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

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Abstract

Objective

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

Methods

Data 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.

Results

Drug 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).

Conclusions

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

Trial Registration

ClinicalTrials.gov Identifier: NCT01581294.

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Data availability

Data are available from the corresponding author on reasonable request.

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Authors and Affiliations

  1. Section for Rheumatology, Department for Neurology, Rheumatology and Physical Medicine, Helse Førde, Svanehaugevegen 1, 6812, Førde, Norway

    Pawel Mielnik

  2. Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway

    Joseph Sexton, Elisabeth Lie, Eirik K. Kristianslund & Tore K. Kvien

  3. Department of Rheumatology, University Hospital of Northern Norway, Tromsø, Norway

    Gunnstein Bakland

  4. Lillehammer Hospital for Rheumatic Diseases, Lillehammer, Norway

    Liz P. Loli

  5. Department of Rheumatology, St. Olavs Hospital, Trondheim, Norway

    Erik Rødevand

  6. Department of Rheumatology, Vestre Viken/Drammen Hospital, Drammen, Norway

    Åse S. Lexberg

  7. Faculty of Medicine, University of Oslo, Oslo, Norway

    Tore K. Kvien

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  1. Pawel Mielnik
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Corresponding author

Correspondence to Pawel Mielnik.

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Funding

No funding was received for the conduct of this study or preparation of this article.

Conflict of interest

Tore K. Kvien has received fees for speaking and/or consulting from AbbVie, Biogen, Celltrion, Egis, Eli Lilly, Hikma, MSD, Mylan, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, Sanofi, and UCB and has received research funding to Diakonhjemmet Hospital from AbbVie, BMS, MSD, Pfizer, Roche and UCB. Gunnstein Bakland has received speakers fees from Novartis and Abbvie and is on the advisory board for Pfizer, Novartis and Celgene. Pawel Mielnik, Joseph Sexton, Elisabeth Lie, Liz P. Loli, Eirik K. Kristianslund, Erik Rødevand and Åse S. Lexberg have no conflicts of interest that are directly relevant to the content of this article.

Ethical approval

NOR-DMARD has been approved by the local ethics committee (REK sør-øst, 2011/1339), the Data Inspectorate and the Norwegian Medicines Agency.

Consent to participate

All patients signed the informed consent form.

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Mielnik, P., Sexton, J., Lie, E. et al. Does Older Age have an Impact on Rituximab Efficacy and Safety? Results from the NOR-DMARD Register. Drugs Aging 37, 617–626 (2020). https://doi.org/10.1007/s40266-020-00782-x

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  • DOI: https://doi.org/10.1007/s40266-020-00782-x

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