OP0053 THE EFFECTS OF RITUXIMAB ON QUALITY OF LIFE, PAIN AND MOBILITY SCORES IN THE PRECLINICAL PHASE OF RHEUMATOID ARTHRITIS: 2 YEAR DATA FROM THE PRAIRI STUDY
Authors: G. Frazzei, S. Cramer, R. Landewé, K. Maijer, D. Gerlag, P. P. Tak, N. De Vries, L. G. M. Van Baarsen, R. F. Van Vollenhoven, S. W. Tas
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Over the past 10 years, several trials have investigated prevention of rheumatoid arthritis (RA) by biological disease modifying antirheumatic drug (DMARD) therapies. Early treatment in RA-risk individuals in the preclinical phase – i.e. before the disease has been fully established – has the potential to prevent disease or delay its onset, which may have a positive impact on both patient and society. The PRAIRI study was a randomized, double-blind, controlled trial in which seropositive arthralgia patients received a single dose of rituximab (RTX) or placebo (PBO). This resulted in a significant delay of arthritis development of up to 12 months [1]. Secondary outcomes were the effects of RTX treatment on quality of life as measured by various patient reported outcomes (PROs). <h3>Objectives:</h3> To evaluate the impact of RTX treatment on the quality of life of RA-risk individuals in the PRAIRI study as measured by various patient reported outcomes (PROs). <h3>Methods:</h3> Eighty-one RA-risk individuals were included in the PRAIRI study between 2010 and 2013, and treated with one single dose of either PBO or 1000 mg RTX; all study subjects also received standard co-medication, consisting of 100 mg methylprednisolone and anti-histamines. 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. <h3>Results:</h3> PRO data were available for 78 patients. No convincing effect on VAS pain, HAQ score, EQ-5D, or PCS and MCS of SF-36 was found in either RTX or PBO groups. Compared to the PBO group, the RTX group had slightly worse baseline scores for VAS pain (mean ± SEM: PBO = 23.11 ± 3.68; RTX = 30.88 ± 3.41) and HAQ score (PBO = 0.26 ± 0.06; RTX = 0.56 ± 0.09). However, baseline PRO scores were similar to the general "healthy" population and remained stable during the two-year follow up period for both RTX and PBO group (Figure 1A). At the time of arthritis development, we also did not observe a significant difference in 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 (Figure 1B) compared to baseline. <h3>Conclusion:</h3> A single dose of RTX in RA-risk individuals delayed the onset of arthritis by a year, but did not have a positive 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 can prevent RA. <h3>REFERENCES:</h3> [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. <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> Giulia Frazzei: None declared, Sophie Cramer: None declared, Robert Landewé: None declared, Karen Maijer: None declared, Danielle Gerlag: None declared, Paul Peter Tak: None declared, Niek de Vries: None declared, Lisa G.M. van Baarsen: None declared, Ronald F. van Vollenhoven Consultancy and/or speaker: AbbVie, AstraZeneca, Biogen, BMS, Galapagos, GSK, Janssen, Pfizer, RemeGen, UCB, Support for Research or Educational programs (institutional grants): AstraZeneca, BMS, Galapagos, MSD, Novartis, Pfizer, Roche, Sanofi, UCB, Sander W. Tas: None declared.