MADRID — In “difficult-to-treat” patients with osteoarthritis who have a history of insufficient pain relief or intolerance to standard-of-care analgesics or opioids, the monoclonal antibody tanezumab effectively reduces pain and increases function, new phase 3 research indicates.
Findings of a 24-week study with a 24-week follow-up, were presented by Francis Berenbaum, MD, PhD, from Sorbonne University in Paris, during a late-breaking clinical trials session hereat the European League Against Rheumatism (EULAR) 2019 Congress.
“I think this is the first time we have a new target in the field of analgesics that could be taken as an opioid-sparing drug,” said Berenbaum. “Having this new opportunity should really be put into the balance when assessing the benefit–risk of this drug.“
Tanezumab is a monoclonal antibody that selectively targets and inhibits nerve growth factor as a pain treatment.
The randomized, double-blind, placebo-controlled study involved 849 patients in Europe and Japan with moderate to severe osteoarthritis pain of the knee or hip and a history of insufficient pain relief, intolerance to standard-of-care analgesics, or an unwillingness to take opioids.
Participants received subcutaneous tanezumab — 2.5 mg or 5 mg — or placebo at baseline, week 8, and week 16. Berenbaum and his team assessed the change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function scores and in Patient’s Global Assessment of Osteoarthritis (PGA-OA) scores in all participants.
Tanezumab 5 mg improved scores for all coprimary end points, but the 2.5 mg dose fell short in PGA-OA measures.
Serious adverse events occurred more frequently with tanezumab than with placebo. The two deaths in the 5 mg group were considered to be unrelated to treatment.
Total joint replacements occurred in roughly 7% of all three groups, “which is an important notion for the clinical consequences,” Berenbaum reported.
However, “the patients most likely to benefit include those considered too young for joint replacement surgery or those who simply don’t want to undergo joint replacement,” he added.
“Tanezumab clearly had a benefit,” said John Isaacs, MBBS, PhD, from Newcastle University in Newcastle Upon Tyne, United Kingdom, who is chair of the EULAR abstract selection committee.
“Again, we did see a few cases of progressive osteoarthritis. It’s still not quite clear why that happens,” Isaacs told Medscape Medical News. “It’s down to the regulators to see if the risk–benefit is in favor. Like all effective drugs, it has side effects.”
Audience members appeared to welcome an additional strategy to tackle severe osteoarthritis pain.
The study was funded by Eli Lilly and Pfizer. Berenbaum has received grant or research support through his institution from TRB Chemedica, MSD, and Pfizer; is a consultant for Novartis, MSD, Pfizer, Lilly, UCB, AbbVie, Roche, Servier, Sanofi-Aventis, Flexion Therapeutics, Expanscience, GSK, Biogen, Nordic, Sandoz, Regeneron, Gilead, Bone Therapeutics, Regulaxis, and Peptinov; is a paid instructor for Sandoz; and is a member of the speakers bureau for Novartis, MSD, Pfizer, Lilly, UCB, AbbVie, Roche, Servier, Sanofi-Aventis, Flexion Therapeutics, Expanscience, GSK, Biogen, Nordic, Sandoz, Regeneron, and Gilead. Isaacs is a consultant or has received honoraria and grants for AbbVie, Biogen, Bristol-Myers Squibb, Celltrion, Eli Lilly, Gilead, Janssen, Merck, Pfizer, and Roche.
European League Against Rheumatism (EULAR) Congress 2019: Abstract LB0007. Presented June 15, 2019.