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

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.

CLINICAL TRIAL REGISTRATION: The study was registered in clinicaltrials.gov (ID: NCT04884763).