Evidence mapPaperPMID 39866124Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2025

Efficacy, Safety, Pharmacokinetics, and Immunogenicity of ABBV-154 in Adults With Glucocorticoid-Dependent Polymyalgia Rheumatica: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial.

Robert F Spiera, Valerie Devauchelle-Pensec, Claire E Owen, Federico Díaz-González, Tsutomu Takeuchi, Edit Drescher, Jaclyn Anderson, Dilek Arikan, Ronilda D'Cunha, Julie Parmentier and 5 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
field-weighted citation impact
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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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

15 authors.

Robert F SpieraHospital for Special Surgery and Weill Medical College of Cornell University, New York, New York.ORCID https://orcid.org/0000-0003-2911-6800
Valerie Devauchelle-PensecINSERM U 1227, Brest University Hospital, Brest, France.ORCID https://orcid.org/0000-0003-0432-825X
Claire E OwenAustin Clinical School, University of Melbourne, Melbourne, Victoria, Australia.
Federico Díaz-GonzálezHospital Universitario de Canarias and Universidad de La Laguna, La Laguna, Spain.ORCID https://orcid.org/0000-0002-4139-9295
Tsutomu TakeuchiKeio University School of Medicine, Shinjuku-ku, Tokyo, and Saitama Medical University, Saitama, Japan.ORCID https://orcid.org/0000-0003-1111-8218
Edit DrescherCsolnoky Ferenc Hospital, Veszprém, Hungary.
Jaclyn AndersonAbbVie Inc., North Chicago, Illinois.
Dilek ArikanAbbVie Inc., North Chicago, Illinois.
Ronilda D'CunhaAbbVie Inc., North Chicago, Illinois.
Julie ParmentierAbbVie Inc., North Chicago, Illinois.
Denise T KruzikasAbbVie Inc., North Chicago, Illinois.
Weihan ZhaoAbbVie Inc., North Chicago, Illinois.
Yang YangAbbVie Inc., North Chicago, Illinois.
Karen StellpflugAbbVie Inc., North Chicago, Illinois.
Frank ButtgereitCharité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.ORCID https://orcid.org/0000-0003-2534-550X

Funding

AbbVie Inc.
6 · The paper itself

Abstract

objectiveAn unmet need exists for glucocorticoid-sparing treatments for patients with polymyalgia rheumatica (PMR). The antibody-drug conjugate ABBV-154 comprises adalimumab conjugated to a glucocorticoid receptor modulator. We evaluated ABBV-154 versus placebo in patients with glucocorticoid-dependent PMR.

methodsIn this phase 2, randomized, double-blind, placebo-controlled, dose-ranging study, eligible patients had confirmed PMR, glucocorticoid response and two or more unequivocal PMR flares while tapering glucocorticoids and still on ≥5 mg daily prednisone equivalent. Randomized patients received subcutaneous placebo or ABBV-154 40, 150, or 340 mg once every other week. The primary efficacy endpoint was time to flare. The sponsor voluntarily terminated the study early.

resultsOverall, 181 patients were randomized (placebo, n = 50; ABBV-154: 40 mg, n = 42; 150 mg, n = 45; 340 mg, n = 44), and 67.4% completed study drug at week 24. Time to flare was longer for patients receiving ABBV-154 than those receiving placebo, with Kaplan-Meier estimate of 24-week flare-free rate being lower for placebo. The hazard ratios of ABBV-154 versus placebo were 0.49 (95% confidence interval [CI], 0.27-0.88), P = 0.017 for 40 mg; 0.44 (95% CI, 0.25-0.79), P = 0.006 for 150 mg; 0.20 (95% CI, 0.09-0.42), P < 0.001 for 340 mg. Incidences of treatment-emergent adverse events were similar between groups, and the most common across ABBV-154 cohorts was COVID-19 (16.0%).

conclusionTreatment effects were observed for ABBV-154 cohorts compared with placebo for time to flare. ABBV-154 was generally well tolerated. Due to early study termination, results should be interpreted with caution.

Indexed as

AdalimumabAntirheumatic AgentsGlucocorticoidsImmunoconjugatesPolymyalgia RheumaticaAgedAged, 80 and overAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsGlucocorticoidsImmunoconjugates

Identifiers

PMID39866124
PMCPMC12311256

What Socratic holds

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LicenceCC BY-NC
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 Socratic graph.