Dataset Information

Characterization of Patients with Ankylosing Spondylitis Receiving Secukinumab and Reasons for Initiating Treatment: A US Physician Survey and Retrospective Medical Chart Review.

ABSTRACT:

Objectives

To characterize US patients with ankylosing spondylitis (AS) who were treated with secukinumab and to assess rheumatologist-reported reasons for prescribing treatment in clinical practice.

Methods

This descriptive analysis of data from a US retrospective medical chart review included patients aged???18 years diagnosed with AS who initiated secukinumab after 15 January 2016. Eligible rheumatologists used online forms to collect patient demographics, disease characteristics, co-morbidity profile, and treatment history prior to or on the index date, defined as the date of the first secukinumab prescription recorded in the medical chart. Information on physician-level characteristics and reasons for secukinumab prescription and dosing were also collected.

Results

Medical charts from 78 patients with AS who initiated secukinumab were reviewed by 25 rheumatologists between 7 July 2017 and 11 August 2017. Overall, 76.9% of patients were male, mean (SD) age was 39.8 (10.8) years, and 34.6% were biologic naïve. The most common reasons for secukinumab initiation among biologic-naïve and biologic-experienced patients, respectively, were efficacy/effectiveness (77.8%) and failure of other prior biologics (84.3%). Nearly all patients (94.9%) received a loading dose, including 150 mg every week (39.7%), 300 mg every week (53.8%), and other (1.3%). Overall, 73 patients (93.6%) received???1 maintenance secukinumab dose, of whom 56.2% and 43.8% received 150 mg and 300 mg, respectively, every 4 weeks.

Conclusions

In this US medical chart review of patients with AS who initiated secukinumab, approximately one-third were biologic naïve, and secukinumab efficacy/effectiveness and failure of other biologics were the most common reasons for initiating secukinumab.

SUBMITTER: Joshi R

PROVIDER: S-EPMC6423254 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

Characterization of Patients with Ankylosing Spondylitis Receiving Secukinumab and Reasons for Initiating Treatment: A US Physician Survey and Retrospective Medical Chart Review.

Joshi Reeti R Latremouille-Viau Dominick D Meiselbach Mark K MK Xie Jipan J Park Yujin Y Sunkureddi Prashanth P

Drugs - real world outcomes 20190301 1

<h4>Objectives</h4>To characterize US patients with ankylosing spondylitis (AS) who were treated with secukinumab and to assess rheumatologist-reported reasons for prescribing treatment in clinical practice.<h4>Methods</h4>This descriptive analysis of data from a US retrospective medical chart review included patients aged ≥ 18 years diagnosed with AS who initiated secukinumab after 15 January 2016. Eligible rheumatologists used online forms to collect patient demographics, disease characteristi ...[more]

PMID: 30617811

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Project description:ObjectiveTo determine the cost effectiveness of secukinumab, a fully human interleukin-17A inhibitor, for adults in the UK with active ankylosing spondylitis (AS) who have not responded adequately to previous treatment with conventional care (CC; biologic-naïve population) or previous biologic therapy (biologic-experienced population).Perspective and settingUK National Health Service (NHS).MethodsThe model was structured as a 3-month decision tree leading into a Markov model. Comparators were licensed tumour necrosis factor inhibitors (including available biosimilars) and CC in the biologic-naïve and biologic-experienced populations, respectively. Clinical parameters captured treatment response, short-term disease activity and patient functioning, as well as long-term structural disease progression. Utilities were derived from secukinumab trial data. List prices were used for all drugs. The cost year was 2017 and costs and outcomes were discounted at 3.5%.ResultsIn the biologic-naïve population, secukinumab dominated adalimumab and certolizumab pegol. Incremental cost-effectiveness ratios (ICERs) versus other comparators were either below £10,000 per quality-adjusted life-year (QALY) gained or south-west ICERs that implied cost effectiveness of secukinumab. In biologic-experienced patients, the ICER for secukinumab versus CC was £4927 per QALY gained. Treatment response rates, short-term treatment effects, long-term radiographic progression and biologic acquisition costs were key model drivers. Scenario analysis found results to be robust to changes in model structural assumptions. Probabilistic analysis identified greater uncertainty in results in the biologic-naïve population.ConclusionsEven at list price, secukinumab appears to represent a cost-effective use of NHS resources for biologic-naïve and biologic-experienced patients with active AS. Further research on long-term radiographic progression outcomes would be valuable for future cost-effectiveness analyses in AS.

Project description:ImportanceApproximately one-quarter of the global population have latent tuberculosis infection (LTBI), and tuberculosis (TB) is accountable for more than 1.5 million deaths annually. Methotrexate, cyclosporine, and tumor necrosis factor inhibitors may be associated with increased risk of TB and LTBI reactivation, although data are limited on the risks of TB with use of newer biologics.ObjectiveTo assess the association of secukinumab with reporting of active TB development, TB reactivation, and LTBI activation as an adverse event (AE) in patients with psoriasis, psoriatic arthritis, or ankylosing spondylitis.Design, setting, and participantsThis pooled cohort study pooled data from 28 clinical trials of secukinumab used in psoriasis (17 phase 3 or 3b and 2 phase 4 trials), psoriatic arthritis (5 phase 3 trials), and ankylosing spondylitis (4 phase 3 trials). A search of the Novartis Secukinumab Compound Pool Database was conducted for the 28 trials. All trial participants who had received at least 1 approved subcutaneous dose of secukinumab (150 mg or 300 mg) were included. Before randomization in these trials, patients underwent screening for TB. Patients with active TB were excluded, and patients with LTBI were treated according to local guidelines. Data were analyzed from the start of treatment in the individual studies through December 25, 2018.Main outcomes and measuresReporting of active TB or LTBI as an AE over a 5-year period using exposure-adjusted incidence rates (EAIR; incidence rates per 100 patient-years).ResultsA total of 12 319 patients were included, of whom 8819 patients had psoriasis (71.6%; 5930 men [67.2%]; mean [SD] age, of 44.9 [13.5] years), 2523 had psoriatic arthritis (20.5%; 1323 women [52.4%]; mean [SD] age, 48.8 [12.1] years), and 977 had ankylosing spondylitis (7.3%; 658 men [67.3%]; mean [SD] age, 42.3 [11.9] years). In the total population, 684 patients (5.6%) had tested positive for LTBI at screening. Over 5 years, LTBI as an AE during secukinumab treatment was reported in 13 patients (0.1% of 12 319). Of these 13 patients, 6 had a prior positive LTBI test result, and 7 were newly diagnosed as having LTBI. Four of the 7 patients had psoriasis (EAIR, 0.03; 95% CI, 0.01-0.07), 1 had psoriatic arthritis (EAIR, 0.02; 95% CI, 0.00-0.11), and 2 had ankylosing spondylitis (EAIR, 0.08; 95% CI, 0.01-0.28). No cases of active TB were reported.Conclusions and relevanceThis study found that LTBI reported as an AE after secukinumab treatment was uncommon and appeared to support the use of secukinumab in chronic systemic inflammatory conditions.

Project description:ObjectiveThere are no publications that have demonstrated economic value for ankylosing spondylitis (AS) treatments in Indonesia. Cost per responder (CPR) is a lean method of economic evaluation. We estimated CPR from Indonesia's health system perspective following AS treatment with secukinumab relative to adalimumab, golimumab, and infliximab.MethodsIn the absence of head-to-head trials, a comparative evidence analysis was conducted in the form of matching-adjusted indirect comparison (MAIC) to estimate the response rate of various competing treatment options against secukinumab. This was followed by a CPR analysis that compared the cost per patient for a defined response level.ResultsBased on MAIC, patients on secukinumab had higher Assessment in Spondyloarthritis International Society (ASAS) 20 response (improvement of ≥ 20% and ≥ 1 unit in at least three domains on a scale of 10 and no worsening of ≥ 20% and ≥ 1 unit in remaining domain on a scale of 10) and ASAS 40 response (improvement of ≥ 40% and ≥ 2 units in at least three domains on a scale of 10 and no worsening at all in remaining domain) versus those on adalimumab, golimumab, and infliximab at week 24. The cost per ASAS 20 at week 24 for secukinumab was 75% lower than adalimumab, 65% lower than golimumab, and 80% lower than infliximab. The cost per ASAS 40 at week 24 for secukinumab was 77% lower than adalimumab, 67% lower than golimumab, and 83% lower than infliximab. Secukinumab dominated adalimumab, golimumab, and infliximab at week 24 and adalimumab at week 52, by being more efficacious at lower cost. Threshold analysis revealed that substantial reduction in efficacy or increase in cost of secukinumab would make secukinumab not cost effective, indicating the robustness of the results.ConclusionThis study demonstrated that if AS patients in Indonesia were treated with secukinumab instead of comparator therapies, more patients could be treated, and more patients would reach response to treatment for the same budget.

Project description:BackgroundAlthough canakinumab has demonstrated efficacy in multiple trials in patients with periodic fever syndromes (PFS), the evidence on initiation of canakinumab among PFS patients in real world setting is not well understood. We aimed to characterize the reasons for canakinumab initiation among patients with PFS, specifically, cryopyrin-associated periodic syndrome (CAPS), hyperimmunoglobulin D syndrome/mevalonate kinase deficiency (HIDS/MKD), TNF receptor-associated periodic syndrome (TRAPS) and familial Mediterranean fever (FMF).MethodsPhysicians retrospectively reviewed the medical charts of PFS patients prescribed canakinumab between 2016 and 2018. Information collected included patient clinical characteristics, reasons for previous treatment discontinuation and canakinumab initiation. The results were summarized for overall patients, and by children (< 18 years) and adults and by subtype of PFS.ResultsFifty-eight physicians in the US (rheumatologists, 44.8 %; allergists/immunologists, 29.3 %; dermatologists, 25.9 %) abstracted information for 147 patients (children, 46.3 %; males, 57.1 %; CAPS, 36.7 %; TRAPS, 26.5 %; FMF, 26.5 %; HIDS/MKD, 6.8 %; Mixed, 3.4 %). Overall, most patients (90.5 %) received treatment directly preceding canakinumab (NSAIDs, 27.8 % [40.0 % in HIDS/MKD]; anakinra, 24.1 % [32.7 % in CAPS]; colchicine, 21.8 % [35.9 % in FMF]), which were discontinued due to lack of efficacy/effectiveness (39.5 %) and availability of a new treatment (36.1 %). The common reasons for canakinumab initiation were physician perceived efficacy/effectiveness (81.0 %; children, 75.0 %; adults, 86.1 %), lack of response to previous treatment (40.8 %; children, 38.2 %; adults, 43.0 %) and favorable safety profile/tolerability (40.1 %; children, 42.6 %; adults, 38.0 %). Within subtypes, efficacy/effectiveness was the most stated reason for canakinumab initiation in HIDS/MKD (90.9 %), lack of response to previous treatment in FMF (52.4 %) and convenience of administration/dosing in CAPS (27.1 %).ConclusionsThis study provided insights into how canakinumab is initiated in US clinical practice among PFS patients, with physician perceived efficacy/effectiveness of canakinumab, lack of response to previous treatment and favorable safety profile/tolerability of canakinumab being the dominant reasons for canakinumab initiation in all patients and in children and adults and PFS subtypes. Notably, the favorable safety profile/tolerability of canakinumab was more often the reason for initiation among children versus adults.

Dataset Information

Characterization of Patients with Ankylosing Spondylitis Receiving Secukinumab and Reasons for Initiating Treatment: A US Physician Survey and Retrospective Medical Chart Review.

Objectives

Methods

Results

Conclusions

Publications

Characterization of Patients with Ankylosing Spondylitis Receiving Secukinumab and Reasons for Initiating Treatment: A US Physician Survey and Retrospective Medical Chart Review.

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