Real-world long-term efficacy and safety of erenumab in adults with chronic migraine: a 52-week, single-center, prospective, observational study

Abstract

Background Clinical trials have shown that erenumab is effective and well-tolerated for the preventive treatment of chronic migraine. To extend the results from clinical trials, we assessed the real-world efficacy and safety of erenumab in patients with chronic migraine from the outpatient clinic at the Danish Headache Center. Methods A 52-week, single-center, prospective, observation study of erenumab in adults with chronic migraine who are eligible for treatment with monoclonal antibodies against CGRP or its receptor in Denmark. The primary outcome was defined as proportion of patients who achieved ≥ 30% reduction in monthly migraine days (MMDs) from baseline to weeks 9–12. Results A total of 300 adult patients with chronic migraine were enrolled and received at least one dose of erenumab. At baseline, the mean (SD) number of monthly headache days was 23 ± 4.9 and mean number of MMDs was 16.8 ± 6.4. Of 300 enrolled patients, 273 (91.0%) patients completed 12 weeks of treatment, and 119 (39.7%) completed 52 weeks of treatment. The number of patients who achieved ≥ 30% reduction in MMDs from baseline to weeks 9–12 was 195 (71.4%) of 273 patients. Sustained ≥ 30% reduction in MMDs at all assessment periods throughout the 52-week treatment period was achieved by 102 (34%) of 300 patients. Adverse events occurred in 220 (73.3%) out of 300 patients. The most common adverse event was constipation. Treatment discontinuation due to lack of tolerability occurred in 41 (13.7%) patients. Conclusions Among adult patients with chronic migraine and previous failure of medications for migraine prevention, erenumab was found to be effective and well-tolerated.

Clinical evaluation of super-responders vs. non-responders to CGRP(-receptor) monoclonal antibodies: a real-world experience

“…Real-world data with the use of CGRP(-R) mAbs in clinical practice show similar findings. About half of CM patients have a 50% reduction of MMD after three months of treatment [ 15 , 16 ]. At the same time, up to one-third of patients do not respond to mAbs treatment, while 20% have a very high benefit with a reduction of ≥ 75% in MMD along a tremendous improvement of quality of life.…”

Effluvium and alopecia associated with monoclonal calcitonin gene‐related peptide antibody use

“…Also, post‐marketing clinical studies or reports did not reveal a significant rate of effluvium or alopecia in patients using monoclonal CGRP antibodies 1 . To the best of our knowledge, we also did not find a case report on effluvium associated with the use of monoclonal CGRP antibodies in medical databanks but alopecia was reported in real‐world studies on monoclonal CGRP antibodies 2 . However, when we started treating patients with migraine at the end of 2018 with monoclonal CGRP antibodies in our supraregional tertiary headache clinic, we observed a few patients reporting hair loss after onset of treatment.…”

New migraine prophylactic drugs: Current evidence and practical suggestions for non-responders to prior therapy

“…To date, no real-world studies of eptinezumab and gepants have been published. Real-world studies (13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) assessed the efficacy of erenumab using the following parameters: mean reduction in monthly headache days (MHDs), monthly migraine days (MMDs), monthly acute medication days (AMDs) and the proportion of patients reporting a !50% reduction in MMD in patients with EM and CM (Table 2). The treatment duration ranged from two to 12 months, with a commercially available dose (i.e., erenumab 70 or 140 mg every four weeks).…”

“…Treatment interruption due to lack of effectiveness and adverse events was 0%–22% and 0%–12%, respectively. Real-world studies of erenumab reported that 22%–83% of patients converted from CM to EM (16,17,19,27,30), and one subgroup analysis showed a higher rate of conversion among patients with difficult-to-treat migraine with a long history of CM and multiple prior unsuccessful prophylactic treatments, including BTA (31).…”