Prospective observational study of the long term hazards of biologic therapy in rheumatoid arthritis.
BSR-PsA – The British Society for Rheumatology Psoriatic Arthritis Register (BSR-PsA)
Summary: The study evaluates the long-term course of PsA and patients are followed up annually, comprising patient and treatment characteristics, clinical parameters, patient-defined benefit, quality of life and adverse events. In addition, patients starting a boDMARD, bsDMARD, or tsDMARD agent (either at recruitment or subsequently) will be followed up three and six months after the commencement of that therapy, with the follow-up schedule being ‘reset’ in the event of switching between therapies.
Questionnaire follow-up is tied to patients’ anticipated clinical visit schedule, and clinical centres are contacted regarding any patients lost-to-follow-up. Safety issues, serious adverse events and supplementary information are collected by standardised forms.
A biobank is also being created as part of the study. Where local facilities allow, participants may be asked to donate tissue samples (blood and urine) which, alongside the extensive clinical phenotyping, will help facilitate biomarker evaluation and the identification of specific bio-molecular predictors of treatment response.
Full title: BILAG Biologics Prospective Cohort: The Use of Novel Biological Therapies in the Treatment of Systemic Lupus Erythematosus (SLE)
Summary: The BILAG Biologics Prospective Cohort is a prospective observational cohort study of patients with SLE who are starting treatment with a biologic drug or a conventional, non-biologic therapy. The study aims to recruit 220 patients into the biologic treatment group and a further 220 patients into the conventional, non-biologic therapy cohort.
The aim of the BILAG BR is to ascertain whether using biologics in the routine treatment of SLE is associated with an increased risk of hospitalisation for infection, compared to SLE patients with similar disease activity receiving conventional therapies. The secondary purpose of the BILAG Biologics Prospective Cohort is to determine the long-term efficacy of biological therapies in the treatment of SLE.
This prospective cohort study will recruit an exposed cohort of patients with SLE treated with biological therapies and an unexposed cohort of patients with similar disease characteristics but exposed only to conventional non-biological therapies. Comprehensive data will be collected at baseline, from the clinic team and the patient, including data on disease diagnosis and activity, risk factors for infection and routine laboratory results. Follow-up data will be collected at 3, 6, 12, 24 and 36 months to include any changes in medications, adverse events, hospitalisations for infections, disease activity and quality of life along with biological samples for biomarker analysis.