Evidence map›Paper›PMID 26733110›Full record

Trial reportAnnals of the rheumatic diseases2016

Comparison of adding tocilizumab to methotrexate with switching to tocilizumab in patients with rheumatoid arthritis with inadequate response to methotrexate: 52-week results from a prospective, randomised, controlled study (SURPRISE study).

Yuko Kaneko, Tatsuya Atsumi, Yoshiya Tanaka, Masayuki Inoo, Hitomi Kobayashi-Haraoka, Koichi Amano, Masayuki Miyata, Yohko Murakawa, Hidekata Yasuoka, Shintaro Hirata and 6 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01120366 (Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation), which is not on this map. Cited by 44 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 5 pooled it
15.6field-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.

NCT01120366 phase4completednot on this map

Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation

TypeinterventionalSponsorSURPRISE Study GroupRan2009 to 2014Enrolled233ConditionsRheumatoid ArthritisArmsTocilizumab plus methotrexate, Tocilizumab
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 5 syntheses or guidelines pooled it, 112 citations in OpenAlex.

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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

16 authors at 11 institutions in 1 country.

Yuko KanekoDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Tatsuya AtsumiDivision of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Masayuki InooDepartment of Internal Medicine, Utazu Hospital, Ayauta-gun, Kagawa, Japan.
Hitomi Kobayashi-HaraokaDivision of Hematology and Rheumatology, Nihon University School of Medicine, Tokyo, Japan.
Koichi AmanoDepartment of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.
Masayuki MiyataDepartment of Internal Medicine, Fukushima Red-Cross Hospital, Fukushima, Japan.
Yohko MurakawaDepartment of Rheumatology, Shimane University Faculty of Medicine, Shimane, Japan.
Hidekata YasuokaDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Shintaro HirataThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Hayato NagasawaDepartment of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.
Eiichi TanakaInstitute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.
Nobuyuki MiyasakaGraduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.
Hisashi YamanakaInstitute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.
Kazuhiko YamamotoDepartment of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Tsutomu TakeuchiDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Keio University · JPTokyo Women's Medical University · JPUniversity of Occupational and Environmental Health Japan · JPHokkaido University · JPNihon University · JPSaitama Medical University · JPShimane University · JPSocial Insurance Saitama Chuo Hospital · JPThe University of Tokyo · JPTokushima Red Cross Hospital · JPTokyo Medical and Dental University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare the efficacy and safety between tocilizumab added to methotrexate and tocilizumab switched from methotrexate in patients with active rheumatoid arthritis (RA).

methodsThis is a 2-year randomised, controlled study. RA patients with moderate or high disease activity despite methotrexate were randomly assigned either to tocilizumab added to methotrexate (add-on) or tocilizumab switched from methotrexate (switch). The primary endpoint was the DAS28 remission rate at week 24. Secondary objectives included other clinical efficacy indices, radiological outcomes assessed with the van der Heijde-modified total Sharp scoring system (mTSS), and safety.

resultsOf 223 randomised patients, 83% completed 52 weeks. DAS28 remission rates at week 24 were 70% for add-on and 55% for switch (p=0.02), but they became comparable at week 52 (72% vs 70%, p=0.86). Structural remission rates (mTSS≤0.5) at week 52 were not different (66% vs 64%, p=0.92). However, clinically relevant radiographic progression rates (CRRP; mTSS≥3) tended to be higher with the switch than with the add-on (15% vs 7%, p=0.07). Radiographic progression in the CRRP patients was larger with the switch than with the add-on (9.0/year vs 5.0/year, p=0.04). The difference in the mean C-reactive protein of the CRRP patients was significant for the first 24 weeks (1.56 vs 0.49, p=0.001) but not for the following 28 weeks (0.10 vs 0.04, p=0.1). Overall safety was preferable in the switch group.

conclusionsIn RA patients with inadequate response to methotrexate, tocilizumab added to methotrexate more rapidly suppressed inflammation than tocilizumab switched from methotrexate, leading to superior clinical efficacy and prevention of joint destruction. TRIAL REGISTRATION NUMBER: NCT01120366.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidC-Reactive ProteinDisease ProgressionDrug SubstitutionDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedProspective StudiesRadiographySeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsC-Reactive ProteinMethotrexatetocilizumabDisease ActivityDMARDs (biologic)Rheumatoid ArthritisTreatment

Identifiers

PMID26733110
PMCPMC5099201
OpenAlexW2230391954

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.