Abstract Details

Title Analgesic Efficacy of Fulranumab in Patients with Painful Diabetic Peripheral Neuropathy in a Randomized, Placebo-Controlled, Double-Blind Study

Topic Peripheral Nerve

Presentation(s) S58 - (-)

Poster/Presentation
Number 002

Objective

Background NGF antibodies offer a potential treatment option in DPN.

Design/Methods Multicenter, phase 2, placebo-controlled study (initiated Oct. 2009) with a 12-week double-blind (DB) efficacy-, 40-week DB safety extension-, and 52-week open-label safety extension phase. Patients with moderate to severe pain, stratified by concomitant treatment for neuropathic pain (yes/no), were randomized (3:2:2:3) to receive either placebo or fulranumab (1 mg-, 3 mg-, or 10 mg fulranumab; every 4 weeks [Q4wk] subcutaneously).

Results Due to US FDA clinical hold, only 77 of planned 200 patients were enrolled: 62 (81%) patients (55.8% men; 81.8% white; mean [SD] age 58.7 [9.48] years) completed the DB efficacy phase. Change in 7-day average of daily pain intensity score from baseline to end of 12 week DB efficacy phase (primary endpoint) showed a positive dose response (p=0.014, one-sided). At DB efficacy endpoint, the pair-wise comparison between 10 mgQ4wk dose to placebo was significant (nominal p=0.04, two-sided). Least square (LS) means differences (95% CI) in change from baseline in average pain intensity scores vs placebo were: fulranumab 1mgQ4wk, 0.1 (-1.26; 1.36); 3mgQ4wk, -0.6 (-1.98; 0.74); and 10 mgQ4wk, -1.2 (-2.44; -0.06). 30% responder rates (?30% improvement in average pain intensity score) at DB efficacy endpoint were: placebo, 21%; 1mgQ4wk, 44%; 3mgQ4wk, 43%; and 10 mgQ4wk, 61%. Multiple secondary efficacy endpoints showed dose-related improvement trends. Most common (?5 patients) adverse events for total fulranumab-treated patients (n=53) vs placebo (n=24) were: peripheral oedema (11% vs 0%), arthralgia (11% vs 13%), and diarrhoea (9% vs 8%). No cases of joint replacement or deaths were reported during the study.

Conclusions Despite early study termination, fulranumab treatment resulted in dose-dependent efficacy and was generally well tolerated in this study.

Authors/Disclosures
PRESENTER	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Elizabeth Nowak	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
John Thipphawong, MD (JANSSEN)	No disclosure on file

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