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Background: 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). Objectives: 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). Methods: 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. Results: 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. Conclusion: 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. 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. Acknowledgements: NIL. Disclosure of Interests: 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.
Frazzei et al. (Sat,) studied this question.