medwireNews: Phase III study findings reported at the EULAR 2019 congress in Madrid, Spain, provide support for the use of tanezumab, a monoclonal antibody against nerve growth factor, to improve pain and physical function among individuals with osteoarthritis (OA).
The trial included 849 participants with moderate-to-severe disease and an inadequate response to standard analgesics who were randomly assigned to receive subcutaneous tanezumab at a dose of 5.0 mg or 2.5 mg at baseline, week 8, and week 16, or to receive placebo.
Francis Berenbaum (Sorbonne Université, Paris, France) told attendees at the late-breaking abstract session that the 284 patients treated with tanezumab 5 mg experienced a significantly greater improvement in the three coprimary endpoints of WOMAC pain, WOMAC physical function, and patient global assessment for OA (PGA-OA) scores from baseline to week 24 than the 282 given placebo.
Specifically, the least squares (LS) mean decrease in WOMAC pain score was 2.85 points for participants in the tanezumab 5.0 mg group compared with 2.24 for those given placebo, while the LS mean reductions in WOMAC physical function and PGA-OA scores were 2.82 versus 2.11 and 0.90 versus 0.72 points, respectively.
Berenbaum noted that there was a significantly greater decrease in WOMAC pain and physical function scores among the 283 patients treated with the 2.5 mg dose of tanezumab versus placebo (2.70 vs 2.24 and 2.70 vs 2.11, respectively), but there was no significant difference in PGA-OA score reductions between the two groups (0.82 vs 0.72).
He said that there was a “strong difference” in the proportion of patients who experienced at least a 30% or 50% improvement in WOMAC pain scores between the tanezumab and placebo groups. For example, 30% response rates were 68.7% in the tanezumab 5.0 mg group and 65.6% in the 2.5 mg group versus 56.6% in the placebo arm, and the corresponding 50% response rates were 47.9% and 45.2% versus 33.8%.
The presenter reported that the safety profile of tanezumab in the trial was “consistent with previous studies of tanezumab in OA.”
Adverse events (AEs) occurred in 57.0% of participants given tanezumab 5.0 mg, 53.0% of those given the 2.5 mg dose, and 55.0% of those in the placebo arm. Rates of serious AEs were 3.2%, 2.8%, and 1.1%, respectively, and the corresponding proportions of patients who discontinued treatment due to AEs were 1.4%, 1.1%, and 2.5%.
The most frequently occurring AE was arthralgia, reported by 8.1%, 9.5%, and 12.1% of patients in the 5.0 mg, 2.5 mg, and placebo groups, respectively, followed by nasopharyngitis, back pain, and headache.
Berenbaum said that the only AE that occurred in at least 3% of all study participants and was more common among those given tanezumab versus placebo was OA, with rates of 4.6% and 3.2% in the tanezumab 5.0 mg and 2.5 mg groups, respectively, compared with 1.8% for those given placebo. The likelihood of requiring total joint replacement over a total 48 weeks of follow-up was comparable across the three groups, at rates of 7.0%, 7.8%, and 6.7%, respectively.
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