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The following article is a part of conference coverage from the American College of Rheumatology (ACR) Convergence 2021, being held virtually from November 3 to 10, 2021. The team at Rheumatology Advisor will be reporting on the latest news and research conducted by leading experts in rheumatology. Check back for more from the ACR Convergence 2021. |
Patients with knee osteoarthritis (OA) who received treatment with lorecivivint and had baseline medial joint space width (mJSW) of 2 to 4 mm without widespread pain had improved patient-reported outcomes (PROs), according to study results presented at the American College of Rheumatology (ACR) Convergence 2021, held virtually from November 3 to 10, 2021.
Researchers conducted a post-hoc analysis of a 24-week phase 2b trial on the effects of lorecivivint on PROs in patients without widespread pain and with baseline mJSW of 2 to 4 mm.
Eligible participants had knee OA with KL grades 2 to 3 and Pain Numeric Rating Scale (NRS) values of at least 4 and within 8 in the target knee and less than 4 in the contralateral knee. At baseline, patients either received a 2 mL injection of 0.03 mg, 0.07 mg, 0.15 mg, or 0.23 mg lorecivivant or placebo. Point estimates and effect sizes of the Full Analysis Set (FAS; all dosed participants) compared with a post-hoc analysis of patients with a baseline mJSW of 2 to 4 mm without widespread pain were analyzed. Results from participants receiving the planned phase 3 dose of 0.07 mg lorecivivint in the target knee were also reported.
The PRO endpoints included change in daily OA target knee pain by NRS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, WOMAC Physical Function, and Patient Global Assessment.
Overall, 635 participants (mean age, 59.0±8.5 years; 58.4% women) completed the study. At week 12, the FAS and participants with mJSW of 2 to 4 mm without widespread pain experienced significant improvements with lorecivivant compared with placebo (P <.05) for several measures of pain. Compared with the FAS, participants with mJSW of 2 to 4 mm without widespread pain had improved effect sizes at week 12 and 24.
According to the researchers, “These increased point estimates and confidence intervals may help to improve power calculations and create more homogenous populations to test new therapies.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
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Reference
Kennedy S, Swearingen C, Tambiah J, Clauw D, Conaghan PG. Subject enrichment criteria for phase 3 studies of lorecivivint (SM04690), a potential disease-modifying knee osteoarthritis drug: a post hoc study on the effects of baseline comorbid pain and joint space width on patient-reported outcomes. Presented at: ACR Convergence 2021; November 3 to 10, 2021. Abstract 1308.
