Tanezumab for Patients with Osteoarthritis of the Knee: A Meta-Analysis

Abstract

ObjectiveTanezumab is a new therapeutic intervention for patients with osteoarthritis (OA) of the knee. We performed the present meta-analysis to appraise the efficacy and safety of tanezumab for patients with knee OA.MethodsWe systematically searched randomized controlled trials from PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL). The primary outcomes were mean change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, the WOMAC physical function and patient's global assessment (PGA). Outcomes were reported as the standard mean difference (SMD) or relative risk (RR) with 95% confidence interval (CI). We assessed the pooled data using a random-effects model.ResultsOf the identified studies, four were eligible and were included in this meta-analysis (N = 1839 participants). Compared with the placebo groups, tanezumab yielded a significant reduction in mean change in the WOMAC pain (SMD = 0.51, 95% CI 0.34 to 0.69, P<0.00001), the WOMAC physical function (SMD = 0.56, 95% CI 0.38 to 0.74, P<0.00001) and PGA (SMD = 0.34, 95% CI 0.22 to 0.47, P<0.00001). There was no significant difference in serious adverse events (RR = 1.06, 95% CI 0.59 to 1.92, P = 0.84) between the tanezumab and placebo groups. Tanezumab significantly increased discontinuations due to adverse events (RR = 2.89, 95% CI 1.59 to 5.26, P = 0.0005), abnormal peripheral sensations (RR = 3.14, 95% CI 2.12 to 4.66, P<0.00001), and peripheral neuropathy (RR = 6.05, 95% CI 2.32 to 15.81, P = 0.0002).ConclusionTanezumab can alleviate pain and improve function for patients with OA of the knee. However, considering the limited number of studies, this conclusion should be interpreted cautiously and more clinical randomized controlled trials are needed to verify the efficacy and safety of tanezumab for OA of the knee.

An observational analysis of discontinuation and non-publication of osteoarthritis trials

“…For instance, the FDA hold on tanezumab was listed as the most common response to trial discontinuation. The hold originated from safety data regarding adverse reactions in patients taking the drug 27 . The hold has since been lifted, and investigations into the drug's safety and efficacy are ongoing.…”

Pain and Inflammation. Part 2. The Analgesic Potential of Anti-Inflammatory Drugs

“…Однако проведенные исследования, к сожале-нию, обнаружили и ряд недостатков танезумаба, кото-рые в итоге приостановили его регистрацию и начало применения в реальной практике. Оказалось, что новое лекарство вызывает серьезные НР -появление сенсор-ных симптомов (парестезия и гипестезия), в ряде случа-ев появление или ухудшение полиневропатии, а также ускорение прогрессирования ОА, которое в отдельных случаях потребовало проведения эндопротезирования [61][62][63].…”

Dissatisfaction with management of musculoskeletal pain: A global problem and methods of its solution

“…Но в этих работах выявлен и ряд недостатков танезумаба, что в итоге приостановило его регистрацию и начало применения в реальной практике. Это серьезные НР: появление сенсор-ных симптомов (парестезия и гипестезия), в некоторых слу-чаях развитие полиневропатии, а также ускорение прогрес-сирования ОА, которое у отдельных пациентов потребовало выполнения эндопротезирования [35][36][37].…”