Evidence map›Paper›PMID 29853455›Full record

Trial reportAnnals of the rheumatic diseases2018

Tocilizumab discontinuation after attaining remission in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate: results from a prospective randomised controlled study (the second year of the SURPRISE study).

Yuko Kaneko, Masaru Kato, Yoshiya Tanaka, Masayuki Inoo, Hitomi Kobayashi-Haraoka, Koichi Amano, Masayuki Miyata, Yohko Murakawa, Hidekara Yasuoka, Shintaro Hirata and 6 more

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

Trial report in Annals of the rheumatic diseases, 2018. 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 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
6.7field-weighted citation impact, top 3% 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

20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
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  13. Translating IL-6 biology into effective treatments.Nature reviews. Rheumatology · 2020
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  18. Observational
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  20. New insights and long-term safety of tocilizumab in rheumatoid arthritis.Therapeutic advances in musculoskeletal disease · 2018
    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

16 authors at 11 institutions in 1 country.

Yuko KanekoDepartment of Internal Medicine, Division of Rheumatology, School of Medicine, Keio University, Tokyo, Japan.
Masaru KatoDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Masayuki InooInternal Medicine, Utazu Hospital, Ehime, 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, Izumo, Japan.
Hidekara YasuokaDepartment of Internal Medicine, Division of Rheumatology, School of Medicine, Keio University, Tokyo, Japan.
Shintaro HirataThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.ORCID 0000-0002-2474-9943
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, University of Tokyo, Tokyo, Japan.
Tsutomu TakeuchiDepartment of Internal Medicine, Division of Rheumatology, School of Medicine, Keio University, Tokyo, Japan.
SURPRISE study group
Keio University · JPTokyo Women's Medical University · JPUniversity of Occupational and Environmental Health Japan · JPHokkaido University · JPNihon University · JPShimane University · JPShizuoka City Shimizu Hospital · 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 evaluate the sustained remission and low disease activity after discontinuation of tocilizumab in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate.

methodsThe SURPRISE study was a 2-year, open-label randomised controlled study. Among patients who had been randomised to additional tocilizumab (ADD-ON) or switch to tocilizumab (SWITCH) in the first year, those who achieved remission based on the disease activity score for 28 joints (DAS28-ESR<2.6) discontinued tocilizumab at week 52 and were observed for the following 52 weeks. The endpoint of the second year included tocilizumab-free remission and low disease-activity rates, functional outcome, radiological outcomes assessed with the modified total Sharp score (mTSS) and safety. The efficacy of reinstituted tocilizumab/methotrexate was also evaluated.

resultsA total of 105 patients who achieved remission at week 52 discontinued tocilizumab; 51 in ADD-ON continued methotrexate and 54 in SWITCH received no disease-modifying antirheumatic drugs. Sustained DAS28 low disease-activity rates were significantly higher in ADD-ON than in SWITCH (55%vs27%, p=0.005). Sustained remission rates at week 104 were 24% for ADD-ON and 14% for SWITCH (p=0.29). Radiological progression was comparable between both groups (mTSS; 0.37vs0.64, p=0.36). The restart of tocilizumab induced remission in all except two patients after 36 weeks, irrespective of concomitant methotrexate.

conclusionSustained low disease activity after tocilizumab discontinuation could be maintained with continued methotrexate in more than half of the patients. Retreatment with tocilizumab led to remission in more than 90% of patients. TRIAL REGISTRATION NUMBER: NCT01120366; Results.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDrug SubstitutionDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedProspective StudiesRemission InductionSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexatetocilizumabdmards (biologic)methotrexaterheumatoid arthritis

Identifiers

PMID29853455
PMCPMC6104678
OpenAlexW2805119855

What OpenQuestion holds

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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.