Evidence map›Paper›PMID 30916379›Full record

Trial reportThe British journal of dermatology2019

Adalimumab medium-term dosing strategy in moderate-to-severe hidradenitis suppurativa: integrated results from the phase III randomized placebo-controlled PIONEER trials.

G B E Jemec, M M Okun, S B Forman, W P F Gulliver, E P Prens, U Mrowietz, A W Armstrong, Z Geng, Y Gu, D A Williams and 2 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The British journal of dermatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
6.1field-weighted citation impact, top 3% 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

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. European S2k guidelines for hidradenitis suppurativa/acne inversa part 2: Treatment.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Guideline
  2. Pooled it
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  5. Observational
  6. Article
  7. Review
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  12. Review
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  18. [Hidradenitis suppurativa /acne inversa-surgical options, reconstruction and combinations with drug therapies-an update].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2021
    Review
  19. New perspectives on the treatment of hidradenitis suppurativa.Therapeutic advances in chronic disease · 2021
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 5 countries.

G B E JemecDepartment of Dermatology Zealand University Hospital, Health Sciences Faculty University of Copenhagen, Roskilde, Denmark.ORCID 0000-0002-0712-2540
M M OkunFort HealthCare, Fort Atkinson, WI, U.S.A.
S B FormanForward Clinical Trials, Tampa, FL, U.S.A.
W P F GulliverMemorial University of Newfoundland, St John's, Newfoundland and Labrador, Canada.
E P PrensErasmus University Medical Center, Rotterdam, the Netherlands.
U MrowietzDepartment of Dermatology, Venereology, and Allergology, University Medical Center Schleswig-Holstein, Campus Kiel, Germany.ORCID 0000-0002-9539-0712
A W ArmstrongKeck School of Medicine, University of Southern California, Los Angeles, CA, U.S.A.ORCID 0000-0002-6892-6286
Z GengAbbVie Inc., North Chicago, IL, U.S.A.
Y GuAbbVie Inc., North Chicago, IL, U.S.A.
D A WilliamsAbbVie Inc., North Chicago, IL, U.S.A.
H D TeixeiraAbbVie Inc., North Chicago, IL, U.S.A.
A B KimballHarvard Medical School and Beth Israel Deaconess Hospital, Boston, MA, U.S.A.
AbbVie (United States) · USAtkins (United States) · USErasmus MC · NLHarvard University · USMemorial University of Newfoundland · CAUniversity of Copenhagen · DKUniversity of Southern California · US

Funding

AbbVie Inc.
6 · The paper itself

Abstract

backgroundWeekly adalimumab (Humira

objectivesUsing PIONEER integrated trial results, we aimed to evaluate the optimal medium-term adalimumab maintenance dosing strategy for moderate-to-severe HS.

methodsEach trial had two double-blind periods; 12-week Period A and 24-week Period B. Patients randomized to adalimumab 40 mg every week (ADAew) (Period A), were rerandomized in Period B to ADAew (ADAew/ew), ADA every other week (ADAew/eow), or placebo (ADAew/pbo). Placebo-randomized patients were reassigned in Period B to ADAew (PIONEER I) or placebo (PIONEER II). The primary outcome was HS Clinical Response (HiSCR). Patients who lost response during Period B were discontinued from the study and offered an option to enter the open-label extension (OLE) to receive ADAew. Results are reported across the two study periods, and data were combined from the two study periods and the OLE.

resultsFor week-12 HiSCR achievers, the HiSCR week-36 rate was 48·1% (ADAew/ew) vs. 46·2% (ADAew/eow) and 32·1% (ADAew/pbo). Combining (post hoc) these patients with week-12 partial responders further differentiated outcomes in Period B (ADAew/ew 55·7% vs. ADAew/eow 40·0% and ADAew/pbo 30·1%). Period-B adverse-event rates were ADAew/ew 59·6% vs. ADAew/eow 57·4% and ADAew/pbo 65·0%. One patient (ADAew/ew) reported a serious infection.

conclusionsWeekly adalimumab treatment, effective throughout 36 weeks, was the optimal maintenance medium-term dosing regimen for this population. At least partial response after 12 weeks with continued weekly dosing had better outcomes than dose reduction or interruption. Patients who do not show at least a partial response to weekly adalimumab by week 12 are unlikely to benefit from continued therapy. No new safety risks were identified. What's already known about this topic? Hidradenitis suppurativa (HS) is a chronic inflammatory disease, commonly misinterpreted as an infection and treated with long-term antibiotic regimens or surgical incisions. Based on the chronicity of HS and the lack of evidence for efficacious and safe long-term HS treatments, it is important to evaluate medium- to long-term therapies for HS. Weekly adalimumab (Humira

Indexed as

AdalimumabAdolescentAdultAgedDouble-Blind MethodDrug Administration ScheduleFemaleHidradenitis SuppurativaHumansIntention to Treat AnalysisMaintenance ChemotherapyMaleMiddle AgedPlacebosSeverity of Illness IndexTime FactorsAdalimumabPlacebosTumor Necrosis Factor Inhibitors

Identifiers

PMID30916379
PMCPMC6899827
OpenAlexW2924781650

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.