Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Problematic presentation and use of efficacy measures in current trials of CGRP monoclonal antibodies for episodic migraine prevention: A mini-review

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1)

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Monitoring chronic headache and medication-overuse headache prevalence in Denmark

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Diagnostic delay of cluster headache: A cohort study from the Danish Cluster Headache Survey

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. PACAP27 induces migraine-like attacks in migraine patients

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. The Emperor's New Gepants: Are the Effects of the New Oral CGRP Antagonists Clinically Meaningful?

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Further Questioning of the Significance of the Gepants: A Response

    Research output: Contribution to journalComment/debateResearchpeer-review

  3. Misused and Misleading: "100% Response Rate" to Galcanezumab in Patients With Episodic Migraine

    Research output: Contribution to journalComment/debateResearchpeer-review

  4. Neurologisk undersøgelse i almen praksis: en oversigt baseret på hjemmsiden neurous.dk

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. Neurous.dk: en hjemmeside til brug i uddannelse eller efteruddannelse i neurologisk undersøgelsesteknik

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

BACKGROUND: In trials of monoclonal antibodies against calcitonin gene-related peptide or its receptor for prevention of episodic migraine, we observed two problematic aspects: a) The graphic presentations; b) the methods of calculating "response rates" (≥50% decrease of monthly migraine days from baseline).

OBSERVATIONS: Decrease in monthly migraine days is presented, over time, in figures on a downward (negative) scale from zero at baseline, with the ordinate stopped just beyond the maximum effect of the active drugs. In one trial, decreases in monthly migraine days were -1.8 after placebo, -3.2 after erenumab 70 mg and -3.7 after erenumab 140 mg, with the ordinate stopped at -4.5. The reader can perceive only a relative 2-fold benefit of erenumab versus placebo. If, however, treatment periods are compared with baseline in bar charts, MMDs persisting after treatment in the same trial can be illustrated as follows, creating a different perception: 78% for placebo, 61% for erenumab 70 mg, and 55% for erenumab 140 mg. In the nine trials, "response rates" defined as above were calculated in five different ways, taking different numbers of treatment months into account in comparisons with the one-month baseline. This makes comparisons impossible.

SUGGESTIONS FOR IMPROVEMENTS: Mean monthly migraine days before and after treatment should be presented in a bar chart. Such figures, presenting persisting MMDs, are more clinically relevant and less misleading than decreases from baseline. The definition and methods of calculating and presenting "50% response rates" should be standardized by the Drug Trial Committee of the International Headache Society.

Original languageEnglish
JournalCephalalgia : an international journal of headache
Volume40
Issue number1
Pages (from-to)122-126
Number of pages5
ISSN0333-1024
DOIs
Publication statusPublished - 2020

ID: 58955791