Evidence map›Paper›PMID 36725768›Full record

ArticleRheumatology and therapy2023

Clinical Efficacy of Sarilumab Versus Upadacitinib Over 12 weeks: An Indirect Treatment Comparison.

Thomas Huizinga, Ernest Choy, Amy Praestgaard, Hubert van Hoogstraten, Patrick R LaFontaine, Patricia Guyot, Daniel Aletaha, Ulf Müller-Ladner, Yoshiya Tanaka, Jeffrey R Curtis and 1 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% 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.

NCT01709578 phase3completednot on this map

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-α Antagonists

TypeinterventionalSponsorSanofiRan2012 to 2015Enrolled546ConditionsRheumatoid ArthritisArmsSarilumab, placebo, hydroxychloroquine, methotrexate, sulfasalazine
NCT02706847 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

TypeinterventionalSponsorAbbVieRan2016 to 2022Enrolled499ConditionsRheumatoid ArthritisArmsPlacebo, Upadacitinib
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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 at 9 institutions in 7 countries.

Thomas HuizingaLeiden University Medical Centre, Leiden, The Netherlands. t.w.j.huizinga@lumc.nl.ORCID http://orcid.org/0000-0001-7033-7520
Ernest ChoyCREATE Centre, Cardiff University, Cardiff, UK.
Amy PraestgaardSanofi, Cambridge, MA, USA.
Hubert van HoogstratenSanofi, Bridgewater, NJ, USA.
Patrick R LaFontaineSanofi, Cambridge, MA, USA.
Patricia GuyotSanofi, Chilly-Mazarin, France.
Daniel AletahaMedical University Vienna, Vienna, Austria.
Ulf Müller-LadnerDepartment of Rheumatology and Clinical Immunology, Justus-Liebig University, Campus Kerckhoff, Bad Nauheim, Germany.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Jeffrey R CurtisDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.
Roy FleischmannMetroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, USA.
Sanofi (United States) · USCardiff University · GBKerckhoff Klinik · DELeiden University Medical Center · NLMedical University of Vienna · ATMetroplex Clinical Research Center · USSanofi (France) · FRUniversity of Alabama at Birmingham · USUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe efficacy of sarilumab and upadacitinib, in combination with disease-modifying antirheumatic drugs (DMARDs), was demonstrated in phase 3 clinical trials of patients with rheumatoid arthritis (RA) refractive to previous biologic DMARDs. In the absence of head-to-head clinical trials, the matching-adjusted indirect comparison (MAIC) and simulated treatment comparison (STC) estimate the relative efficacy of sarilumab and upadacitinib in patients with RA who had an inadequate response to previous biologic DMARDs.

methodsPatient-level data for sarilumab were obtained from the TARGET trial (NCT01709578) and published aggregate data for upadacitinib were obtained from the SELECT-BEYOND trial (NCT02706847). For the MAIC, individual patient data from the TARGET trial were assigned weights such that weighted mean baseline characteristics of the treatment effect modifiers matched those from SELECT-BEYOND. For the STC, the TARGET patient-level data and mean baseline values from SELECT-BEYOND were used to simulate sarilumab treatment effects for a SELECT-BEYOND population. Endpoints evaluated included the American College of Rheumatology (ACR) response criteria ACR20/50/70, Disease Activity Score-28 for Rheumatoid Arthritis with C-reactive protein (DAS28-CRP) < 3.2, DAS28-CRP < 2.6, Simple Disease Activity Index (SDAI) < 3.3, and Clinical Disease Activity Index (CDAI) < 2.8 at 12 weeks.

resultsThe analysis included 365 patients from TARGET and aggregated data of 333 patients from SELECT-BEYOND. Matching for potential treatment effect baseline modifiers (i.e., age, oral glucocorticoid use, tender joint count of 68 counts, swollen joint count of 66 counts, serum CRP level, and patient global assessment of disease activity) resulted in a reduction of the effective sample size of TARGET population to 166. Following MAIC and STC analysis, the odds of achieving all aforementioned clinical outcomes versus placebo at week 12 were similar for sarilumab and upadacitinib.

conclusionIn the MAIC and STC analyses from TARGET and SELECT-BEYOND trials, the efficacy of sarilumab and upadacitinib were comparable.

Indexed as

Matching-adjusted indirect comparisonRheumatoid arthritisSarilumabSimulated treatment comparisonUpadacitinib

Identifiers

PMID36725768
PMCPMC10140231
OpenAlexW4318763260

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.