Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study.

OBJECTIVES: To investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of nipocalimab in participants with moderate to severe active rheumatoid arthritis (RA) and inadequate response or intolerance to ≥1 antitumour necrosis factor agent. METHODS: In this phase 2a study, participants with RA seropositive for anticitrullinated protein antibodies (ACPA) or rheumatoid factors were randomised 3:2 to nipocalimab (15 mg/kg intravenously every 2 weeks) or placebo from Weeks 0 to 10. Efficacy endpoints (primary endpoint: change from baseline in Disease Activity Score 28 using C reactive protein (DAS28-CRP) at Week 12) and patient-reported outcomes (PROs) were assessed through Week 12. Safety, pharmacokinetics and pharmacodynamics were assessed through Week 18. RESULTS: 53 participants were enrolled (nipocalimab/placebo, n=33/20). Although the primary endpoint did not reach statistical significance for nipocalimab versus placebo, a numerically higher change from baseline in DAS28-CRP at Week 12 was observed (least squares mean (95% CI): -1.03 (-1.66 to -0.40) vs -0.58 (-1.24 to 0.07)), with numerically higher improvements in all secondary efficacy outcomes and PROs. Serious adverse events were reported in three participants (burn infection, infusion-related reaction and deep vein thrombosis). Nipocalimab significantly and reversibly reduced serum immunoglobulin G, ACPA and circulating immune complex levels but not serum inflammatory markers, including CRP. ACPA reduction was associated with DAS28-CRP remission and 50% response rate in American College of Rheumatology (ACR) criteria; participants with a higher baseline ACPA had greater clinical improvement. CONCLUSIONS: Despite not achieving statistical significance in the primary endpoint, nipocalimab showed consistent, numerical efficacy benefits in participants with moderate to severe active RA, with greater benefit observed for participants with a higher baseline ACPA. TRIAL REGISTRATION NUMBER: NCT04991753.

Efficacy of brief personcentered cognitive behavioral therapy to facilitate self-management for patients with Rheumatoid Arthritis: A mixed methods case series feasibility study / Eficacia de la terapia cognitivo conductual breve centrada en la persona para facilitar la autogestión de pacientes con artritis reumatoide: un estudio de la viabilidad de métodos mixtos para una serie de casos

The psychological consequences of living with rheumatoid arthritis (RA) are common. The objectives of this study were: (I) to investigate views of patients with RA about the provision of psychological support; (II) to study the efficacy of a person-centred cognitive behavioural therapy (CBT) self-management approach, including a health economic investigation. A mixed methods was applied: a formative qualitative interview study and a quantitative CBT intervention formed the case series feasibility study design, and a health economic investigation. The qualitative study highlighted that patients welcome emotional support. The CBT intervention from a small sample suggested that participants may have benefitted from the intervention until to the point of the follow-up. The results of the economic component need to be interpreted with caution in relation to service gaps. A broad approach in the delivery of a psychological intervention may benefit patients with long-term conditions. The practice implications are that RA patients may benefit from psychological interventions to cope better with their condition through personal intervention, and flexible appointment system. Intervention studies need to test this question in detail in the future

Las consecuencias psicológicas de vivir con artritis reumatoide (AR) son frecuentes. Los objetivos de este estudio fueron: (I) investigar las opiniones de los pacientes con AR acerca de la provisión de apoyo psicológico, (II) estudiar la eficacia de un enfoque de autogestión basado en la terapia cognitivo conductual (TCC) centrada en la persona, incluyendo una investigación económica de la salud. Se utilizaron métodos mixtos. Un estudio formativo de entrevista cualitativa y una intervención cuantitativa de TCC formaron el diseño del estudio de viabilidad de la serie de casos y una investigación económica de la salud. El estudio cualitativo destacó que los pacientes agradecen el apoyo emocional. La intervención de TCC con una pequeña muestra sugirió que los participantes podrían haberse beneficiado de la intervención hasta el seguimiento. Los resultados del componente económico deben interpretarse con precaución respecto a las carencias de los servicios. Un enfoque amplio en la prestación de una intervención psicológica puede beneficiar a los pacientes con dolencias a largo plazo. Las implicaciones prácticas son que los pacientes con AR pueden beneficiarse de intervenciones psicológicas para afrontar de mejor manera su enfermedad a través de una intervención personal y un sistema flexible de citas. Los estudios de intervención necesitan comprobar con detalle esta cuestión en el futuro