Introduction: Raynaud’s phenomenon (RP) is a vasospastic disorder characterized by a digital vascular alteration [1]. In literature there are few case reports suggesting the onset or the exacerbation of RP in patients with migraine, caused by calcitonin gene-related peptide (CGRP) antagonists, the newest class of anti-migraine drug [2]. Aim: To identify a risk of reporting for RP for anti-CGRP drugs using VigiBase Methods: We performed a disproportionality analysis on the World Health Organization (WHO) database (VigiBase ) by calculating the Reporting Odds Ratio (ROR) and Information Component (IC) for all anti-CGRPs, for the single class of mAbs and gepants and for single anti-CGRPs. The ROR and IC were calculated as follow: Cases: all reports with RP events; Non-cases: all reports without RP events; Index: a) all anti-CGRPs (class); b) mAbs (sub-class); c) gepants (sub-class); d) single anti-CGRP; reference: all drugs other than anti- CGRP. The information contained in this abstract does not represent the opinion of Uppsala Monitoring Center or the WHO. Results: We identified 166 drug-event pairs of suspected RP associated with anti-CGRPs in VigiBase . The ICSRs in which a mAb was suspected were 81 erenumab, 52 galcanzeumab, and 28 fremanezumab. Ubrogepant and rimegepant, included in the gepant subclass, are reported with 4 and 5 ICSRs, respectively. Most of the patients were women (146, 88%). Of 166 ICSRs, 76.5% (127 ICSRs) were ‘‘not serious’’ while 23.5% (39) were ‘‘serious’’. The most frequently co-reported events were constipation (11), arthralgia (9) and alopecia and weight increased (8 each one). Triptans are the most reported drugs as suspected/interacting/concomitant. The disproportionality analysis for all anti-CGRP revealed a significant ROR (12.3; ROR025 10.6) and IC (3.5; IC025 3.3). The disproportionality analysis for mAbs sub-class showed a significant ROR (13.3; ROR025 11.4) and IC (3.6; IC025 3.4). Also, the disproportionality analysis for gepants sub-class revealed a significant ROR (n = 8; 4.9; ROR025 2.5) and IC (2.0; IC025 0.8). Each single anti-CGRP had a significant ROR and IC. Conclusion: The disproportionality analysis showed a significant risk of reporting for RP associated with anti-CGRP. Notably, RP is described in patient with migraine. The exact mechanism of how RP and migraine are related is not fully understood, but it may involve CGRP. CGRP could have a protective role in maintaining peripheral blood flow. In this way, some authors suggest that anti-CGRP could activate or exacerbate RP. Further investigations, including observational studies and clinical assessments, are warranted to clarify the role of these drugs.
Raynaud’s Phenomenon Associated with Calcitonin Gene-Related Peptide (CGRP) Antagonists: a Disproportionality Analysis on VigiBase
G Valdiserra;E Cappello;S Ferraro;I Convertino;M Bonaso;M Tuccori
2023-01-01
Abstract
Introduction: Raynaud’s phenomenon (RP) is a vasospastic disorder characterized by a digital vascular alteration [1]. In literature there are few case reports suggesting the onset or the exacerbation of RP in patients with migraine, caused by calcitonin gene-related peptide (CGRP) antagonists, the newest class of anti-migraine drug [2]. Aim: To identify a risk of reporting for RP for anti-CGRP drugs using VigiBase Methods: We performed a disproportionality analysis on the World Health Organization (WHO) database (VigiBase ) by calculating the Reporting Odds Ratio (ROR) and Information Component (IC) for all anti-CGRPs, for the single class of mAbs and gepants and for single anti-CGRPs. The ROR and IC were calculated as follow: Cases: all reports with RP events; Non-cases: all reports without RP events; Index: a) all anti-CGRPs (class); b) mAbs (sub-class); c) gepants (sub-class); d) single anti-CGRP; reference: all drugs other than anti- CGRP. The information contained in this abstract does not represent the opinion of Uppsala Monitoring Center or the WHO. Results: We identified 166 drug-event pairs of suspected RP associated with anti-CGRPs in VigiBase . The ICSRs in which a mAb was suspected were 81 erenumab, 52 galcanzeumab, and 28 fremanezumab. Ubrogepant and rimegepant, included in the gepant subclass, are reported with 4 and 5 ICSRs, respectively. Most of the patients were women (146, 88%). Of 166 ICSRs, 76.5% (127 ICSRs) were ‘‘not serious’’ while 23.5% (39) were ‘‘serious’’. The most frequently co-reported events were constipation (11), arthralgia (9) and alopecia and weight increased (8 each one). Triptans are the most reported drugs as suspected/interacting/concomitant. The disproportionality analysis for all anti-CGRP revealed a significant ROR (12.3; ROR025 10.6) and IC (3.5; IC025 3.3). The disproportionality analysis for mAbs sub-class showed a significant ROR (13.3; ROR025 11.4) and IC (3.6; IC025 3.4). Also, the disproportionality analysis for gepants sub-class revealed a significant ROR (n = 8; 4.9; ROR025 2.5) and IC (2.0; IC025 0.8). Each single anti-CGRP had a significant ROR and IC. Conclusion: The disproportionality analysis showed a significant risk of reporting for RP associated with anti-CGRP. Notably, RP is described in patient with migraine. The exact mechanism of how RP and migraine are related is not fully understood, but it may involve CGRP. CGRP could have a protective role in maintaining peripheral blood flow. In this way, some authors suggest that anti-CGRP could activate or exacerbate RP. Further investigations, including observational studies and clinical assessments, are warranted to clarify the role of these drugs.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
