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- W2006801501 abstract "Fulranumab (JNJ-42160443) is a fully human recombinant monoclonal antibody that neutralizes the biologic actions of human nerve growth factor, which contributes to persistent pain. We report the 12-week efficacy results from an ongoing 104-week multicenter, phase 2, randomized, double-blind, placebo-controlled, trial designed to evaluate the analgesic effect of several doses of adjunctive fulranumab therapy in patients with chronic low back pain (cLBP) inadequately controlled with current pain therapy (NSAIDs, opioids). Long-term safety and tolerability are also being assessed. Patients (18 to 80 years; N=389) with inadequately controlled moderate-to-severe cLBP were randomized to receive subcutaneous injections every 4 weeks in one of 5 parallel treatment groups: placebo or fulranumab 1mg, 3mg, 3mg after a 6mg loading dose, or 10mg every 4 weeks. 385 patients (median age: 53 years; 54% women) received at least one injection of study medication (ITT population). Fulranumab 10mg was not significantly different from placebo treatment in change in average pain score from baseline to week 12 (primary efficacy measure) (between-group difference in least square mean change: -0.1; 95% CI:-0.79, 0.49; p=0.65). Based on a prespecified step-down multiple comparison procedure, the differences from placebo for all lower fulranumab doses were also nonsignificant (unadjusted p-values ≥ 0.46). Results for secondary efficacy parameters were consistent with the primary outcome. The most common adverse events (>5% total fulranumab group) during the 12-week double-blind efficacy phase for fulranumab-treated patients were diarrhea (7%), headache (7%), paraesthesia (6%), nasopharyngitis (6%), and upper respiratory tract infection (6%). Neurologic adverse events (primarily paraesthesia and hypoaesthesia) were more frequent in the fulranumab 3mg and higher dose groups (12% to 13%) than placebo and fulranumab 1mg groups (5%). Fulranumab did not demonstrate efficacy versus placebo in patients with cLBP, but was generally well-tolerated. Funded by Johnson & Johnson Pharmaceutical Research & Development, LLC." @default.
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- W2006801501 date "2011-04-01" @default.
- W2006801501 modified "2023-10-14" @default.
- W2006801501 title "Efficacy, safety, and tolerability of fulranumab in treatment of patients with moderate-to-severe, chronic low back pain" @default.
- W2006801501 doi "https://doi.org/10.1016/j.jpain.2011.02.217" @default.
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