Eligibility for clinical trials in primary Sjögren's syndrome: lessons from the UK Primary Sjögren's Syndrome Registry.
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Oni Clare, Mitchell Sheryl, James Katherine, Ng Wan-Fai, Griffiths Bridget, Hindmarsh Victoria, Price Elizabeth, Pease Colin T, Emery Paul, Lanyon Peter, Jones Adrian, Bombardieri Michele, Sutcliffe Nurhan, Pitzalis Costantino, Hunter John, Gupta Monica, McLaren John, Cooper Annie, Regan Marian, Giles Ian, Isenberg David, Saravanan Vadivelu, Coady David, Dasgupta Bhaskar, McHugh Neil, Young-Min Steven, Moots Robert, Gendi Nagui, Akil Mohammed, Barone Francesca, Fisher Ben, Rauz Saaeha, Richards Andrea, Bowman Simon J, UK Primary Sjögren’s Syndrome Registry
Аннотация
METHODS: We did a retrospective analysis of UKPSSR cohort data of 688 participants who had pSS with evaluable data.
RESULTS: In relation to previous/current trials, 75.2% fulfilled eligibility for the Belimumab in Subjects with Primary Sjögren's Syndrome study (Belimumab), 41.4% fulfilled eligibility for the Trial of Remicade in primary Sjögren's syndrome study (Infliximab), 35.4% for the Efficacy of Tocilizumab in Primary Sjögren's Syndrome study (Tocilizumab), 31.6% for the Tolerance and Efficacy of Rituximab in Sjögren's Disease study (Rituximab), 26.9% for the Trial of anti-B-cell therapy in pSS study (Rituximab) and 26.6% for the Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome study (Abatacept). If recent measures of outcome, such as the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score ⩾5 (measure of patient symptoms) and the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ⩾5 (measure of systemic disease activity) are incorporated into a study design, with requirements for an unstimulated salivary flow >0 and anti-Ro positivity, then the pool of eligible participants is reduced to 14.3%.
CONCLUSION: The UKPSSR identified a number of options for trial design, including selection on ESSDAI ⩾5, ESSPRI ⩾5 and serological and other parameters.