A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis.

OBJECTIVES: In RA, telemedicine may allow tight control of disease activity while reducing hospital visits. We developed a smartphone application connected with a physician's interface to monitor RA patients. We aimed to assess the performance of this e-Health solution in comparison with routine practice in the management of patients with RA. METHODS: A six-month pragmatic, randomized, controlled, prospective, clinical trial was conducted in RA patients with high to moderate disease activity starting a new DMARD therapy. Two groups were established: 'connected monitoring' and 'conventional monitoring'. The primary outcome was the number of physical visits between baseline and six months. Secondary outcomes included adherence, satisfaction, changes in clinical, functional and health status scores (Short-Form 12). RESULTS: Of the 94 randomized patients, 89 completed study: 44 in the 'conventional monitoring' arm and 45 in the 'connected monitoring' arm. The total number of physical visits between required baseline and six-month visits was significantly lower in the 'connected monitoring' group [0.42 (0.58) vs 1.93 (0.55); P <0.05]. No differences between groups were observed in the clinical and functional scores. A better quality of life for Short-Form 12 subscores (Role-Physical and Role-Emotional) were found in the 'connected monitoring' group. CONCLUSION: Our results suggest that connected monitoring reduces the number of physical visits while maintaining a tight control of disease activity and improving quality of life in patients with RA starting a new treatment. TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT03005925.

Low Influenza, Pneumococcal and Diphtheria-Tetanus-Poliomyelitis Vaccine Coverage in Patients with Primary Sjögren's Syndrome: A Cross-Sectional Study.

:Objective: To evaluate vaccination coverage and reasons for non-vaccination in patients with primary Sjögren's syndrome (pSS). Method: A total of 111 patients fulfilling American-European Consensus Group criteria for pSS were interviewed by use of a standardized questionnaire between January 2016 and November 2017 in two French tertiary referral centers for auto-immune diseases. Results: Updated immunization coverage for influenza was 31.5% (n = 35), pneumococcus was 11.7% (n = 13), and diphtheria-tetanus-poliomyelitis (DTP) was 24.3% (n = 27). The main reasons for non-vaccination were fear of side effects from the influenza vaccine (40.3%) and a lack of proposal for the pneumococcal vaccine (72.3%). In vaccinated patients, vaccination was mainly proposed by general practitioners for the influenza vaccine (42.6%) and rheumatologists for the pneumococcal vaccine (41.2%). Probability of influenza vaccination was associated with age (odds ratio/year (OR) 1.04, 95% confidence interval (CI) 1.0-1.1; p = 0.016), history of severe infection (OR 15.9, 95% CI 1.35-186; p = 0.028), low EULAR Sjögren's syndrome disease activity index (OR 0.85, 95% CI 0.75-0.96; p = 0.013), and comorbidities (OR 3.52, 95% CI 1.22-10.2; p = 0.02). Probability of vaccination against pneumococcus was associated with lung comorbidities (OR 3.83, 95% CI 1.11-13.12; p = 0.033) and up-to-date influenza vaccination (OR 3.71, 95% CI 1.08-12.8; p = 0.038). Conclusion: Influenza, pneumococcal, and DTP vaccine coverage was low in patients with pSS included in this study. These results underline the relevance of systematically screening vaccine status in pSS patients and educating patients and physicians on the need for vaccination to improve vaccine coverage in this population.

Efficacy and safety of biological DMARDs modulating B cells in primary Sjögren's syndrome: Systematic review and meta-analysis.

OBJECTIVE: In this review, we summarise the clinical efficacy and safety of B-cell targeted therapies for primary Sjögren's syndrome (pSS). METHODS: A systematic literature review was conducted using databases including MEDLINE, EMBASE and Cochrane. Only articles reporting controlled or prospective studies of b-DMARDs modulating B cells in treatment of pSS were selected. The highest-quality studies were selected for meta-analysis. The primary outcome of interest was clinical efficacy at week 24 on fatigue, dryness, Schirmer test, salivary flow rate and the full ESSDAI score including biological domain. For the efficacy criteria used, the difference between rituximab and placebo groups was expressed as mean difference (MD). RESULTS: Eighteen articles (13 of rituximab, 3 of belimumab, 1 of epratuzumab and 1 of baminercept) were identified for detailed evaluation. 4 controlled randomised trials of rituximab treatment vs. placebo involving 300 patients were included for quantitative analysis. No significant differences were observed between groups in the meta-analysis of mean improvements between baseline and week 24 in fatigue VAS [MD -3,24 95% CI (-30,21 to 23,72)], oral dryness VAS [MD -8,41 95% CI (-35,06 to 18,24)], salivary flow rate [MD 0,04 95% CI (-0,03 to 0,11)] and Schirmer test [MD 0,35 95% CI (-2,13 to 2,82)]. Rituximab was relatively safe compared to placebo. CONCLUSION: Our review shows that rituximab is not effective in pSS with the designs and outcomes proposed in the trials. Controlled randomised trials are needed to prove the efficacy of belimumab and epratuzumab in this indication. The randomised controlled trial evaluating baminercept failed to achieve its primary endpoint.