Evidence map›Paper›PMID 25832859›Full record

Trial reportArthritis care & research2015

Sustainable Efficacy of Switching From Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis.

Atsushi Ogata, Tatsuya Atsumi, Takaaki Fukuda, Yasuhiko Hirabayashi, Masaaki Inaba, Naoki Ishiguro, Motokazu Kai, Daisuke Kawabata, Daihei Kida, Hitoshi Kohsaka and 13 more

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis care & research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
4.0field-weighted citation impact, top 6% 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Towards Personalized Medicine in Rheumatoid Arthritis.Open access rheumatology : research and reviews · 2024
    Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Observational
  13. Article
  14. Observational
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

23 authors at 18 institutions in 1 country.

Atsushi OgataOsaka University, Osaka, Japan.
Tatsuya AtsumiHokkaido University, Hokkaido, Japan.
Takaaki FukudaKurume University School of Medicine, Fukuoka, Japan.
Yasuhiko HirabayashiHikarigaoka Spellman Hospital, Miyagi, Japan.
Masaaki InabaOsaka City University, Osaka, Japan.
Naoki IshiguroNagoya University, Aichi, Japan.
Motokazu KaiNational Hospital Organization Mie Chuo Medical Center, Mie, Japan.
Daisuke KawabataKyoto University, Kyoto, Japan.
Daihei KidaNagoya Medical Centre, Aichi, Japan.
Hitoshi KohsakaTokyo Medical and Dental University, Tokyo, Japan.
Ryutaro MatsumuraNational Hospital Organization, Chiba-East National Hospital, Chiba, Japan.
Seiji MinotaJichi Medical University, Tochigi, Japan.
Masaya MukaiSapporo City General Hospital, Hokkaido, Japan.
Takayuki SumidaUniversity of Tsukuba, Ibaraki, Japan.
Kiyoshi TakasugiDogo Spa Hospital, Ehime, Japan.
Shigenori TamakiNagoya Rheumatology Clinic, Nagoya, Japan.
Tsutomu TakeuchiKeio University, Tokyo, Japan.
Atsuhisa UedaYokohama City University, Kanagawa, Japan.
Kazuhiko YamamotoUniversity of Tokyo, Tokyo, Japan.
Hisashi YamanakaTokyo Women's Medical University, Tokyo, Japan.
Hajime YoshifujiKyoto University, Kyoto, Japan.
Akira NomuraChugai Pharmaceutical, Tokyo, Japan.
Musashi Study Investigators
Kyoto University · JPNagoya Medical Center · JPChiba East Hospital · JPDogo Onsen Hospital · JPHokkaido University · JPJichi Medical University · JPKeio University · JPKurume University · JPMie Chuo Medical Center · JPNagoya University · JPOsaka City University · JPOsaka University · JPSapporo City General Hospital · JPThe University of Tokyo · JPTokyo Medical and Dental University · JPTokyo Women's Medical University · JPUniversity of Tsukuba · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients.

methodsPatients who had completed 24 weeks of TCZ-SC (162 mg/2 weeks) or TCZ-IV (8 mg/kg/4 weeks) monotherapy in the double-blind period of the MUSASHI study were enrolled in an 84-week open-label extension period. All received TCZ-SC (162 mg/2 weeks) monotherapy. Effects of the IV to SC switch were evaluated at week 36 (12 weeks after switching).

resultsOverall, 319 patients received ≥1 dose of TCZ-SC during the open-label extension period; 160 switched from TCZ-IV to TCZ-SC (TCZ IV/SC) and 159 continued TCZ-SC (TCZ SC/SC). Disease Activity Score in 28 joints using the erythrocyte sedimentation rate clinical remission rates were 62.5% (100 of 160) for TCZ IV/SC and 50.0% (79 of 158) for TCZ SC/SC at week 24, and were maintained at 62.5% (100 of 160) and 57.0% (90 of 158), respectively, at week 36. In the TCZ IV/SC group, 9% of patients (9 of 100) who had achieved remission at week 24 could not maintain remission at week 36. In TCZ IV/SC patients weighing ≥70 kg, the percentage with a sufficient serum TCZ concentration (≥1 μg/ml) decreased from 90.9% (10 of 11) at week 24 to 45.5% (5 of 11) at week 36. Overall safety profiles were similar in TCZ IV/SC and TCZ SC/SC except for mild injection site reactions in TCZ IV/SC.

conclusionEfficacy is adequately maintained in most patients switching from TCZ-IV (8 mg/kg/4 weeks) to TCZ-SC (162 mg/2 weeks) monotherapy. Patients receiving TCZ-IV can switch to TCZ-SC without serious safety concerns. Clinical efficacy may be reduced after switching in some patients with high body weight.

Indexed as

AdultAntibodies, Monoclonal, HumanizedArthritis, RheumatoidDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansInjections, IntravenousInjections, SubcutaneousJapanMaleMiddle AgedPain MeasurementPatient SatisfactionAntibodies, Monoclonal, Humanizedtocilizumab

Identifiers

PMID25832859
PMCPMC5054840
OpenAlexW2160899423

What OpenQuestion holds

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LicenceCC BY-NC
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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.