No ‘Wearing-Off Effect’ Seen with Fremanezumab in the Real-World: Retrospective, Claims-Based Analysis of Migraine-Related Healthcare Resource and Acute Medication Use
Jessica Ailani1, Handing Xie2, Maurice Driessen3, Mario Ortega4, Yitong Wang2, Verena Ramirez Campos2, Sangtaeck Lim2
1Georgetown University Hospital, 2Teva Branded Pharmaceutical Products R&D, Inc, 3Teva Pharmaceutical Industries Ltd, 4Teva Pharmaceuticals
Objective:

To assess weekly patterns in migraine-related healthcare resource use (HCRU) and acute medication use, as proxy for wearing-off with fremanezumab, in US adult migraine patients.

Background:

Wearing-off is the phenomenon whereby clinical symptoms return/worsen before the next scheduled treatment dose. Post-hoc data showed no evidence of wearing-off with monthly and quarterly dose fremanezumab; no respective real-world data are available.

Design/Methods:

This retrospective, observational US claims database analysis included adult migraine patients with ≥2 fremanezumab claims in monthly treatment cycles. The proportions of patients with ≥1 migraine-related HCRU (inpatient, emergency room, outpatient visit or ≥1 migraine-related acute medication claim were descriptively assessed at Weeks 1, 2, 3, and 4 of Cycles 1, 3, 6, and 12. Confidence intervals (CI) at 95% were calculated; overlapping CIs indicated no statistically significant trends in the week-to-week outcome values within each cycle, indicating no wearing-off. Sensitivity analysis examined weekly HCRU and acute medication use during the first 24 cycles.

Results:
During all assessed monthly dosing cycles (N=3217), there were no significant trends indicating wearing-off in migraine-related HCRU or acute medication use. In Cycle 1, the 95% CIs for patients with ≥1 migraine-related outpatient visit at Weeks 1, 2, 3, and 4 overlapped: [5.41%, 7.28%], [4.56%, 6.29%], [5.38%, 7.24%] and [4.93%, 6.73%] respectively. Similarly, 95% CIs for patients with ≥1 migraine-related triptan use were [5.14%, 6.97%], [4.69%, 6.45%], [4.56%, 6.29%] and [5.72%, 7.64%]. Similar trends were observed across Cycles 3, 6, and 12 for all outcomes. Notably, outpatient visits decreased during Cycle 3. Sensitivity analysis confirmed there were no significant trends in outcome values across Cycles 1–24. Quarterly dosing results showed similar trends. 
Conclusions:

Over monthly dosing cycles of fremanezumab, no increases in migraine-related HCRU and acute medication use were seen, representing no evidence of wearing-off with fremanezumab and confirming post-hoc findings.

10.1212/WNL.0000000000203473