PracticeUpdate Conference Series - ANZAN 2018

" …loop recorders provide good value for the money in the Australian context. They identify patients who need anticoagulation to prevent recurrent stroke. We hope clinicians adopt this strategy to help reduce the burden of stroke in Australia. "

initiating oral anticoagulation after crypto- genic stroke. Paroxysmal atrial fibrillation can be difficult to diagnose, however, with short-term cardiac monitoring. Dr. Thijs and colleagues set out todetermine whether long-term continuous monitoring with an insertable cardiac monitor is cost-ef- fective for preventing recurrent stroke in patients with cryptogenic stroke. Dr. Thijs told Elsevier’s PracticeUpdate , “Whether loop recorders provide good value for money when used to detect atrial fibrillation after unexplained ischemic stroke has been questioned. We therefore modeled the trajectory of patients after such a stroke and counted both costs and how much quality adjusted life years changed when such a device was used.” A lifetime Markov model was developed to simulate patient follow-up. Long-term continuous monitoring with an insertable cardiac monitor was compared with con- ventional monitoring. A linked evidence approach was used to estimate rates of recurrent stroke when atrial fibrillation detection led to initiation of oral anticoagulation, as detected using the insertable cardiac monitor during the lifetime of the device vs detection during usual care. The safety profile in newly diagnosed patients was similar to that of the overall patient population. Dr. Newsome concluded that, consistent with results of the ADVANCE trial, newly diagnosed, treatment-naive patients with RRMS experienced significantly reduced disease activity when administered pegin- terferon ß-1a every 2 weeks vs patients whose treatment was delayed. The results were consistent with those of the overall ADVANCE population and highlighted the benefits of initiating ther- apy early in the disease course of RRMS. Marco Salvetti, MD, of Sapienza University, S. Andrea Hospital in Rome, Italy, and col- leagues set out to delineate the baseline characteristics and safety profile of patients with RRMS in the first interim analysis of peginterferon ß-1a treatment in the phase IV Plegridy Observational Program. Dr. Salvetti explained that the 5-year, observational, phase IV Plegridy Observational Program study explores the long-term safety and effectiveness of peginterferon ß-1a 125 µg every 2

Diagnostic and patient management costs were modeled. Other model inputs were determined by literature review. Probabilistic sensitivity analysis was undertaken to explore the effect of parameter uncertainty according to the Congestive heart failure; Hypertension; Age ≥75 years; Diabetes mellitus; prior Stroke, TIA, or thromboembolism (CHADS 2 ) score; and oral anticoagulation treatment effect. In the base-case analysis, the model pre- dicted an incremental cost-effectiveness ratio of $29,570 AUD per quality-adjusted life year. Among CHADS 2 subgroup anal- yses, the incremental cost-effectiveness ratio ranged from $26,342 AUD per quality-adjusted life year (CHADS 2 = 6) to $42,967 AUD per quality-adjusted life year (CHADS 2 = 2). weeks in patients with RRMS treated in real-world settings. He presented interim data from the Plegridy Observational Program study in terms of baseline characteristics, adverse events, and clinical effectiveness. The Plegridy Observational Program study is ongoing in >150 sites in 14 countries. Patients who initiated peginterferon ß-1a treatment either ≤31 days prior to enrol- ment (naive subgroup) or >31 days prior to enrolment (experienced subgroup) will be followed for ≤5 years. At the time of the analysis, 467 patients were included, 411 (88%) of whom were followed for ≥12 months. A total of 153 patients (33%) discontinued treatment, primarily due to adverse events (55%) or lack of efficacy (13%). At baseline, mean patient age was 44.9 years, 76% of patients were female, and mean EDSS score was 1.9. Of the 371 patients (79%) who had received prior dis- ease-modifying therapy, 217 (58%) hadbeen treated with intramuscular interferon ß-1a. More patients were naive than experi- enced (60% vs 40%). Adverse events

Probabilistic sensitivity analysis sug- gested that the probabilities of a strategy employing an insertable cardiac monitor being cost-effective were 53.4% and 78.7% at thresholds of $30,000 AUD (highly cost-effective) and $50,000 AUD per quality-adjusted life year (cost-effec- tive), respectively. Dr. Thijs concluded that long-term contin- uous monitoring with an insertable cardiac monitor is cost-effective in preventing recurrent stroke in patients following cryp- togenic stroke in the Australian context. “The results demonstrated,” he said, “that loop recorders provide good value for the money in the Australian context. They identify patients who need anticoagulation to prevent recurrent stroke. We hope cli- nicians adopt this strategy to help reduce the burden of stroke in Australia.” were more common in naive than in experienced patients (35% vs 20%), as were adverse events leading to treatment discontinuation (29% vs 15%). The most commonly reported adverse events leading to treatment discontinu- ation in both groups were injection-site erythema and influenza-like illness. Serious adverse events were reported in 5% of naive and 9% of experienced patients. A high proportion of patients in both groups were relapse-free (naive 84.4%; experienced 81.5%). Dr. Salvetti concluded that in this first interim analysis of the Plegridy Observational Program study, the safety profile was consistent with that observed in the phase III trial of peginterferon ß-1a. No new safety signals were observed. Naive patients were more likely than experienced patients to experience adverse events and to discontinue treat- ment due to injection-site reactions and flulike symptoms. Prophylactic strategies to mitigate these adverse events are needed. www.practiceupdate.com/c/68172

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13 ANZAN 2018 • PRACTICEUPDATE CONFERENCE SERIES