Evidence map›Paper›PMID 34816388›Full record

ArticleRheumatology and therapy2022

Benefit-Risk Analysis of Upadacitinib Compared with Adalimumab in the Treatment of Patients with Moderate-to-Severe Rheumatoid Arthritis.

Philip Conaghan, Stanley Cohen, Gerd Burmester, Eduardo Mysler, Peter Nash, Yoshiya Tanaka, William Rigby, Jayeshkumar Patel, Tim Shaw, Keith A Betts and 4 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
0.5field-weighted citation impact, top 32% 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, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  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

14 authors at 10 institutions in 5 countries.

Philip ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, National Institute for Health Research, Leeds Biomedical Research Centre-University of Leeds, Leeds, UK.
Stanley CohenMetroplex Clinical Research Center, Dallas, TX, USA.
Gerd BurmesterCharité-Universitätsmedizin Berlin, Berlin, Germany.
Eduardo MyslerOrganización Médica de Investigación, Buenos Aires, Argentina.
Peter NashGriffith University, Brisbane, Queensland, Australia.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.
William RigbyDartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Jayeshkumar PatelAbbVie, Inc, 26525 N Riverwoods Blvd, Mettawa, North Chicago, IL, 60045, USA. jayesh.patel@abbvie.com.
Tim ShawAbbVie Ltd, Maidenhead, UK.
Keith A BettsAnalysis Group, Inc, Los Angeles, CA, USA.
Pankaj PatelAbbVie, Inc, 26525 N Riverwoods Blvd, Mettawa, North Chicago, IL, 60045, USA.
Jianzhong LiuAbbVie, Inc, 26525 N Riverwoods Blvd, Mettawa, North Chicago, IL, 60045, USA.
Rochelle SunAnalysis Group, Inc, Boston, MA, USA.
Roy FleischmannMetroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.
AbbVie (United States) · USAnalysis Group (United States) · USAbbVie (United Kingdom) · GBCharité - Universitätsmedizin Berlin · DEDartmouth–Hitchcock Medical Center · USGriffith University · AUMetroplex Clinical Research Center · USNIHR Leeds Musculoskeletal Biomedical Research Unit · GBThe University of Texas Southwestern Medical Center · USUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRheumatoid arthritis (RA) is a chronic autoimmune disease requiring long-term treatment. Upadacitinib (UPA), a Janus kinase (JAK) inhibitor, is a new treatment for RA. The benefit-risk profile of a medication is best understood by evaluating the number needed to treat (NNT) and the number needed to harm (NNH). This analysis evaluated the comparative risk-benefit of UPA versus adalimumab (ADA).

methodsPost-hoc analyses were performed using data from the SELECT-COMPARE trial of UPA versus placebo (PBO) and UPA versus ADA among patients with active RA who remained on stable methotrexate (MTX) treatment and had an inadequate response; patients who failed to achieve response were rescued by predefined criteria-PBO or ADA switch to UPA, and UPA switch to ADA (all patients on PBO were switched to UPA at week 26). This analysis assessed efficacy and adverse events of special interest (AESIs) at week 26, 48, and 156 (3 years). NNT and NNH (95% confidence intervals) values were calculated between UPA versus ADA for all time points, and between UPA versus PBO for week 26. NNT and NNH values were applied to a hypothetical cohort of 100 patients to estimate the comparative efficacy and safety profiles.

resultsUPA consistently showed greater efficacy than ADA, as evidenced by NNT values < 10 for achievement of Disease Activity Score in 28 joints based on C-reactive protein (DAS28-CRP) of < 2.6 and ≤ 3.2, respectively, and functional improvement. Based on indices for disease assessment other than the DAS28-CRP, remission outcomes were higher with UPA versus ADA over 26 weeks (NNTs: 7-12), 48 weeks (NNTs: 9-16), and 156 weeks (NNTs: 9-15). With the exception of herpes zoster, other AESIs demonstrated a similar risk with UPA versus ADA.

conclusionIn patients with active RA despite MTX use, UPA demonstrated an incremental achievement of clinical outcomes compared to ADA together with a similar profile of AESIs with ADA (with the exception of herpes zoster).

Indexed as

Benefit–risk assessmentEfficacyJanus kinase inhibitorNumber needed to harmNumber needed to treatRheumatoid arthritisSafetyUpadacitinib

Identifiers

PMID34816388
PMCPMC8814262
OpenAlexW3217702884

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.