Highlights from

EULAR 2019

European Congress of Rheumatology

Madrid 12-15 June 2019

Efficacy and safety of subcutaneous tanezumab: a phase 3 study

Subcutaneous tanezumab 5 mg improved all co-primary endpoints of pain, physical function, and patient's global assessment of osteoarthritis (PGA-OA). A lower dose of 2.5 mg improved pain and physical function, but did not achieve significance on PGA-OA. Reported adverse events (AEs) were consistent with previous studies of tanezumab in OA. Similar numbers of total joint replacements were reported across groups, though overall joint safety events were more frequent with tanezumab than placebo.

Tanezumab, a human monoclonal antibody against nerve growth factor (NGF), is in clinical development for the treatment of osteoarthritis (OA) pain. Dr Francis Berenbaum et al. (Sorbonne University, France) evaluated the efficacy and safety of subcutaneous tanezumab treatment in patients with moderate-to-severe OA pain who have not responded to or cannot tolerate conventional analgesics.

This randomised, double-blind, placebo-controlled phase 3 trial included a total of 849 patients from Europe and Japan. Patients were randomised over 3 treatment groups, receiving subcutaneous tanezumab 2.5 (n=283) or 5 mg (n=284), or placebo (n=282) at baseline, week 8, and week 16. Co-primary endpoints were changes from baseline in WOMAC Pain Index, WOMAC Physical Function Index, and Patient Global Assessment of OA (PGA-OA) scores at week 24.

Tanezumab 5 mg met all co-primary endpoints, whereas tanezumab 2.5 mg did not meet the efficacy criteria (PGA-OA). The incidence of AEs and discontinuations due to AEs were similar across groups, but serious AEs occurred more frequently in tanezumab groups compared with placebo. The only AE occurring in 3% of patients in any group, and more frequently (>1% difference) in both tanezumab groups relative to placebo, was OA. Total joint replacements occurred in 6.7%, 7.8%, and 7.0% of patients in the placebo, tanezumab 2.5 mg, and tanezumab 5 mg groups, respectively. Other (pre-specified) joint safety events such as rapidly progressive OA, subchondral insufficiency fracture, and primary osteonecrosis occurred in 0% and 2.5% of patients in the placebo and tanezumab groups, respectively. All joint safety events were mostly adjudicated as a normal progression of OA.

  1. Berenbaum F, et al. Abstract LB0007, EULAR 2019

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