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Randomized Controlled Trial
. 2024 Oct 18;10(4):e004622.
doi: 10.1136/rmdopen-2024-004622.

The effect of rituximab on patient reported outcomes in the preclinical phase of rheumatoid arthritis: 2 year data from the PRAIRI study

Giulia Frazzei  1   2 , Sophie H M Cramer  1 , Robert B M Landewé  1   2   3 , Karen I Maijer  4 , Danielle M Gerlag  1   5 , Paul P Tak  1   6   7 , Niek de Vries  1   2 , Lisa G M van Baarsen  1   2 , Ronald F van Vollenhoven  1   2 , Sander W Tas  8   2
Affiliations
Randomized Controlled Trial

The effect of rituximab on patient reported outcomes in the preclinical phase of rheumatoid arthritis: 2 year data from the PRAIRI study

Giulia Frazzei et al. RMD Open. .

Abstract

Objectives: Early treatment of individuals at risk of developing rheumatoid arthritis (RA-risk) in the preclinical phase has the potential to positively impact both patients and society by preventing disease onset and improving patients' quality of life. The PRAIRI study was a randomised, double-blind, placebo-controlled trial with the B-cell depleting agent rituximab (RTX), which resulted in a significant delay of arthritis development of up to 12 months in seropositive RA-risk individuals. Here, we report our findings on patient-reported outcomes (PROs) in this study population.

Methods: Seventy-eight RA-risk individuals were treated with one single dose of either placebo (PBO) or 1000 mg RTX plus 100 mg methylprednisolone (MP) and anti-histamines, regardless of treatment allocation, as co-medication. Data on quality of life were collected at baseline and 1, 4, 6, 12 and 24 months using established PRO questionnaires (visual analogue scale (VAS) pain, health assessment questionnaire disability index (HAQ-DI) score, EuroQol five dimension (EQ-5D) and both physical and mental component score of the 36-item short-form heath survey (SF-36)).

Results: No significant changes in quality of life over a 2 year follow-up were observed in at-risk individuals treated with RTX compared to PBO given the PRO scores at 24 months (mean difference±SEM: HAQ score=0.07±0.16; EQ-5D=-0.02±0.05; VAS pain=11.11±7.40). Furthermore, no significant effect of treatment on perceived arthritis severity at the time of clinically manifest disease (arthritis) was found.

Conclusion: One single dose of RTX plus MP administered to RA-risk individuals does not have a meaningful and measurable positive effect on PROs after 2 years of follow-up and/or perceived disease severity at the time of arthritis development.

Trial registration number: Trial registered at EU Clinical Trial Register, EudraCT Number: 2009-010955-29 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=Prevention+of+RA+by+B+cell+directed+therapy).

Keywords: Arthritis, Rheumatoid; Patient Reported Outcome Measures; Rituximab.

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Conflict of interest statement

Competing interests: GF, SHMC, RBML, KIM, DMG, PPT, NdV and LGMvB report no conflict of interest. RFvV reports institutional grants from AstraZeneca, BMS, Galapagos, MSD, Novartis, Pfizer, Roche, Sanofi and UCB, as well as institutional fees from AbbVie, AstraZeneca, Biogen, BSM, Galapagos, GSK, Janssen, Pfizer, RemeGen and UCB, all outside the submitted work. SWT reports institutional grants from GSK, Lilly, Celgene, Pfizer, Roche, AstraZeneca, Galapagos, Citryll and Galvani bioelectronics, as well as institutional fees from NovoNordisk, Pfizer, AbbVie and UCB, all outside the submitted work.

Figures

Figure 1
Figure 1. Patient reported outcomes (PROs) for the 2 year follow-up after a single infusion of rituximab or placebo. PRO scores for health assessment questionnaire disability index (HAQ-DI) score, EuroQol five dimension (EQ-5D) questionnaire, visual analogue scale (VAS) pain, physical component score (PCS) and mental component score (MCS) of 36-item short-form heath survey (SF-36) questionnaire, stratified for treatment (n at baseline: placebo (PBO)=37; rituximab (RTX)=41), reported as mean±SEM. PRO scores are shown for a 2 year period (PBO=red line; RTX=blue line).
Figure 2
Figure 2. Patient-reported outcomes (PROs) in patients who developed arthritis. PRO scores for health assessment questionnaire disability index (HAQ-DI) score, EuroQol five dimension (EQ-5D) questionnaire, visual analogue scale (VAS) pain, physical component score (PCS) and mental component score (MCS) of the 36-item short-form heath survey (SF-36) questionnaire, stratified for treatment (n placebo (PBO)=14; n rituximab (RTX)=12) at baseline and arthritis visit are shown for patients who developed rheumatoid arthritis (RA) within the study period. Median (IQR) time of RA onset was 12.0 (2.0–15.0) months in the PBO group and 16.5 (9.75–28.0) in the RTX group (PBO=red line; RTX=blue line).
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References

    1. Kinslow JD, Blum LK, Deane KD, et al. Elevated IgA Plasmablast Levels in Subjects at Risk of Developing Rheumatoid Arthritis. Arthritis Rheumatol . 2016;68:2372–83. doi: 10.1002/art.39771. - DOI - PMC - PubMed
    1. Verheul MK, Böhringer S, van Delft MAM, et al. Triple Positivity for Anti-Citrullinated Protein Autoantibodies, Rheumatoid Factor, and Anti-Carbamylated Protein Antibodies Conferring High Specificity for Rheumatoid Arthritis: Implications for Very Early Identification of At-Risk Individuals. Arthritis Rheumatol . 2018;70:1721–31. doi: 10.1002/art.40562. - DOI - PubMed
    1. Volkov M, Kampstra ASB, van Schie KA, et al. Evolution of anti-modified protein antibody responses can be driven by consecutive exposure to different post-translational modifications. Arthritis Res Ther. 2021;23:298. doi: 10.1186/s13075-021-02687-5. - DOI - PMC - PubMed
    1. Tak PP, Smeets TJ, Daha MR, et al. Analysis of the synovial cell infiltrate in early rheumatoid synovial tissue in relation to local disease activity. Arthritis Rheum. 1997;40:217–25. doi: 10.1002/art.1780400206. - DOI - PubMed
    1. Cohen SB, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti–tumor necrosis factor therapy: Results of a multicenter, randomized, double‐blind, placebo‐controlled, phase III trial evaluating primary efficacy and safety at twenty‐four weeks. Arthritis Rheum . 2006;54:2793–806. doi: 10.1002/art.22025. - DOI - PubMed

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