Background/Purpose

We report on a phase II, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study in subjects with erosive hand osteoarthritis. Subjects must have had a minimum of 6 months’ history of EHOA immediately prior to enrolment to this study.

Methods

Subjects must have had a diagnosis of erosive hand osteoarthritis (EHOA), fulfilling the classification criteria of the American College of Rheumatology (ACR) with a disease duration for at least 6 months. The study included four phases: a pre-randomization phase for up to 35 days, a 91-days double-blind treatment phase, a 77-days open-label treatment phase, and a 28-days observational follow-up phase (to monitor worsening of EHOA). Subjects meeting eligibility criteria at the baseline visit (Visit 2/Day 1) were randomized in parallel 2:1 to either 20 mg PO BID of apremilast or placebo. The primary objective of the study was to evaluate the 84-day efficacy of apremilast 20 mg twice per day [BID], subsequent to a 7-day dose titration, compared with placebo, on the symptoms of erosive hand osteoarthritis.

Results

Until day 85 no patient achieved a 70% improve in AUSCAN and only 2 (7%) achieved a 50% improvement (1 in the apremilast and 1 in the placebo group). 44% of the patients achieved a 20% improve in AUSCAN at day 85 (42% in the apremilast and 50% in the placebo group) and 81% of the patient ended at day 85 with an AUSCAN below the baseline value (89% in the apremilast and 63% in the placebo group). None of the response rates showed a significant difference between apremilast treatment and placebo in the double blind treatment phase. There were small to modest correlations between AUSCAN and HOAMRIS scores (Table 78 and Figure 45) with a correlation coefficient of 0.30 for the linear correlation of the sum of HOAMRIS scores and the total AUSCAN score.

Conclusion

Given the lack of treatment options for patients with EHOA there is unmet need for effective treatment for this disease. Considering the pathophysiology of PDE4 inhibitors we initially considered apremilast as an interesting treatment option for patients with EHOA. However, regarding our pre-limary results we have to conclude that due to the high placebo response rate apremilast failed to meet the primary and secondary objectives in our study. Detailed MRI sub-analyses of responders and non-responders with respect to HOAMRIS scores may allow to define responder profiles in patientes with EHOA.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-phase-2-multicenter-randomized-double-blind-placebo-controlled-parallel-group-efficacy-study-of-apremilast-cc-10004-in-subjects-with-erosive-hand-osteoarthritis/