Evidence map›Paper›PMID 33179263›Full record

Trial reportHeadache2020

Treatment Outcomes in Patients Treated With Galcanezumab vs Placebo: Post Hoc Analyses From a Phase 3 Randomized Study in Patients With Episodic Cluster Headache.

David Kudrow, J Scott Andrews, Mallikarjuna Rettiganti, Tina Oakes, Jennifer Bardos, Charly Gaul, Robert Riesenberg, Richard Wenzel, Dulanji Kuruppu, James Martinez

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

Trial report in Headache, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Observational
  2. Review
  3. Review
  4. 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

10 authors at 4 institutions in 2 countries.

David KudrowCalifornia Medical Clinic for Headache, Santa Monica, CA, USA.
J Scott AndrewsEli Lilly and Company, Indianapolis, IN, USA.
Mallikarjuna RettigantiEli Lilly and Company, Indianapolis, IN, USA.
Tina OakesEli Lilly and Company, Indianapolis, IN, USA.
Jennifer BardosEli Lilly and Company, Indianapolis, IN, USA.
Charly GaulMigraine and Headache Clinic, Koenigstein, Germany.ORCID https://orcid.org/0000-0002-9362-3711
Robert RiesenbergAtlanta Center for Medical Research, Atlanta, GA, USA.
Richard WenzelEli Lilly and Company, Indianapolis, IN, USA.
Dulanji KuruppuEli Lilly and Company, Indianapolis, IN, USA.
James MartinezEli Lilly and Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USAtlanta Medical Center · USCalifornia Medical Clinic for Headache · USMigräne Klinik Königstein · DE

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

backgroundCluster headache (CH) is a highly disabling primary headache disorder. To date, characterization of outcomes in the preventive treatment of episodic CH, including precise definitions of clinically meaningful attack frequency reduction and impact on acute treatment management, is lacking.

methodsThis was a Phase 3, randomized, double-blind, placebo-controlled study in patients (men or women aged 18-65 years) diagnosed with episodic CH as defined by the International Classification of Headache Disorders-3 beta criteria. In this post hoc analysis, we evaluated the median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attack frequency, and impact on acute medication use. An anchor-based assessment of clinically relevant attack frequency reduction using the Patient Global Impression of Improvement (PGI-I) scores at Week 4 was also assessed.

resultsThe median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attacks was consistently shorter (9-10 days sooner) with galcanezumab vs placebo (median [95% confidence interval, 95% CI]: ≥50%, 5 days [4.0 to 7.0] vs 14 days [6.0 to 19.0]; ≥75%, 11 days [7.0 to 16.0] vs 21 days [13.0 to 26.0]; 100%, 22 days [16.0 to 37.0] vs 32 days [23.0 to 34.0]). Mean reduction from baseline in the overall frequency of weekly pooled acute medication use across Weeks 1-3 was significantly greater with galcanezumab vs placebo (11.0 vs 5.5; odds ratio, OR [95% CI]: 5.52 [1.02, 10.01]; P value = .017). Patients reporting "much better" on the PGI-I experienced a median weekly CH attack reduction of approximately 43% from baseline across Weeks 1-3. The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]).

conclusionsFaster median time-to-first occurrence of response rates, lower frequency of pooled acute medications use, and a greater proportion of patients achieving a response anchored by patient-reported improvement were observed for galcanezumab vs placebo.

Indexed as

Outcome Assessment, Health CareAdultAntibodies, Monoclonal, HumanizedCluster HeadacheDouble-Blind MethodFemaleHumansMaleMiddle AgedTime FactorsAntibodies, Monoclonal, Humanizedgalcanezumabacute medication use frequencyepisodic cluster headachepatient-reported outcomesresponder rateresponder thresholdtime-to-first occurrence

Identifiers

PMID33179263
PMCPMC7756634
OpenAlexW3099654104

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.