Evidence map›Paper›PMID 32648248›Full record

Observational studyDrugs & aging2020

Does Older Age have an Impact on Rituximab Efficacy and Safety? Results from the NOR-DMARD Register.

Pawel Mielnik, Joseph Sexton, Elisabeth Lie, Gunnstein Bakland, Liz P Loli, Eirik K Kristianslund, Erik Rødevand, Åse S Lexberg, Tore K Kvien

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Drugs & aging, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01581294 (Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 10% 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.

NCT01581294 recruitingnot on this map

Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study

TypeobservationalSponsorDiakonhjemmet HospitalRan2012 to 2050Enrolled15,000ConditionsInflammatory Joint Diseases
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
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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

9 authors at 6 institutions in 1 country.

Pawel MielnikSection for Rheumatology, Department for Neurology, Rheumatology and Physical Medicine, Helse Førde, Svanehaugevegen 1, 6812, Førde, Norway. pawel.franciszek.mielnik@helse-forde.no.ORCID http://orcid.org/0000-0002-3894-5371
Joseph SextonDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Elisabeth LieDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Gunnstein BaklandDepartment of Rheumatology, University Hospital of Northern Norway, Tromsø, Norway.
Liz P LoliLillehammer Hospital for Rheumatic Diseases, Lillehammer, Norway.
Eirik K KristianslundDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Erik RødevandDepartment of Rheumatology, St. Olavs Hospital, Trondheim, Norway.
Åse S LexbergDepartment of Rheumatology, Vestre Viken/Drammen Hospital, Drammen, Norway.
Tore K KvienDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Diakonhjemmet Hospital · NODrammen Hospital · NOHelse Førde · NOSt Olav's University Hospital · NOUniversity Hospital of North Norway · NOUniversity of Oslo · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective of this study was to compare the efficacy and safety of rituximab in older vs younger patients with rheumatoid arthritis.

methodsData on 367 patients with rheumatoid arthritis treated with rituximab in the Norwegian Disease-Modifying Antirheumatic Drug (NOR-DMARD) register were analysed, comparing patients aged ≥ 65 years (n = 91) with patients aged < 65 years (n = 276). Drug survival was compared using a Kaplan-Meier analysis and Cox proportional hazard models. Disease activity, as assessed by the Disease Activity Score based on 28 joints and erythrocyte sedimentation rate (DAS28-ESR) and the Simplified Disease Activity Index, was analysed with linear mixed models. The occurrence of adverse events was analysed by quasi-Poisson regression models.

resultsDrug survival was similar in the two age groups. The proportion of patients who remained taking rituximab over 2 years was 72% in those under aged 65 years vs 74% in those aged ≥ 65 years. No statistically significant association with age was found for drug survival in either the unadjusted (hazard ratio 1.13, p = 0.65) or adjusted Cox proportional hazard analyses for the model with DAS28-ESR as a confounder (effect size 1.11, p = 0.73). Models including the Simplified Disease Activity Index instead of DAS28-ESR yielded similar results. Age was furthermore not significantly associated with disease activity over time, although there was a tendency towards a poorer response in older patients. In the older age group, there was a higher incidence of pneumonia (107 vs 51 per 1000 patient-years) and other serious infections (142 vs 66 per 1000 patient-years).

conclusionsRituximab is a reasonable therapeutic option for older patients with rheumatoid arthritis although vigilance is needed with regard to the infection profile.

trial registrationClinicalTrials.gov Identifier: NCT01581294.

Indexed as

AdultAgedAge FactorsAntirheumatic AgentsArthritis, RheumatoidDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunosenescenceMaleMiddle AgedNorwayRegistriesRituximabSeverity of Illness IndexTreatment OutcomeAntirheumatic AgentsRituximab

Identifiers

PMID32648248
OpenAlexW3041365015

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.