CGRP blockade by galcanezumab was not associated with reductions in signs and symptoms of knee osteoarthritis in a randomized clinical trial

Y. Jin*, C. Smith, D. Monteith, R. Brown, A. Camporeale, T. A. McNearney, M. A. Deeg, E. Raddad, N. Xiao, A. de la Peña, A. J. Kivitz, T. J. Schnitzer

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

Abstract

Objective: This study tested whether galcanezumab, a humanized monoclonal antibody with efficacy against migraine, was superior to placebo for the treatment of mild or moderate osteoarthritis (OA) knee pain. Method: In a multicenter, double-blind, placebo- and celecoxib-controlled trial, patients with moderate to severe OA pain were randomized to placebo; celecoxib 200 mg daily for 16 weeks; or galcanezumab 5, 50, 120, and 300 mg subcutaneously every 4 weeks, twice. The primary outcome was change from baseline at Week 8 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore measured by 100 mm visual analog scale (VAS). The trial was considered positive if ≥1 dose of galcanezumab demonstrated ≥95% Bayesian posterior probability of superiority to placebo and ≥50% posterior probability of superiority to placebo by ≥9 mm. A planned interim analysis allowed termination of the study if posterior probability of superiority to placebo by ≥9 mm was ≤5%. Secondary endpoints included WOMAC function subscore and Patient Global Assessment (PGA) of OA. Safety and tolerability were also assessed. Results: The study was terminated after interim analysis suggested inadequate efficacy. Celecoxib significantly reduced WOMAC pain subscore compared with placebo [−12.0 mm; 95% confidence interval (CI) −23 to −2 mm]. None of the galcanezumab arms demonstrated clinically meaningful improvement (range: 1.5 to −5.0 mm) or met the prespecified success criteria. No improvement in any secondary objective was observed. Galcanezumab was well tolerated by OA patients. Conclusions: This study failed to demonstrate sufficient statistical evidence that galcanezumab was efficacious for treating OA knee pain. Study identification: NCT02192190.

Original languageEnglish (US)
Pages (from-to)1609-1618
Number of pages10
JournalOsteoarthritis and Cartilage
Volume26
Issue number12
DOIs
StatePublished - Dec 2018

Keywords

  • CGRP
  • Clinical trial
  • Knee pain
  • Monoclonal antibody
  • Osteoarthritis

ASJC Scopus subject areas

  • Rheumatology
  • Biomedical Engineering
  • Orthopedics and Sports Medicine

Fingerprint Dive into the research topics of 'CGRP blockade by galcanezumab was not associated with reductions in signs and symptoms of knee osteoarthritis in a randomized clinical trial'. Together they form a unique fingerprint.

Cite this