A randomized, double blind, placebo-controlled pilot study to assess the efficacy of erenumab in individuals with temporomandibular disorder

Abstract

Background: Erenumab has proven efficacious in treating migraine headache. Temporomandibular disorder (TMD) is a painful disorder which has high co-occurrence rates with migraine. We hypothesized that erenumab-aooe may also be beneficial in reducing pain in TMD-related myalgia. Methods: This phase II randomized placebo-controlled clinical trial evaluated the safety and efficacy of the off-label use of erenumab in reducing TMD-related pain. The TMD diagnosis was established using the Diagnostic Criteria for Temporomandibular Disorders. The primary outcome was pain interference as assessed by the 0-to-10-point Brief Pain Inventory (BPI). Secondary outcomes were depression, anxiety and somatic symptoms; jaw function; and percent of days taking pain medication. Subjects were randomized at baseline to receive either erenumab 140 mg or placebo administered subcutaneously every 4 weeks for a total of five treatments. Outcome assessments were conducted at baseline, 4, 8, 12, 16, 20 and 24 weeks. Results: Thirty subjects were enrolled with 15 randomized to each treatment group. Baseline pain was mild (BPI interference of 2.19; BPI severity of 2.95). There were no significant treatment effects at any time points with the between-group BPI interference at 24 weeks being -0.19 (95% confidence interval -1.94 to 1.56; p = 0.82). The outcomes were similar between erenumab and placebo for all outcomes except the Patient Health Questionnaire 4-item scale (PHQ-4) which showed that depression/anxiety symptoms were modestly worse (p = 0.03) in the erenumab group. Five participants withdrew during the trial (4 in erenumab arm, 1 in placebo arm). Conclusions: Erenumab was not efficacious in reducing TMD myalgic pain in this phase II trial of 30 subjects with relatively mild pain.