Evidence map›Paper›PMID 38182801›Full record

ArticleClinical rheumatology2024

Effectiveness and safety of sarilumab in patients with rheumatoid arthritis: A multicenter, retrospective, inverse probability of treatment-weighted analysis based on the FRAB-registry.

Hiroshi Harada, Masakazu Kondo, Akira Maeyama, Takaaki Fukuda, Satoshi Ikemura, Eisuke Shono, Tomomi Tsuru, Yasushi Inoue, Seiji Yoshizawa, Hiroaki Niiro and 1 more

Erratum issuedAbstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical rheumatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 28% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 1 country.

Hiroshi HaradaDepartment of Orthopaedic Surgery, Rheumatology Center, Yagi Hospital, 2-21-25 Maidashi, Higashi-Ku, Fukuoka, 812-0054, Japan. Ztd02411@nifty.com.ORCID http://orcid.org/0009-0005-0149-9434
Masakazu KondoKondo Clinic of Rheumatology and Orthopaedic Surgery, 3-10-11 Tenjin, Chuo-Ku, Fukuoka, 810-0001, Japan.
Akira MaeyamaDepartment of Orthopaedic Surgery, Fukuoka University, 7-45-1 Nanakuma, Jonan-Ku, Fukuoka, 814-0180, Japan.
Takaaki FukudaDepartment of Rheumatology, Rheumatology Center, Koga Hospital 21, 3-3-8 Miyanojin, Kurume City, 839-0801, Japan.
Satoshi IkemuraDepartment of Orthopaedic Surgery, Fukuoka Red Cross Hospital, 3-1-1 Ogusu, Minami-Ku, Fukuoka, 815-8555, Japan.
Eisuke ShonoShono Rheumatology Clinic, Nishijin Prime Building, 1-10-27 Nishijin, Sawara-Ku, Fukuoka, 814-0002, Japan.
Tomomi TsuruPS Clinic, Random Square, 6-18 Tenya-Machi, Hakata-Ku, Fukuoka, 812-0025, Japan.
Yasushi InoueDepartment of Rheumatology, Fukuoka Red Cross Hospital, 3-1-1 Ogusu, Minami-Ku, Fukuoka, 815-8555, Japan.
Seiji YoshizawaDepartment of Rheumatology, Hamanomachi Hospital, 3-3-1 Nagahama, Chuo-Ku, Fukuoka, 810-8539, Japan.
Hiroaki NiiroDepartment of Medicine and Biosystemic Science, Kyushu University, 3-1-1 Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan.
Yasuharu NakashimaDepartment of Orthopaedic Surgery, Kyushu University, 3-1-1 Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan.
Japanese Red Cross Fukuoka Hospital · JPKyushu University · JPFukuoka University · JPHamanomachi Hospital · JPKoga Hospital · JPNishida Hospital · JPNishijin Hospital · JPOno Clinic · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe efficacy and safety of sarilumab (SARI) were investigated in real-world clinical practice in Japan.

methodSubjects were 121 rheumatoid arthritis (RA) patients in 23 medical institutions in Fukuoka Prefecture, Japan, who started treatment with SARI between May 2018 and November 2021. Data on the SARI starting dose, patients' baseline characteristics, disease activity, and blood test data at the start of treatment, as well as follow-up data on the SARI dose, disease activity, and adverse events until Week 52. Safety and the continuation rate calculated by the Kaplan-Meier method were evaluated, and the effectiveness of treatment at 1 year was assessed using the clinical disease activity index (CDAI). Patients' baseline characteristics for which significant differences were evident were adjusted with a propensity score by using the inverse probability of treatment-weighting (IPTW) method.

resultsThe continuation rate at Week 52 was 66.1%. The CDAI showed significant improvement from Week 4 that was maintained until Week 52. Comparisons conducted after IPTW adjustment for patients' baseline characteristics for which significant differences were evident revealed no significant differences at Week 52 between the groups classified by higher or lower body mass index (BMI) (p = 0.231), serious comorbidities (p = 0.973), MTX use (p = 0.321), or prior treatment with ≤ 1 or ≥ 2 biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) (p = 0.765).

conclusionsThe results showed that the efficacy of SARI is not affected by BMI, comorbidities, MTX use, or the number of prior b/tsDMARDs, and no new safety concerns were apparent. Key Points • This is the first real-world clinical study to report on the efficacy and safety of SARI in Japan. The results of this study indicate that the efficacy of SARI was not affected by BMI, comorbidities, MTX use, or number of previous b/tsDMARDs. • It was shown that SARI can be used in a Japanese population without any new side effects.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidHumansMethotrexatePropensity ScoreRegistriesRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexatesarilumabInverse probability of treatment-weightingReal-worldRheumatoid arthritisSarilumab

Identifiers

PMID38182801
OpenAlexW4390630005

What OpenQuestion holds

Textmetadata
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.