Evidence map›Paper›PMID 40803820›Full record

Trial reportRMD open2025

Immunogenicity of adjuvanted recombinant zoster vaccine in patients with rheumatoid arthritis treated with upadacitinib: 60-week results from a randomised controlled trial substudy.

Kevin L Winthrop, Justin Klaff, Sara K Penn, Yanxi Liu, Conrado García, Eduardo Mysler, Alvin F Wells, Xianwei Bu, Irina Fish, Michael Chen and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02629159 (A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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.

NCT02629159 phase3active not recruitingnot on this map

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

TypeinterventionalSponsorAbbVieRan2015 to 2027Enrolled1,629ConditionsRheumatoid ArthritisArmsPlacebo for Adalimumab, Adalimumab, Placebo for Upadacitinib, Upadacitinib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  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

11 authors.

Kevin L WinthropSchools of Medicine and Public Health, Oregon Health & Science University School of Medicine, Portland, Oregon, USA winthrop@ohsu.edu.ORCID 0000-0002-3892-6947
Justin KlaffAbbVie Inc, North Chicago, Illinois, USA.
Sara K PennAbbVie Inc, North Chicago, Illinois, USA.
Yanxi LiuAbbVie Inc, North Chicago, Illinois, USA.
Conrado GarcíaRheumatology Unit, Hospital General de México Dr Eduardo Liceaga, Mexico City, Mexico.
Eduardo MyslerDepartment of Rheumatology, Organización Médica de Investigación SA, Buenos Aires, Argentina.
Alvin F WellsDepartment of Rheumatology, American Medical Group, Destin, Florida, USA.
Xianwei BuAbbVie Inc, North Chicago, Illinois, USA.
Irina FishAbbVie Inc, North Chicago, Illinois, USA.
Michael ChenAbbVie Inc, North Chicago, Illinois, USA.
Anthony L CunninghamCentre for Virus Research, The Westmead Institute for Medical Research, Sydney ID, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the immunogenicity of adjuvanted recombinant zoster vaccine (RZV) in patients with rheumatoid arthritis receiving upadacitinib 15 mg once daily (QD) with background methotrexate.

methodsEligible patients in SELECT-COMPARE (NCT02629159) receiving upadacitinib 15 mg QD and background methotrexate received RZV at weeks 0 and 12. Antibody titres were collected at weeks 0, 4, 16 and 60 (prevaccination, 4 weeks after first dose, and 4 and 48 weeks after second dose). The primary endpoint was the proportion of patients achieving a satisfactory humoral response to RZV at week 16 (≥ 4-fold increase in prevaccination anti-glycoprotein E (gE) antibody titres). Cell-mediated immune (CMI) response to RZV (≥ 2-fold increase in prevaccination gE-specific CD4+ [2+] T-cell frequency) was assessed at each time point in a subcohort of 38 patients. Safety was assessed for 30 days after each vaccination.

resultsOverall, 93 patients received both RZV doses (78.5% female; mean age, 62.4 years). At baseline, 49.5% used concomitant corticosteroids (median daily dose, 5.0 mg). Satisfactory humoral responses to RZV were observed in 87.8% (95% CI 81.0 to 94.5) of patients at week 16. Age and concomitant corticosteroid use did not affect RZV antibody response. Over 60% of patients achieved a CMI response to RZV at all time points. No serious adverse events were reported. One patient developed herpes zoster 4 months after the second RZV dose.

conclusionsMost patients receiving upadacitinib 15 mg QD with background methotrexate achieved satisfactory humoral and CMI responses 4 weeks after the second RZV vaccination (week 16).

Indexed as

Arthritis, RheumatoidHerpes ZosterHerpes Zoster VaccineHeterocyclic Compounds, 3-RingImmunogenicity, VaccineAdultAgedAntibodies, ViralAntirheumatic AgentsFemaleHerpesvirus 3, HumanHumansMaleMethotrexateMiddle AgedTreatment OutcomeAntibodies, ViralAntirheumatic AgentsHerpes Zoster VaccineHeterocyclic Compounds, 3-RingMethotrexateupadacitinibVaccines, SyntheticAntirheumatic AgentsArthritis, RheumatoidVaccination

Identifiers

PMID40803820
PMCPMC12352179

What OpenQuestion holds

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Registered trials

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.