Background For patients with active ankylosing spondylitis (AS), biologic therapy has been shown to be an effective treatment option. Physicians treating patients with biologic therapy may modify the treatment by adding non-biologic medications and/or escalating the dose of the biologic; however, limited data exist on how these therapy modifications are used in patients with AS receiving biologic treatment in real-world settings.
Objectives To describe therapy modifications (adding non-biologic medications or dose escalation of the biologic therapy) in patients with active AS who newly initiated treatment with biologic therapy in the United States.
Methods This study used US administrative pharmacy and medical claims data from the Optum Research Database. Adult patients with AS 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 who persisted on the index biologic for >90 days. Therapy modifications identified included initiation of add-on medications (disease-modifying antirheumatic drugs, 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 333 patients with AS included who persisted on their index biologic for >90 days, 88.3% initiated a subcutaneous tumor necrosis factor inhibitor (TNFi-SC; adalimumab, certolizumab pegol, etanercept or golimumab) as their index biologic and 11.7% initiated an intravenous TNFi (TNFi-IV; infliximab). During the 12-month baseline period, patients had a mean (standard deviation) number of claims of 3.9 (6.6) for opioids, followed by 2.5 (3.1) for NSAIDs, 1.9 (2.8) for corticosteroids and 1.8 (3.7) for antidepressants. Overall, 44.7% 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 12-month post-index period. The most commonly added medications were corticosteroids (16.8%), opioids (12.9%), NSAIDs (10.2%) and antidepressants (7.2%) (Table 1). Overall, 7.2% of patients had a dose escalation of the index biologic (38.5% for TNFi-IV and 2.7% for TNFi-SC) in the immediate 12-month post-index period.
Conclusions In this descriptive, administrative claims-based study from the US, approximately 45% of patients with AS initiated an add-on medication while receiving biologic therapy. Further research is needed to better understand optimal therapy strategies for patients with AS.
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, Y. Park Employee of: Novartis