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      Tumor Necrosis Factor Inhibitor Discontinuation in Patients with Ankylosing Spondylitis: An Observational Study From the US-Based Corrona Registry

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          Abstract

          Introduction

          Tumor necrosis factor inhibitors (TNFis) have shown efficacy for the treatment of ankylosing spondylitis (AS). However, many patients may discontinue or switch TNFis due to lack of effect or adverse events. As biologics with alternative mechanisms of action become available for the treatment of AS, it is important to better understand the characteristics of patients who discontinue or have an inadequate response to TNFis to help inform treatment choices regarding initiating or switching to a biologic therapy. This study compared demographic and clinical characteristics of patients with AS who discontinued vs. continued a TNFi by their second follow-up visit in the US-based Corrona Psoriatic Arthritis and Spondyloarthritis (PsA/SpA) Registry.

          Methods

          All patients aged ≥ 18 years with AS enrolled in the Corrona PsA/SpA Registry between April 2013 and January 2015 who were receiving or had initiated a TNFi (index therapy) at the time of registry enrollment (baseline) and had ≥ 2 follow-up visits were included. Patient demographics, clinical characteristics, and patient-reported outcome scores at baseline were compared between cohorts of patients who discontinued or continued their TNFi by the second follow-up visit.

          Results

          Of the 155 included patients, 37 (23.9%) discontinued their index TNFi therapy by the second follow-up visit (mean follow-up, 17.8 months). Patients who discontinued their TNFi were older (mean age, 52.1 vs. 46.6 years; P = 0.04), were more likely to be obese (59.5% vs. 34.2%; P < 0.01), and had worse mean Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores (4.8 vs. 3.5 and 4.2 vs. 2.8, respectively; P = 0.01 for both) at baseline than those who continued their TNFi.

          Conclusions

          The results of this real-world study provide insight into the demographic and clinical characteristics of patients with AS who discontinue vs. continue TNFi therapy in US clinical practice.

          Funding

          Corrona, LLC.

          Plain Language Summary

          Plain language summary available for this article.

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          Most cited references33

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          The comparative one-year performance of anti-tumor necrosis factor alpha drugs in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: results from a longitudinal, observational, multicenter study.

          To compare the 1-year retention rates of anti-tumor necrosis factor alpha (anti-TNFalpha) medications in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) with complementary analyses of the effect on health status. Our analyses comprised 847, 172, and 249 anti-TNFalpha treatment courses in patients with RA, PsA, and AS, respectively. Crude drug survival was compared and hazard ratios (HRs) for treatment termination were calculated with adjustments for age, sex, investigator's global assessment, and concomitant methotrexate (MTX). Adjusted changes in health-related quality of life (HRQOL) were compared among the groups. Unadjusted 1-year retention rates were 65.4%, 77.3%, and 77.5% in the RA, PsA, and AS groups, respectively. The adjusted HRs for treatment termination were 0.76 (95% confidence interval [95% CI] 0.53-1.07) for PsA versus RA and 0.66 (95% CI 0.47-0.92) for AS versus RA. High baseline disease activity and female sex were significantly associated with premature treatment termination, whereas concomitant MTX was associated with better drug survival. However, the impact of MTX was apparent for RA and PsA, but not for AS in stratified analyses. The improvements in HRQOL were superior in patients with PsA and AS compared with RA. Our results suggest that survival of anti-TNFalpha treatment is superior in AS and PsA patients compared with RA patients. Larger improvements in HRQOL in patients with spondylarthritides may contribute to the differences in drug survival. Concomitant MTX was associated with better retention rates in RA and PsA patients, but not AS patients.
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            Comorbidity profiles among patients with ankylosing spondylitis: a nationwide population-based study.

            Ankylosing spondylitis (AS) is a systemic inflammatory disease that can result in chronic pain and disability. This study aimed to analyse the prevalence and risk of medical comorbidities in patients with AS compared with the general population. 11 701 patients with AS and 58 505 matching controls were selected for analysis from the National Health Insurance Research Dataset (NHIRD) in Taiwan. The Elixhauser comorbidity index was used for selecting medical comorbidities. Pearson chi2 tests and conditional logistic regression a nalyses were performed to examine the prevalence and risk of comorbidities between these two groups. Patients with AS were at increased risk for multiple systemic comorbidities including cardiovascular, neurological, pulmonary, gastrointestinal, endocrine, haematological and mental illness. The most prevalent comorbidities in patients with AS were hypertension (16.4%), peptic ulcers (13.9%) and headaches (10.2%). The results show that patients with AS have a higher prevalence of multiple comorbidities than the general population in Taiwan. These findings are consistent with previous studies done in Western populations. The results could be useful for both the clinical management of patients with AS and for researching the underlying pathological mechanisms.
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              Population-based estimates of common comorbidities and cardiovascular disease in ankylosing spondylitis.

              To study the rate of common comorbidities and cardiovascular disease in patients with ankylosing spondylitis (AS) compared with the general population seeking health care. This cohort study included 935 subjects (67% men) ages ≥20 years diagnosed with AS and the adult background population in Southern Sweden. During 2004 to 2007 we recorded the occurrence of physicians' diagnostic codes for a select number of comorbidities commonly associated with AS and cardiovascular disease and risk factors. We obtained standardized morbidity-rate ratios (SMRs) by dividing the observed morbidity rate in AS patients by the expected rate based on the corresponding rate of the disease in the general population of the county seeking health care. The highest SMRs were found for uveitis (34.35, 95% confidence interval [95% CI] 28.55-40.98) and inflammatory bowel disease (9.28, 95% CI 7.07-11.97). Also, we found increased SMRs for ischemic heart diseases (2.20, 95% CI 1.77-2.70), hypertension (1.98, 95% CI 1.72-2.28), and diabetes mellitus (1.41, 95% CI 1.10-1.78). Furthermore, the SMRs for psoriasis, osteoporosis, and atrioventricular blocks were also statistically significantly elevated. Inflammatory diseases affecting the eye and the digestive system were the most notable comorbidities in AS patients, but the rate for cardiovascular disease was also high. Using comprehensive longitudinal population-based register data is a promising tool to evaluate the excess consultation rate and total burden of rheumatic disease on patients and society. Copyright © 2011 by the American College of Rheumatology.
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                Author and article information

                Contributors
                pmease@philipmease.com
                Journal
                Rheumatol Ther
                Rheumatol Ther
                Rheumatology and Therapy
                Springer Healthcare (Cheshire )
                2198-6576
                2198-6584
                23 October 2018
                23 October 2018
                December 2018
                : 5
                : 2
                : 537-550
                Affiliations
                [1 ]ISNI 0000 0004 0463 5388, GRID grid.281044.b, Swedish Medical Center and University of Washington, ; Seattle, WA USA
                [2 ]ISNI 0000000089452978, GRID grid.10419.3d, Leiden University Medical Center, ; Leiden, The Netherlands
                [3 ]Corrona, LLC, Waltham, MA USA
                [4 ]ISNI 0000 0004 0439 2056, GRID grid.418424.f, Novartis Pharmaceuticals Corporation, ; East Hanover, NJ USA
                [5 ]ISNI 0000 0004 1936 8753, GRID grid.137628.9, NYU School of Medicine, ; New York, NY USA
                Article
                129
                10.1007/s40744-018-0129-z
                6251840
                30353387
                385ce488-5fd7-413a-a8a2-e20edd4db844
                © The Author(s) 2018
                History
                : 17 August 2018
                Funding
                Funded by: Corrona, LLC
                Funded by: FundRef http://dx.doi.org/10.13039/100008272, Novartis Pharmaceuticals Corporation;
                Categories
                Original Research
                Custom metadata
                © Springer Healthcare Ltd., part of Springer Nature 2018

                ankylosing spondylitis,biological therapy,registries,spondyloarthropathy,tumor necrosis factor inhibitors

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