Evidence map›Paper›PMID 34508594›Full record

ArticleRheumatology (Oxford, England)2022

Sarilumab monotherapy vs sarilumab and methotrexate combination therapy in patients with rheumatoid arthritis.

Gerd R Burmester, Vivian P Bykerk, Maya H Buch, Yoshiya Tanaka, Hideto Kameda, Amy Praestgaard, Hubert van Hoogstraten, Antonio Fernandez-Nebro, Thomas Huizinga

Open access · hybridAbstract read
In one paragraph

Article in Rheumatology (Oxford, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 23% 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

8 citing papers in PubMed, 8 citations in OpenAlex.

  1. Observational
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
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

9 authors at 8 institutions in 6 countries.

Gerd R BurmesterDepartment of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany.ORCID 0000-0001-7518-1131
Vivian P BykerkDepartment of Rheumatology, Inflammatory Arthritis Center, Hospital for Special Surgery, New York, NY, USA.
Maya H BuchDivision of Musculoskeletal & Dermatological Sciences, Centre for Musculoskeletal Research, Faculty of Biology, Medicine & Health, University of Manchester.ORCID 0000-0002-8962-5642
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.ORCID 0000-0002-0807-7139
Hideto KamedaDivision of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.
Amy PraestgaardDepartment of Biostatistics, Sanofi, Cambridge, MA.
Hubert van HoogstratenDepartment of, Global Medical Affairs, Sanofi, Bridgewater, NJ, USA.
Antonio Fernandez-NebroDepartment of Rheumatology, UGC Rheumatology, Institute of Biomedical Research in Malaga (IBIMA), Regional University Hospital of Malaga, University of Málaga, Málaga, Spain.
Thomas HuizingaDepartment of Rheumatology, Leiden University, Leiden, the Netherlands.
Sanofi (United States) · USCharité - Universitätsmedizin Berlin · DEHospital for Special Surgery · USInstituto de Investigación Biomédica de Málaga · ESLeiden University · NLToho University · JPUniversity of Manchester · GBUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveSarilumab, as monotherapy or in combination with conventional synthetic DMARDs, such as MTX, has demonstrated improvement in clinical outcomes in patients with RA. The primary objective of this post hoc analysis was to compare the efficacy of sarilumab (200 mg every 2 weeks) monotherapy (MONARCH study) with that of sarilumab and MTX combination therapy (MOBILITY study) at week 24.

methodsThe endpoints assessed were mean change from baseline in the Clinical Disease Activity Index (CDAI), 28-joint Disease Activity using CRP (DAS28-CRP), CRP, haemoglobin (Hb), pain visual analogue scale (VAS) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue. Least square (LS) mean change from baseline (95% CI) at week 24 for all endpoints was compared between the treatment arms for adjusted comparisons.

resultsThis analysis included 184 patients on sarilumab monotherapy and 399 patients on sarilumab plus MTX. Differences (P < 0.05) were observed in ethnicity, region, body mass index group, rheumatoid factor, anti-cyclic citrullinated peptide antibodies, swollen joint count, CRP, CDAI and oral glucocorticoid use between these treatment groups. After adjusting for these differences in a mixed-effect model repeated measure, LS mean change from baseline for all assessments was similar between the treatment groups with overlapping CIs: CDAI, -28.79 vs -26.21; DAS28-CRP, -2.95 vs -2.81; CRP, -18.31 vs -16.46; Hb, 6.59 vs 8.09; Pain VAS, -33.62 vs -31.66; FACIT-Fatigue, 9.90 vs 10.24.

conclusionThis analysis demonstrated that the efficacy of sarilumab monotherapy was similar to that of sarilumab and MTX combination therapy.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAntibodies, Monoclonal, HumanizedDrug Therapy, CombinationFatigueHumansMethotrexatePainTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexatesarilumabcombination with MTXIL-6RiMOBILITYMONARCHmonotherapyrheumatoid arthritissarilumab

Identifiers

PMID34508594
PMCPMC9157062
OpenAlexW3197430089

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.