General Safety and Tolerability of Subcutaneous Tanezumab for Osteoarthritis: A Pooled Analysis of Three Randomized, Placebo-Controlled Trials.
Arthritis Care Res (Hoboken)
; 74(6): 918-928, 2022 06.
Article
en En
| MEDLINE
| ID: mdl-33973384
OBJECTIVE: This pooled analysis of 3 randomized, placebo-controlled trials (16-24 week treatment and 8-24 week follow-up) assessed safety of subcutaneous tanezumab (2.5-10 mg every 8 weeks) in 1,840 patients with hip or knee osteoarthritis. METHODS: 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, and pathologic 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 plus follow-up period were 0% for placebo and 0.5-3.2% for tanezumab 2.5-5 mg (5 mg was statistically greater than placebo); total joint replacement rates with tanezumab (5.9-7.0%) were not significantly different from placebo (4.5%). Rates of TEAEs of APS (predominantly paresthesia and hypoesthesia) 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). CONCLUSION: Tanezumab was generally well tolerated. TEAEs of APS (mostly mild and transient) and joint safety events were infrequent but more common with tanezumab than placebo. A tanezumab dose of 2.5 mg demonstrated a more favorable safety profile than higher doses.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Osteoartritis de la Cadera
/
Artroplastia de Reemplazo
/
Osteoartritis de la Rodilla
Tipo de estudio:
Clinical_trials
/
Systematic_reviews
Límite:
Humans
Idioma:
En
Revista:
Arthritis Care Res (Hoboken)
Asunto de la revista:
REUMATOLOGIA
Año:
2022
Tipo del documento:
Article
País de afiliación:
Francia
Pais de publicación:
Estados Unidos