Evidence map›Paper›PMID 35655317›Full record

Observational studyArthritis research & therapy2022

Rheumatoid arthritis patients initiating rituximab with low number of previous bDMARDs failures may effectively reduce rituximab dose and experience fewer serious adverse events than patients on full dose: a 5-year cohort study.

Antonios Bertsias, Nestor Avgoustidis, Ioannis Papalopoulos, Argyro Repa, Nikolaos Kougkas, Eleni Kalogiannaki, Georgios Bertsias, Irini Flouri, Prodromos Sidiropoulos

Abstract readObservational Study
In one paragraph

Observational study in Arthritis research & therapy, 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
–field-weighted citation impact
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.

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

Antonios Bertsias *Rheumatology, Clinical Immunology and Allergy Department, Medical School University of Crete, 71110 Voutes, Heraklion, Greece.
Nestor Avgoustidis *Rheumatology, Clinical Immunology and Allergy Department, Medical School University of Crete, 71110 Voutes, Heraklion, Greece.
Ioannis PapalopoulosRheumatology, Clinical Immunology and Allergy Department, Medical School University of Crete, 71110 Voutes, Heraklion, Greece.
Argyro RepaRheumatology, Clinical Immunology and Allergy Department, Medical School University of Crete, 71110 Voutes, Heraklion, Greece.
Nikolaos KougkasRheumatology, Clinical Immunology and Allergy Department, Medical School University of Crete, 71110 Voutes, Heraklion, Greece.
Eleni KalogiannakiRheumatology, Clinical Immunology and Allergy Department, Medical School University of Crete, 71110 Voutes, Heraklion, Greece.
Georgios BertsiasRheumatology, Clinical Immunology and Allergy Department, Medical School University of Crete, 71110 Voutes, Heraklion, Greece.
Irini FlouriRheumatology, Clinical Immunology and Allergy Department, Medical School University of Crete, 71110 Voutes, Heraklion, Greece.
Prodromos SidiropoulosRheumatology, Clinical Immunology and Allergy Department, Medical School University of Crete, 71110 Voutes, Heraklion, Greece. sidiropp@uoc.gr.ORCID 0000-0001-9607-0326

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRituximab is used for the treatment of active rheumatoid arthritis. In the present study, we examined the long-term flare risk and safety of reduced doses of rituximab. PATIENTS-

methodsThis was a prospective, observational, single-center study of patients starting rituximab on standard dose (SD). Patients were switched to low dose (LD) (1 g every 6 months), based on the treating rheumatologist's decision after having achieved sustained clinical responses, while the rest of the patients continued on standard dose (SD). During a 60-month period, we assessed (Kaplan-Meier survival analysis) the relapse rate (increase ≥ 1.2 in DAS28-ESR for ≥ 6 months) and discontinuations due to treatment failure in the low dose group, and we compared the incidence of serious adverse events (SAEs) between LD and SD groups.

resultsOut of 361 patients [females 83.4%, mean age 61.9 (10.6) years, seropositive 50.3%, median total comorbidities count 4], 81 patients (22.4%) entered LD in a median time of 24 months (95% CI 18-30 months). Seropositivity (OR 1.823), more than 2 previous bDMARDs failures (OR 0.428), and DAS28 < 4.88 at 6 months (OR 2.329) predicted the odds of entering LD (p < 0.05 for all). During 60 months of follow-up, only 7.5% of patients on LD relapsed. Patients on LD had significantly less SAEs and all-cause hospitalizations as compared to the SD group (p < 0.05 for all). Linear regression analysis showed that previous hospitalization while on bDMARDs (p < 0.0001), use of prednisolone > 5 mg/day while on rituximab (p < 0.0001), and a history of ≥ 2 previous csDMARDs (p = 0.041) predicted the risk of SAEs.

conclusionIn a cohort of patients with established RA and significant comorbidities who taper rituximab after substantial initial disease activity improvement, a low rate of relapses and lower risk of SAEs compared to SD were recorded. Seropositivity, a lower number of previous bDMARDs use, and lower DAS28 at 6 months predicted the probability of entering the LD regimen.

Indexed as

Arthritis, RheumatoidCohort StudiesFemaleHumansMiddle AgedPrednisoloneProspective StudiesRituximabPrednisoloneRituximabObservational studyRheumatoid arthritisRituximabTaper

Identifiers

PMID35655317
PMCPMC9161491

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Registered trials

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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.