Recipient organisationKing's College Hospital NHS Foundation Trust
Funding£2.0M
PeriodJan 2013 — Jun 2019
In plain English
AI plain-English summary
Rheumatoid arthritis patients with moderate symptoms are being offered a new two-phase treatment plan: short bursts of intensive therapy to force the disease into remission, followed by a gradual reduction to low maintenance doses. Most patients in specialist clinics have ongoing intermediate disease activity that current guidelines do not address well. Standard care leaves many with substantial disability. This programme tackles that gap by testing whether a "hit hard, then taper" approach can convert persistent moderate disease into lasting remission. If the trials and observational studies confirm the strategy works, the NHS could shift from managing chronic symptoms to actively inducing remission in the majority of patients. That would mean less disability, better quality of life, and reduced long-term costs from joint damage and work-related disability. The programme also develops patient-led strategies to help people tolerate and benefit from more intensive management, and includes health economic analysis to show whether the approach is affordable for routine NHS care.
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7.1 AIMS AND OBJECTIVESWe aim to improve outcomes for rheumatoid arthritis (RA) patients with intermediate disease activities. They form the majority of patients in specialist clinics. We believe the treatment paradigm needs changing for all patients. Short-term high intensity treatments should induce remission. Treatment should then be tapered to low maintenance levels. This approach should convert intermediate disease activity into remission resulting in less disability and better quality of life.Our research will span 3 work streams:a. Best for Patients - equipping patients to receive intensive management.b. Trial Evidence For Efficacy - trials and extension studies to show if intensive management and treatment tapering are effective.c. Real Life Evidence For Efficacy And Cost Effectiveness - supportive evidence from observational studies and systematic reviews.7.2 BACKGROUNDRA affects 580,000 English adults with 26,000 new diagnoses each year. Its follow-up involves 600,000 outpatient visits annually. Its annual direct NHS costs are £560M; work-related disability costs £1,800M.RA involves joint and systemic inflammation. Uncontrolled active RA causes disability and reduces quality of life. Disease modifying drugs (DMARDs), steroids and biologics like tumour necrosis factor inhibitors decrease disease activity and improve disability.National Institute for Health & Clinical Excellence (NICE) 2009 guidance outlined best practice for RA. It recommended intensive management for active, early RA. This gives remission in 30% of patients leaving most (50-60%) with ongoing intermediate disease activity. They often develop substantial disability. Our programme addresses this major evidence gap –optimal care for intermediate disease activity.7.3 RESEARCH PLANSThe programme has 3 work streams, each with an aim and specific themes.Work Stream A: Best For Patientsa. AimDeveloping patient-led implementation strategies to help patients with intermediate disease activity receive intensive management.b. Themes(i) Equipping patients to receive and potentially benefit from intensive management(ii) Understanding patients’ views on intensive management and tapering(iii) A partnership of patients and clinicians to implement intensive management in routine NHS careWork Stream B. Trial Evidence For Efficacya. AimTo show if intensive management is effective, and whether treatment tapering is possible in responders.b. Themes:(i) 12-month pragmatic open label multicentre randomised controlled trial with individual randomisation comparing intensive management with standard care in 358 RA patients with intermediate disease activity(ii) Assessing reasons for incomplete responses(iii) Pilot non-inferiority randomised controlled trial of treatment tapering in respondersWork Stream C: Real World Evidence For Efficacy And Affordabilitya. AimTo provide supportive evidence that intensive management will achieve sustained remissions, improve clinical outcomes and is cost effective.b. Themes:(i) Observational studies and completed trials: over 6000 RA patients followed for up to 10 years in 2 completed observational studies, 2 completed trials and 2 ongoing observational studies will provide data about how controlling intermediate disease activity affects disability(ii) The literature will be systematically reviewed to examine how changes in disease activity affect disability(iii) Health economic studies will use data from all stages of the programme to examine the impact of intensive management on costs and health outcomes as Quality Adjusted Life Years (QALYs)7.4 RESEARCH TEAMOur multidisciplinary team spans rheumatology, nursing, general practice, epidemiology, psychology, statistics, health economics, qualitative research, NHS management and includes two patients.The team have a strong publication record (over 400 relevant papers) and a good track record in obtaining and delivering peer-reviewed grants (>£15M current/recent funding). They have delivered key
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