Lancet Rheumatology最新文献

Background: To ensure that digital health applications reflect real-world needs and preferences, meaningful public and patient involvement is essential throughout the design process. However, existing patient and public involvement frameworks often fall short in guiding the fast-paced, iterative nature of digital health innovations. This study aimed to examine how patient and public involvement was embedded in the development and real-world testing of MyRA, a web-based self-monitoring application designed for and with people with rheumatoid arthritis, and explored the impact of this involvement.

Methods: We used a multimethod, qualitative approach with retrospective analysis of multiple data sources. Documents from focus groups and co-creation sessions were used to examine the timing, form, and influence of patient and public involvement on design. A post-study questionnaire captured real-world experiences with MyRA. Steering group meeting notes assessed alignment with European Alliance of Associations for Rheumatology (EULAR) recommendations for involvement of patient research partners in research. Reflective steering group meetings provided further insights. All findings were synthesised and triangulated using inductive and deductive analyses.

Findings: Patient research partners and experts by experience were involved throughout the project and influenced key design decisions. The post-study questionnaire revealed both positive experiences and challenges, including varied engagement patterns and preferences for application features. Overall, involvement of patient research partners in the project aligned well with the EULAR recommendations, and collaboration was seen as valuable, although sometimes complex. These insights informed a set of practice-informed considerations for meaningful patient and public involvement in digital health research.

Interpretation: Continuous patient and public involvement across application development phases can strengthen digital health innovation but requires broader user validation beyond a core group, managing different stakeholder perspectives and expectations, and ensuring clear structures for collaboration. The findings offer practical considerations to tailor patient and public involvement frameworks for use in iterative, fast-moving digital health contexts.

Funding: Health Holland.

Background: Clinical trials aimed at preventing rheumatoid arthritis in individuals at risk have had variable results. The long-term outcomes of disease interception, however, are not known. We aimed to examine the long-term effect of therapeutic intervention, with emphasis on efficacy and safety.

Methods: The Arthritis Prevention In the Preclinical Phase of Rheumatoid arthritis with Abatacept (APIPPRA) phase 2b, randomised controlled trial recruited 213 anti-citrullinated protein antibody (ACPA) positive individuals with arthralgia in 28 hospital-based early arthritis clinics in the UK and three in the Netherlands, randomly assigning participants to 52 weekly subcutaneous injections of 125 mg abatacept (n=110) or placebo (n=103), with another 52 weeks of follow-up. The APIPPRA Long-Term Outcome (ALTO) study extended follow-up for between 4 and 8 years and study participants and clinical assessors remained masked to treatment group. The primary outcome was the time from randomisation to development of clinical synovitis in at least three joints, rheumatoid arthritis according to American College of Rheumatology-European Alliance of Associations for Rheumatology 2010 criteria, or first treatment with disease modifying anti-rheumatic drugs, whichever was met first. The primary outcome was also stratified by autoantibody profiles defined at the time of randomisation. People with lived experience of rheumatoid arthritis had input into the APIPPRA study design. The study was registered at ISRCTN (ISRCTN-12680338), and is completed.

Findings: Between April 26, 2021, and Jan 31, 2023, 143 APIPPRA study participants enrolled in ALTO: 71 in the abatacept group and 72 in the placebo group (mean age 48·2 years [SD 11·2], 112 [78%] females, 31 [22%] males, 116 [81%] White). Median follow-up time from randomisation was 55 months (IQR 23-74). Primary events increased by 54 to 119. The initial between-group difference in restricted mean arthritis-free survival time observed at 2 years in APIPPRA remained significant at 4 years (4·9 months 95% CI 0·1-9·6; p=0·044), although the magnitude of this difference diminished over time. Assessments of disease activity and patient reported outcomes revealed no significant differences between groups beyond the treatment period. However, although participants with a broad autoantibody profile at baseline were at highest risk of progressing, this subgroup responded better to abatacept. There were 18 serious adverse events in the abatacept group and 13 in the placebo group; none deemed related to study drug.

Interpretation: In this at-risk population, 1-year treatment with abatacept delayed progression to rheumatoid arthritis for up to 4 years. Those at highest risk of progression have a broad autoantibody profile but are more responsive to abatacept treatment.

Funding: Bristol Myers Squibb.

Glucocorticoid pulse therapy is commonly prescribed by rheumatologists worldwide for a wide variety of serious and potentially life-threatening diseases. Pulse therapy also has the potential to lower the cumulative glucocorticoid burden, which has already been proven in systemic lupus erythematosus and giant cell arteritis. The standard practice in rheumatology is to administer this therapy intravenously, but current literature suggests that oral methylprednisolone is a non-inferior option for clinical outcomes and safety. Integrating oral methylprednisolone pulse therapy into rheumatological practice might have considerable benefits, not only for patients but also for society as a whole. In this Viewpoint, we provide a review of oral methylprednisolone pulse therapy covering pharmacology, safety, patient preference, sustainability, and its possible use in rheumatology practice. We aim to increase awareness among rheumatologists of the potential use of oral glucocorticoid pulse therapy as this modest change in clinical practice has major benefits.