Disease activity and patient-reported outcomes in patients with rheumatoid arthritis and Sjögren’s syndrome enrolled in a large observational US registry

Abstract

The objective of this study was to compare rheumatoid arthritis (RA) disease activity and patient-reported outcomes (PROs) in a national sample of patients with RA with/without Sjögren's syndrome (SS). Adults with RA from a large observational US registry (Corrona RA) with known SS status between 22 April 2010 and 31 July 2018 and a visit 12 (± 3) months after index date were identified (n = 36,256/52,757). SS status: determined from a yes/no variable reported at enrolment into the Corrona RA registry and follow-up visits. Index date: date that SS status was recorded (yes/no). Patients received biologic or targeted synthetic disease-modifying antirheumatic drugs as part of standard care. Patients with RA only were followed for ≥ 12 months to confirm the absence of SS. Patients were frequency-and propensity-score matched (PSM) 1:1 and stratified by disease duration and treatment response-associated variables, respectively. Clinical Disease Activity Index (CDAI) and PROs 12 months after index visit were compared in patients with and without SS. Baseline characteristics in 283 pairs of PSM patients were balanced. Mean change in CDAI score was numerically lower in patients with RA and SS than patients with RA only (8.8 vs 9.3). Reductions in PROs of pain, fatigue and stiffness were two-to threefold lower for patients with RA and SS versus RA only. Reductions in RA disease activity and RA-related PROs were lower in patients with RA and SS versus those with RA only. Our data indicate that SS adds to treatment challenges; physicians may wish to consider SS status when managing patients with RA.

Real-world data and evidence in pain research: a qualitative systematic review of methods in current practice

“…The studies identified were remarkably similar: 49 of 65 reported on surgical interventions; of the remaining16; 3 studied alternative treatments 8,25,29 ; 4 studied epidemiological risk factors like obesity, 22 old age, 21 opioid abuse, 23 and smoking 43,59 ; only 4 studies investigated pharmacological interventions 28,67,71,81 ; the remaining studied patient-professional-interaction or behavioural medicine, 19,66 radiotherapy, 49 implants, 69 or compared 2 disease progressions under routine care. 26 Of the 49 studies on surgical interventions, 23 focussed on postsurgical pain, with 3 investigating chronic postsurgical pain. 11,65,80 Very few studies mentioned a study registration 13 or provided a link or identifier of a publicly accessible protocol in a central register.…”

“…Surprisingly, in this systematic search trying to identify real-word data and evidence studies, only 6 reports used the term “real-world data” in the full text, 26 , 28 , 29 , 71 , 79 , 87 only one used the term “real-world evidence”, 28 and only 2 studies used the term “real-world” in the title. 28 , 71 Despite no time filter in our search, most studies were conducted recently, with only one published in 2009, 66 7 in 2014 to 16, 31 in 2017 to 2019, and 26 since 2020.…”

“…Based on our inclusion/exclusion criteria, through full-text screening, we i denti fi ed 61 studi es for inclusi on. 1,3,[6][7][8]11,[13][14][15]21,22,[24][25][26][27][28][29][30][31][34][35][36][37][38][39][40][41][44][45][46][49][50][51][52][53][54][55][56][57][58][59][60][61][63][64][65][66][67][69][70][71][72]…”

Corneal complications of rheumatoid arthritis

“…Although KCS and sSS are not considered severe EAM [42], patients with both RA and sSS have an increased disease burden, decreased quality of life, are more likely to have a longer duration of RA, worse joint damage and lower reduction in RA disease activity at 12 months compared with patients with RA only [43][44][45]. The correlation of sSS with increased RA disease burden includes an association with higher RA disease activity and ACPA positivity, which indicates a poor prognosis [43,46].…”

“…There are no current guidelines recommendations for treating patients with both RA and sSS [45], and there is a paucity of studies on outcomes on RA-related KCS with systemic therapy. Hydroxychloroquines, corticosteroids, rituximab, anti-TNF agents, methotrexate and others showed to improve KCS features in SS.…”