Evidence map›Paper›PMID 35076090›Full record

Trial reportHeadache2022

Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials.

Jessica Ailani, Dulanji K Kuruppu, Mallikarjuna Rettiganti, Tina Oakes, Krista Schroeder, Linda Wietecha, Martha Port, Andrew M Blumenfeld

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Headache, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. The sense of stopping migraine prophylaxis.The journal of headache and pain · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Jessica AilaniDepartment of Neurology, MedStar Georgetown University Hospital, Washington, DC, USA.
Dulanji K KuruppuEli Lilly and Company, Indianapolis, Indiana, USA.
Mallikarjuna RettigantiEli Lilly and Company, Indianapolis, Indiana, USA.
Tina OakesEli Lilly and Company, Indianapolis, Indiana, USA.
Krista SchroederEli Lilly and Company, Indianapolis, Indiana, USA.
Linda WietechaEli Lilly and Company, Indianapolis, Indiana, USA.
Martha PortEli Lilly and Company, Indianapolis, Indiana, USA.ORCID 0000-0001-6559-1014
Andrew M BlumenfeldThe Headache Center of Southern California, The Neurology Center, Carlsbad, California, USA.
Eli Lilly (United States) · USGeorgetown University · USNeurology Center of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe purpose of this study was to propose a definition of "wearing off" at the individual patient-level and determine the percentage of patients with migraine who experience "wearing off" of efficacy of galcanezumab at the end of a treatment cycle using this predefined threshold.

backgroundAnecdotal reports suggest that some patients may experience "wearing off" of efficacy during the last week of their calcitonin gene-related peptide monoclonal antibody treatment cycle. A previous post hoc analysis of galcanezumab demonstrated consistent efficacy at each week throughout all monthly dosing intervals at the population-level, but "wearing off" has not been assessed at the individual patient-level.

methodsPost hoc analyses of clinical trial data from four galcanezumab phase III, randomized, placebo-controlled studies in a total of 2680 patients with high-frequency episodic migraine (EVOLVE-1, EVOLVE-2, and CONQUER studies) or chronic migraine (CM; REGAIN and CONQUER studies) were conducted. "Wearing off" was defined as an increase of greater than or equal to 2 weekly migraine headache days in the last week of the treatment cycle compared to the second week for at least 2 months. The analyses were conducted (1) in all patients and (2) in patients with a clinically meaningful response to treatment.

resultsThe percentage of patients meeting the threshold of "wearing off" was not statistically significantly different among the placebo, galcanezumab 120 mg, and galcanezumab 240 mg treatment groups, both in the total population and in patients with a clinically meaningful response (all ≤9.0%). Although the frequency of "wearing off" in patients with CM and prior preventive failures was numerically greater in the galcanezumab groups (8/89 or 9.0%) compared to placebo (3/95 or 3.2%), these differences were not statistically significant.

conclusionsConsistent with previous analyses at the population-level that showed no evidence of decreased efficacy at the end of a treatment cycle, rates of individual patients meeting the threshold of "wearing off" in this analysis were low and similar among placebo, galcanezumab 120 mg, and galcanezumab 240 mg treatment groups.

Indexed as

Treatment OutcomeAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodFemaleHumansMaleMigraine DisordersAntibodies, Monoclonal, Humanizedgalcanezumabcalcitonin gene-related peptidegalcanezumabmigrainemigraine preventionmonoclonal antibodywear off

Identifiers

PMID35076090
PMCPMC9306502
OpenAlexW4210328041

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.