Network meta-analysis of reported adverse events in randomized trials comparing CGRPs for the prophylaxis of episodic migraine

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Scoping review (including literature review)
• Data collection methods:
  Secondary use of data

Non-interventional study

No information provided.

Study drug and medical condition

• Medicinal product name:
  AIMOVIG

  EMGALITY

  AJOVY

  VYEPTI

  VYDURA

  AQUIPTA
• Medicinal product name, other:
  Rimegepant (Nurtec ODT®/Vydura®); Atogepant (Qulipta®/Aquipta ®)
• Study drug International non-proprietary name (INN) or common name:
  ERENUMAB

  GALCANEZUMAB

  FREMANEZUMAB

  EPTINEZUMAB

  RIMEGEPANT

  ATOGEPANT
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CD01) erenumab

  erenumab

  (N02CD02) galcanezumab

  galcanezumab

  (N02CD03) fremanezumab

  fremanezumab

  (N02CD05) eptinezumab

  eptinezumab

  (N02CD06) rimegepant

  rimegepant

  (N02CD07) atogepant

  atogepant

Population studied

• Short description of the study population:
  The population for this study are adult patients (18 years) with EM enrolled in randomized controlled trials evaluating CGRP-targeted therapies for migraine prophylaxis.

Study design details

• Study design:
  The study is a network meta-analysis (NMA) of randomized controlled trials.
• Main study objective:
  Primary Objectives ; 1. To compare the relative rates of adverse events from RCTs of the primary outcomes: nausea, constipation & gastrointestinal discomfort/disturbances (as grouped outcome), fatigue & somnolence (as grouped outcome), and hypersensitivity reactions (as grouped outcome) between CGRP-targeted therapies for prophylaxis in EM.; 2. To compare the relative rates of adverse events from RCTs of the secondary outcomes: nasopharyngitis, dyspnea, injection site-related AEs (as grouped outcome), and discontinuation (all-cause and due to AEs).; ; Secondary Objectives; To estimate the incidence (proportion) of various AEs and treatment discontinuation (all cause and due to AEs) from RCTs.
• Comparators:
  • Placebo; • Any treatment included in list of interventions
• Outcomes:
  Safety and tolerability outcomes, including (but not limited to):; • Nausea, ; • Constipation, ; • Gastrointestinal discomfort/disturbances, ; • Fatigue, ; • Somnolence,; • Hypersensitivity reactions; Hypersensitivity reaction; Anaphylaxis; Angioedema; Hypersensitivity event – rash; Severe rash; Urticaria; Swelling; Oedema; • Nasopharyngitis; • Dyspnea; • Injection site-related AEs; Injection site pain; Injection site erythema; Injection site pruritus; Injection site reaction; Injection site induration; • Discontinuation (all cause), Discontinuation due to AEs