AB1098 Patient Reported Reasons for Refraining from Participation in Dose Reduction Studies with Biologics
Authors: A. Marsman, M. l'Ami, E. Kneepkens, L. Kienhorst, M. Nurmohamed, C. Krieckaert, G. Wolbink
Journal: Annals of the Rheumatic Diseases (2015)

<h3>Background</h3> The proportion of patients with rheumatic diseases using biologics is considerable, which puts a large financial burden on our health care system. Currently, two open randomized controlled dose reduction studies are ongoing at our institute, both using a different tapering strategy. The first study (“<i>high drug level</i>”-study) concerns rheumatoid arthritis patients using adalimumab 40 mg every other week. Patients with an adalimumab trough concentration ≥8 mg/l are randomized to continuation of adalimumab or prolongation of the dosage interval to once every 3 weeks, independent of disease activity [1]. The second study (“<i>minimal disease activity (MDA)</i>”-study) concerns RA, psoriatic arthritis and ankylosing spondylitis patients using etanercept 50 mg weekly. In this study only patients meeting criteria for MDA [2,3,4,5] are randomized to continuation of etanercept or prolongation of the dosage interval to once every 2 weeks (phase 1), independent of etanercept drug level. After 6 months, patients still meeting MDA criteria, are further down-titrated to either etanercept 50 mg every two weeks (continuation group first phase) or discontinuation of etanercept (phase 2). In both studies, patients perceiving worsening of disease activity are allowed to restart either adalimumab or etanercept standard dose. <h3>Objectives</h3> To examine patient reported reasons for refraining from participation in biological dose reduction studies using different tapering strategies. <h3>Methods</h3> All patients at our institution eligible for study participation were approached. <h3>Results</h3> To date, a total of 193 adalimumab-treated patients were approached for participation in the “<i>high drug level</i>”-study as well as 236 etanercept-treated patients for “<i>MDA</i>”-study. Of these patients, respectively 61 (32%) and 132 (56%) refrained from participating for a variety of reasons (figure 1). Most common reason in both studies was anxiousness of a flare of disease activity. Noticeably, a proportion of patients already tapered outside a study context (16% in the “<i>MDA</i>”-study vs. 8% in the “<i>high drug level</i>”-study). A proportion of patients was hesitant to taper due to experiences in the past (e.g. a missed dose due to infection or vacation followed by an increase of arthralgia). <h3>Conclusions</h3> A considerable proportion of biological-treated rheumatology patients is hesitant to participate in dose reduction studies, irrespective of the tapering strategy. Possibly, there is a larger role for the treating physician to motivate patients to participate in dose reduction studies, as optimizing therapy with biologicals is an important step in the development of personalized and cost-effective treatment strategies in the future. <h3>References</h3> Pouw MF et al. ARD 2013. Wells GA et al. J Rheum 2005. Coates LC et al. ARD 2010. Van der Heijde D et al. ARD 2009. Coates LC et al. Arthritis Care Res 2010. <h3>Acknowledgements</h3> The authors are grateful to the Dutch Arthritis Association (Reumafonds) and Achmea Dutch health insurance for receiving financial support. <h3>Disclosure of Interest</h3> A. Marsman: None declared, M. l9Ami: None declared, E. Kneepkens Speakers bureau: Pfizer, L. Kienhorst: None declared, M. Nurmohamed Consultant for: Abbott, Roche, Pfizer, MSD, UCB, SOBI and BMS., Speakers bureau: Abbott, Roche and Pfizer., C. Krieckaert Speakers bureau: Pfizer, G. Wolbink Grant/research support from: Pfizer (paid to the institution), Speakers bureau: Pfizer, Amgen, Abbvie, UCB and BMS.