Session Type: ACR Concurrent Abstract Session
Session Time: 4:30PM-6:00PM
Background/Purpose: Odanacatib (ODN) is a selective oral inhibitor of cathepsin K (CatK) in development for the treatment of osteoporosis. Because of reports with the CatK inhibitor balicatib, morphea-like skin lesions were deemed Events of Clinical Interest in the Phase 3 Long-Term Odanacatib Fracture Trial (LOFT; NCT00529373).
Methods: LOFT was a double-blind, placebo-controlled trial. Women ≥65 years with total hip (TH) or femoral neck (FN) bone mineral density (BMD) T-score ≤-2.5, or with a radiographic vertebral fracture and T-score ≤-1.5 at TH or FN, were randomized (1:1) to ODN 50 mg/week or placebo. In a preplanned double-blind extension, 51% of patients continued on their originally assigned treatment up to 5 years. As part of the safety evaluation, external adjudication committees evaluated specific adverse event (AE) categories, including AEs with skin changes suggestive of morphea or systemic sclerosis.
Results: Of 16,713 participants randomized at 388 centers in 40 countries, 16,071 were included in the safety analysis;
Conclusion: Confirmed morphea-like skin lesions were uncommon but occurred more often with ODN than placebo. Although the gross features and histopathology of these lesions were generally consistent with those of spontaneous morphea, in all patients in whom follow-up was obtained improvement or full recovery was reported.
To cite this abstract in AMA style:Saag KG, de Villiers T, Alexandersen P, Jacobe H, Kovarik C, Werth VP, Leung A, Desai-Merchant A, Mattaliano J, Gurner D. Morphea-like Skin Lesions Reported in the Phase 3 Long-Term Odanacatib Fracture Trial and Extension in Postmenopausal Women with Osteoporosis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/morphea-like-skin-lesions-reported-in-the-phase-3-long-term-odanacatib-fracture-trial-and-extension-in-postmenopausal-women-with-osteoporosis/. Accessed May 20, 2019.
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