Lorecivivint yields improved patient-reported outcome scores in knee OA
ATLANTA — A 0.07 mg intra-articular injection of lorecivivint, a Wnt pathway inhibitor, was associated with improvements in patient-reported pain and function compared with placebo, according to findings presented in a poster at ACR/ARP 2019.
Yusuf Yazici, MD, chief medical officer of Samumed and clinical associate professor of medicine at the New York University School of medicine, and colleagues conducted a post-hoc analysis of lorecivivint compared with placebo from Samumed's 24-week phase 2b trial in cohort of 635 patients with knee osteoarthritis.
The primary endpoints for patient-reported outcomes were assessed in terms of change in numerical rating scale (NRS) pain, WOMAC pain, WOMAC function and Patient Global Assessment. The researchers targeted improvements of 30%, 50%, or 70% in these outcomes.
“As we know from rheumatoid arthritis criteria, ACR 20, 50, and 70 response, we are evaluating patients based on whether they reached the 20%, 50%, or 70% response or not,” Yazici told Healio Rheumatology in an interview. “We looked at our data in that light. If the patient is showing an adequate response, we will keep them on the same treatment. If they had a response but it is not really enough, in the case of our drug, we will give them another injection. It gives you a more clear picture.”
Eligible participants had been given a single, 2 mL, intra-articular injection of 0.03 mg, 0.07 mg, 0.15 mg, or 0.23 mg of lorecivivint, or placebo. Yazici presented week 12 results for the 0.07 mg dose.
Results showed that the 0.07 mg dose was significantly more likely than placebo to yield a 30% response in NRS pain (OR = 2.47; 95% CI, 1.45-4.19) and WOMAC function (OR = 1.85; 95% CI, 1.1-3.12). “Another way to look at this data is when patients ask, “What are my chances of responding?”” Yazici said. “The odds ratios give us that information.”
The 0.07 mg dose also bested placebo in achieving a 50% response in WOMAC pain (OR = 1.79; 95% CI, 1.06-3.03) and Patient Global Assessment (OR = 2.28; 95% CI, 1.25-4.16).
In terms of 70% improvements from baseline, lorecivivint was associated with numerical, but not statistically significant, improvements in all four parameters compared with placebo.
“We collect data on these pain and function outcomes because physicians want to know about them,” Yazici said. “But it seems from our discussion, because we are able to collect information on pain NRS daily, and then we average it for the week, that was a good way of helping patients differentiate their pain.” – by Rob Volansky
Yazici Y. Abstract #1327. The novel, intra-articular CLK/DYRK1A inhibitor lorecivivint (LOR; SM04690), which modulates the Wnt pathway, improved responder outcomes in subjects with knee osteoarthritis: A post hoc analysis from a phase 2b trial. Presented at: American College of Rheumatology/Association of Rheumatology Professionals Annual Meeting; Nov. 9-13, 2019; Atlanta.
Disclosure: Yazici reports being an employee of Samumed LLC.