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            MIMS醫藥資訊2020-03-02 20:16:41人已圍觀

            The antinerve growth factor (anti-NGF) fasinumab delivers significant analgesic effects in patients experiencing moderate-to-severe pain from osteoarthritis (OA), including those benefitting little from a previous analgesic, according to the results of a phase IIB/III trial.

            The study randomized 419 patients (mean age, 60.6 years; 64.6% female) with moderate‐to‐severe OA pain (knee or hip) and history of inadequate response or intolerance to analgesics to receive fasinumab 1 mg, 3 mg, 6 mg, 9 mg, or placebo every 4 weeks over 16 weeks, with 20 weeks of post-treatment follow-up (weeks 16-36). A total of 342 patients completed the study.

            At week 16, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores significantly improved from baseline in all fasinumab dose groups than in the placebo group (least square mean [LSM] difference, -0.78 to -1.40). [Arthritis Rheumatol 2019; doi:10.1002/art.41012]

            There were parallel reductions observed in WOMAC physical function subscale scores (LSM difference, -1.10 to -1.4) and patient global assessment (PGA; >30% improvement with 1 mg and 9 mg doses vs placebo: P=0.0132 and P=0.008, respectively).

            Treatment-emergent adverse events (TEAEs) - including musculoskeletal, nervous system, gastrointestinal, and vascular disordersduring - the treatment period occurred in 209 patients (62%) in the combined fasinumab dose groups and 45 patients (54.9%) in the placebo group, of which 14 and one patientsin the respective groups discontinued treatment.

            During the 20-week follow-up (week 16-36), TEAE rates were higher in the combined fasinumab group than in the placebo group (48% vs 38%), although there was no significant difference in the incidence of serious TEAEs (6% vs 5%).

            Arthropathies developed in 25 patients overall: 24 in the combined fasinumab dose groups and one in theplacebo group. These incidences were dose‐dependent, occurring in two patients who received the lowest dose of the study drug and in 10 who received the highest dose. Most (16/25) were detected by scheduled radiographs and not based on symptoms. Destructive arthropathy (1/337 treated) occurred in one patient in the 6 mg dose group.

            "Fasinumab was well tolerated by most patients, with a clear dose-dependent increase in joint-related abnormalities. The observation that efficacy at lower doses was similar to that of higher doses, but with lower rates of arthropathy, demands that future studies explore the benefit-risk at these lower doses," the investigators said.

            "To our knowledge, this is the first study of an NGF inhibitor to incorporate routine, prospective, intense radiological joint assessment using both radiographs and MRI, to comprehensively document the occurrence of nonsymptomatic, as well as symptomatic arthropathies," they continued, noting that treatment-related arthropathies have tempered enthusiasm for anti-NGF agents despite their promising efficacy.

            Taken together, the present data indicate that fasinumab provides a substantial degree of analgesia, with the analgesic effect not seemingly dependent on dose level, in an important, previously unaddressed patient population - those with moderate-to-severe pain from OA who have not experienced relief from prior analgesics, the investigators concluded.



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