Session Information
Session Type: Poster Session C
Session Time: 10:30AM-12:30PM
Background/Purpose: Over the past 10 years, several trials have investigated prevention of rheumatoid arthritis (RA) by disease modifying antirheumatic drug (DMARD) therapies. Early treatment of individuals at risk of developing rheumatoid arthritis (RA-risk) in the pre-clinical phase has the potential to positively impact both patients and society by preventing disease onset and improving quality of life. The PRAIRI study was a randomized, double-blind, placebo-controlled trial in which IgM-RF and/or anti-CCP seropositive arthralgia individuals received a single dose of rituximab (RTX) or placebo (PBO). This resulted in a significant delay of arthritis development of 12 months at the point when 25% of subjects developed RA (1). Here, we report our findings on patient reported outcomes (PROs) in this study population.
Methods: Eighty-one RA-risk individuals were treated with one single dose of either PBO or 1000mg RTX plus 100mg methylprednisolone (MP) and anti-histamines as co-medication. Data on quality of life were collected at baseline and 1, 4, 6, 12, and 24 months using the following PRO-questionnaires: visual analogue scale (VAS) pain, health assessment questionnaire (HAQ) score, EuroQol five dimension (EQ-5D), and both physical component score (PCS) and mental component score (MCS) of the 36-item short form heath survey (SF-36). Changes in quality of life over time and potential impact on perceived arthritis severity at onset of clinically overt disease were analyzed for both treatment groups.
Results: PRO data were available for 78 patients. No significant effects on VAS pain, HAQ score, EQ-5D, or PCS and MCS of SF-36 were found in either RTX or PBO groups. At the time of clinically manifest disease (arthritis), also no significant difference on perceived arthritis severity between groups was observed, as reported by VAS pain (mean ± SEM: PBO = 51.29 ± 5.99; RTX = 55.83 ± 6.76), HAQ score (PBO = 0.86 ± 0.20; RTX = 0.93 ± 0.15), EQ-5D (PBO = 0.64 ± 0.05; RTX = 0.63 ± 0.06), PCS (PBO = 39.63; ± 3.08; RTX = 41.13 ± 2.54) or MCS (PBO = 50.91 ± 1.83; RTX = 48.31 ± 3.93) of the SF-36 questionnaire.
Conclusion: A single dose of RTX in RA-risk individuals delayed the onset of arthritis, but did not have an impact on quality of life as measured by various PROs. In RA-risk individuals developing arthritis, RTX also did not significantly alter PROs and/or perceived disease severity at the time of arthritis development. Since RTX did not have a negative effect on quality of life either, these data underscore that RTX treatment is well-tolerated in the preclinical phase of RA but additional research is required to determine whether RTX based strategies or other B cell targeting therapies can prevent RA and/or have a positive impact on quality of life.
References:
1. Gerlag DM et al., “Effects of B-cell directed therapy on the preclinical stage of rheumatoid arthritis: the PRAIRI study”, Ann Rheum Dis. 2019 Feb;78(2):179-185.
To cite this abstract in AMA style:
Frazzei G, Cramer S, Landewé R, Maijer K, Gerlag D, Tak, MD PhD P, De Vries N, van Baarsen L, Van Vollenhoven R, Tas S. Two Year Data on Quality of Life, Pain and Mobility Scores After Rituximab Treatment in the Preclinical Phase of Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/two-year-data-on-quality-of-life-pain-and-mobility-scores-after-rituximab-treatment-in-the-preclinical-phase-of-rheumatoid-arthritis/. Accessed .« Back to ACR Convergence 2024
ACR Meeting Abstracts - https://acrabstracts.org/abstract/two-year-data-on-quality-of-life-pain-and-mobility-scores-after-rituximab-treatment-in-the-preclinical-phase-of-rheumatoid-arthritis/