Background Biologic therapy used for the treatment of active psoriatic arthritis (PsA) can sometimes be augmented by adding non-biologic medications and/or escalating the dose of the biologic therapy. Limited data exist on how theses therapy modifications are used in patients with PsA receiving biologic treatment in real-world settings.
Objectives To describe therapy modifications (adding non-biologic medications or dose escalation of the current biologic therapy) in patients with PsA receiving biologic therapy in the United States.
Methods This study used US administrative claims data from the Optum Research Database. Adults with PsA who newly initiated (no evidence of use in the 12 months prior) a biologic between January 1, 2013 and January 31, 2015, and were continuously enrolled in a commercial or Medicare Advantage health plan 12 months before (baseline period) and 15 months following the index date, defined as the date of first pharmacy fill or medical infusion, were included. To reduce confounding by patients with an early switch/discontinuation, therapy modifications were identified only in those patients who persisted with their index biologic for >90 days. Therapy modifications identified included initiation of add-on medications (disease-modifying antirheumatic drugs [DMARDs], nonsteroidal anti-inflammatory drugs [NSAIDs], opioids, corticosteroids, antidepressants, anxiolytics, sleeping aids and topical analgesics) after the first 90 days of persistence, and dose escalation of the index biologic. Dose escalation was defined as a patient receiving a dose >10% above the reference dose from the product label for ≥90 days.
Results Of the 1,010 patients included who persisted on their index biologic for >90 days, 80.5% initiated a subcutaneous tumor necrosis factor inhibitor (TNFi-SC; adalimumab, certolizumab pegol, etanercept or golimumab) as their index biologic, 12.0% initiated an intravenous TNFi (TNFi-IV; infliximab) and 7.5% initiated ustekinumab. During the 12-month baseline period, patients had a mean (standard deviation) number of claims of 2.9 (4.3) for conventional synthetic DMARDs (csDMARDs), 2.6 (5.0) for opioids, 2.2 (3.1) for NSAIDs and 2.0 (2.9) for corticosteroids. Overall, 45.5% of patients received ≥1 additional medication during the period from 90 days after the index date to the end of persistence with the index biologic or immediate 12-month post-index period. The most commonly added medications were corticosteroids (22.0%), opioids (17.1%), NSAIDs (12.9%) and csDMARDs (5.3%) (Table 1). Overall, 9.6% of patients had a dose escalation of the index biologic (33.9% for TNFi-IV, 6.4% for TNFi-SC and 5.3% for ustekinumab) in the immediate 12-month post-index period.
Conclusions In this descriptive, administrative claims-based study, nearly one-half ($≈ $ 45%) of patients with PsA receiving biologic therapy initiated an add-on medication, most of which were pain medications. Further research is needed to better understand the reasons for therapy modifications during biologic treatment and the impact of insufficient control of pain in patients with PsA in the United States.
Acknowledgements This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ.
Disclosure of Interest J. Walsh Consultant for: Novartis, O. Adejoro Employee of: Optum, B. Chastek Employee of: Optum, G. Chun Employee of: Novartis, J. Palmer Employee of: Novartis