disability) and 30 (maximal functional disability). ***Area under the curve of pain auto-evaluation from day 1 until day 7. ****Ratio of efficacy/tolerability, comprised between 0,25 (worst ratio) and 4 (best ratio). Results: 395 patients, predominantly females (74%), with a mean age of 61 years were included. At base-line, mean VAS score and Dreiser score were 70 mm and 12.5, respectively. Both treatment arms were comparable for all the patients’ characteristics. In the FAS population, VAS scores at the end of the treatment [0,4mm to 8,5mm] was slightly outside the equivalence interval. Whereas, in the PP population (n= 334), the result of primary endpoint was [-1,1mm to 7,4mm], demonstrating equivalence of efficacy between Ketum® 2.5% gel and diclofenac per os. Equivalence was also shown for the following secondary efficacy endpoints: VAS scores at 3 days, Dreiser scores at 3 and 7 days, patient efficacy global assessment (PGA) and pain auto-evaluation (see table 1). In terms of tolerability, there was no significant difference between both treatment groups (p=0.108). Conclusions: This present study shows that, in the PP population, Ketum® 2.5% gel and diclofenac per os are equivalent in terms of efficacy for the treatment of hand OA. These results support that Ketum® could be an alternative therapy to oral NSAID treatments.