Dr. Michele Doran (1) Prof. David Kane (2) Prof. Douglas Veale (3) Ms. Phil Gallagher (3) Prof. Gerry Wilson (4)
1. St. James's Hospital 2. AMNCH Tallaght 3. St. Vincent's University Hospital 4. University College Dublin
Biologics registries have been in existence in many other European countries for more than 10 years. These large epidemiological cohort studies evaluate unselected patients treated in routine care, and have yielded valuable information regarding biologic therapies in RA.
RABRI was established in Ireland in 2015 to document information regarding patients with Rheumatoid Arthritis (RA) commencing a new biologic (including biosimilar) therapy in participating centres in Ireland. The aims of RABRI are to monitor response to therapy, safety, and to record adverse events and events of special interest.
A RABRI Steering Committee was established within the Irish Society for Rheumatology, consisting of 5 ISR Members. Data collection tools were drawn up and an electronic database was established, in which anonymised data is stored electronically. Ethical approval was obtained in each participating centre. All patients entering RABRI are reviewed at baseline (starting 1st biologic or changing biologic), at 6-monthly intervals for the 1st 2 years and yearly thereafter for 5 years.
Data collected includes demographics, factors relating to RA, use of other DMARDS and steroids, and comorbidities. Disease activity is assessed at each visit using validated tools including CDAI, SDAI, PROMIS-HAQ and DAS.
Enrolment started in early 2016. To date 6 centres have commenced enrolling patients and further 4 have approval. A total of 107 patients have been enrolled and a total of 120 visits have been recorded (42 2nd visits and 8 3rd visits)
Of the patients enrolled to date, a total of 70 (65%)were starting their first biologic. Of these, 38 were prescribed etanercept, 18 adalimumab, 15 abatacept, 14 tocilizumab, 11 rituximab,7 golimumab,2 certolizumab, and 1 each infliximab and baricitinib.
A total of 9 biologic therapies have been included to date and 7 switches have taken place.
In the patients with recorded follow-up visits, disease activity, measured by all indices dropped between first and subsequent visits. CDAI (Table 1) and SDAI (Table 2) dropped between first and subsequent visits. Average DAS score on the 1st visit was 5.27 and on 2nd visit it was 3.52.
Four patients have had events of special interest to date. Two patients experienced, malignancy, one patient experienced aplastic anaemia with pancytopaenia, and one experienced a serious skin reaction.
This is the first study examining biologics use in Ireland, and early results show a similar pattern of biologic use to that reported by other European registries.The number of events of special interest is small and is within the expected range based on similar registries.