Study finds, Safety and Tolerability of Subcutaneous Tanezum
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
This pooled analysis of 3 randomized, placebo-controlled trials (16-24 week treatment; 8-24 week follow-up) assessed safety of subcutaneous tanezumab (2.5-10 mg every 8 weeks) in 1840 patients with hip or knee osteoarthritis.

Overall treatment-emergent adverse events (TEAEs) and TEAEs of abnormal peripheral sensation (APS) were prospectively assessed in 3 trials. Joint safety events (primary osteonecrosis, rapidly progressive osteoarthritis [RPOA], subchondral insufficiency fracture, pathological fracture; adjudicated by an independent expert committee) and TEAEs potentially associated with sympathetic neuropathy were prospectively assessed in 2 trials.

Results:
--During the treatment period, overall TEAE rates were 51.7% for placebo and 39.5-54.8% for tanezumab 2.5-10 mg; treatment discontinuation rates were 2.0% for placebo and 0%–1.3% for tanezumab.

--Rates of composite joint safety events (predominantly RPOA-type 1) over the treatment + follow-up period were 0% for placebo and 0.5-3.2% for tanezumab 2.5-5 mg; total joint replacement rates with tanezumab were not significantly different from placebo.

--Rates of TEAEs of APS (predominantly paraesthesia and hypoaesthesia) were 2.2% for placebo and 3.2-12.8% for tanezumab 2.5-10 mg.

--Rates of TEAEs potentially associated with sympathetic neuropathy (predominantly bradycardia and orthostatic hypotension) were 0.8% for placebo and 0.5-2.8% for tanezumab 2.5-5 mg (exposure-adjusted rates were not significantly different from placebo).

Tanezumab was usually well tolerated, in conclusion. APS TEAEs (mostly mild and transient) and joint safety incidents were uncommon with tanezumab but more common than placebo. The safety profile of tanezumab 2.5 mg was found to be better than that of higher doses.

Source: https://onlinelibrary.wiley.com/doi/10.1002/acr.24637?af=R
Like
Comment
Share