BackgroundBiologic 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.ObjectivesTo 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.MethodsThis 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.ResultsOf 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.ConclusionsIn 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 ...
This study aimed to assess the safety of this procedure in children, including surgical complications and survival outcome following LDLT, to evaluate the effectiveness of open donor hepatectomy versus pure laparoscopic donor hepatectomy in a high-volume LDLT center. Methods: The medical records of 107 patients (aged 17 years) who underwent ABO compatible LDLT from May 2008 to June 2016 were analyzed. Of 107 patients, 76underwent open donor hepatectomy and 31 underwent pure laparoscopic donor hepatectomy. To overcome bias from the differing distribution of co-variables among patients in the two study groups, a 1:1 propensity score matching analysis was performed using the nearest-neighbor matching method. Results: The mean follow-up period was 92.9 months in the open group and 92.7 months in the laparoscopic group. The length of post-operative hospital stay of the donor was statistically shorter in the laparoscopic group than in the open group. The overall surgical complication rate did not differ between the groups. The 1-, 3-, and 5-year overall survival rates were 93.6%, 93.6%, and 93.6% in the open group and 96.8%, 93.6% and 93.6% in the laparoscopic group, respectively. Conclusions: Laparoscopic hepatectomy may be more beneficial for the donor, and the use of laparoscopic methods on the donor does not adversely affect the recipient s outcome. Thus, laparoscopic hepatectomy is a safe, feasible, and reproducible procedure for pediatric liver transplantation.
BackgroundFor 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.ObjectivesTo 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.MethodsThis 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.ResultsOf 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.ConclusionsIn 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...
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