Following publication of the original article , the authors notified us of some misreported data due to the publication of the EVOLVE-2 trial (Cephalalgia. 2018;38:1442-1454), which substantially changed the level of evidence of galcanezumab for the prevention of episodic migraine. All changes are marked in bold and with red in Figure 1 and Figure 2. Please note that the final recommendations remain unchanged. Reference #51 was added: Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim B-K, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38:1442-1454. Please find below the updated text, tables, and figures. Results We identified 29 studies eligible to be considered in the present guidelines (Fig. 1) [23-51]. Fifteen of the selected studies (Tables 1 and 2) were phase II or III randomized clinical trials (RCTs) reporting data on safety or efficacy of the CGRP mAbs [26,27,31-36,41-45,50,51]; 14 additional studies were post-hoc or pooled analyses from the RCTs, open label-extension of the RCTs, or open label studies [23-25,28-30,37-40,46-49]. Risk of bias summary for the selected studies is reported in Fig. 2. Certainty assessment of outcomes for studies in EM and CM is reported in Tables 3 and 4. Recommendations related to the use of CGRP mAbs for prevention of EM and CM are reported in Table 5. PICO question 1: In patients with EM, is preventive treatment with CGRP mAbs as compared to placebo, effective and safe? Population: patients with EM Intervention: any preventive CGRP mAb Comparison: placebo Outcome: reduction in days of migraine or headache, reduction in the use of acute attack medication, improvement in function, responder ratio (patients with > 50% reduction in migraine or headache days), serious adverse events (SAEs), mortality (grade of importance: critical) Analysis of evidence We found 15 eligible studies which evaluated whether treatment with CGRP mAbs as compared to placebo is effective and safe [26,27,31-36,41-45,50,51]. Among the eligible studies one was on eptinezumab , five studies on erenumab [35,36,44,45,50], four studies on fremanezumab [26,27,34,41], and five studies on galcanezumab [31,33,42,43]. One phase IIIb study on erenumab was not included in the PICO question 1 because it included only patients with previous drug failure . Eptinezumab Summary of findings for treatment with eptinezumab quarterly injection compared with placebo for prevention of EM is provided in Table 6. (Figure presented).
|Titolo:||Correction to: European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention (Journal of Headache and Pain (2019) 20:6 DOI: 10.1186/s10194-018-0955-y)|
SACCO, SIMONA (Corresponding)
|Data di pubblicazione:||2019|
|Appare nelle tipologie:||1.1 Articolo in rivista|