Evidence map›Paper›PMID 27856432›Full record

Trial reportAnnals of the rheumatic diseases2017

Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial.

Gerd R Burmester, Yong Lin, Rahul Patel, Janet van Adelsberg, Erin K Mangan, Neil M H Graham, Hubert van Hoogstraten, Deborah Bauer, Juan Ignacio Vargas, Eun Bong Lee

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02332590 (A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis), which is not on this map. Cited by 141 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
141citing papers in PubMed, 11 pooled it
29.0field-weighted citation impact, top 1% 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.

NCT02332590 phase3completednot on this map

A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis

TypeinterventionalSponsorSanofiRan2015 to 2020Enrolled369ConditionsRheumatoid ArthritisArmsSarilumab, Adalimumab, Placebo (for sarilumab), Placebo (for adalimumab)
3 · Its place in the literature

Who cites it

141 citing papers in PubMed, 11 syntheses or guidelines pooled it, 311 citations in OpenAlex.

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81 more citing papers are in PubMed but not listed here.

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

10 authors at 5 institutions in 5 countries.

Gerd R BurmesterDepartment of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany.
Yong LinSanofi Genzyme, Bridgewater, New Jersey, USA.
Rahul PatelSanofi Genzyme, Bridgewater, New Jersey, USA.
Janet van AdelsbergRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Erin K ManganRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Neil M H GrahamRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Hubert van HoogstratenSanofi Genzyme, Bridgewater, New Jersey, USA.
Deborah BauerSanofi Genzyme, Bridgewater, New Jersey, USA.
Juan Ignacio VargasQuantum Research, Puerto Varas, Chile.
Eun Bong LeeDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Regeneron (United States) · USSanofi (Belgium) · BESanofi (United States) · USCharité - Universitätsmedizin Berlin · DENew Generation University College · ET

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo compare efficacy and safety of sarilumab monotherapy with adalimumab monotherapy in patients with active rheumatoid arthritis (RA) who should not continue treatment with methotrexate (MTX) due to intolerance or inadequate response.

methodsMONARCH was a randomised, active-controlled, double-blind, double-dummy, phase III superiority trial. Patients received sarilumab (200 mg every 2 weeks (q2w)) or adalimumab (40 mg q2w) monotherapy for 24 weeks. The primary end point was change from baseline in 28-joint disease activity score using erythrocyte sedimentation rate (DAS28-ESR) at week 24.

resultsSarilumab was superior to adalimumab in the primary end point of change from baseline in DAS28-ESR (-3.28 vs -2.20; p<0.0001). Sarilumab-treated patients achieved significantly higher American College of Rheumatology 20/50/70 response rates (sarilumab: 71.7%/45.7%/23.4%; adalimumab: 58.4%/29.7%/11.9%; all p≤0.0074) and had significantly greater improvement in Health Assessment Questionnaire-Disability Index (p=0.0037). Importantly, at week 24, more patients receiving sarilumab compared with adalimumab achieved Clinical Disease Activity Index remission (7.1% vs 2.7%; nominal p=0.0468) and low disease activity (41.8% vs 24.9%; nominal p=0.0005, supplemental analysis). Adverse events occurred in 63.6% (adalimumab) and 64.1% (sarilumab) of patients, the most common being neutropenia and injection site reactions (sarilumab) and headache and worsening RA (adalimumab). Incidences of infections (sarilumab: 28.8%; adalimumab: 27.7%) and serious infections (1.1%, both groups) were similar, despite neutropenia differences.

conclusionsSarilumab monotherapy demonstrated superiority to adalimumab monotherapy by improving the signs and symptoms and physical functions in patients with RA who were unable to continue MTX treatment. The safety profiles of both therapies were consistent with anticipated class effects. TRIAL REGISTRATION NUMBER: NCT02332590.

Indexed as

AdalimumabAdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodFemaleHeadacheHumansInfectionsInjectionsMaleMethotrexateMiddle AgedNeutropeniaAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexatesarilumabDMARDs (biologic)Rheumatoid ArthritisTreatment

Identifiers

PMID27856432
PMCPMC5530335
OpenAlexW2557016092

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.