Unmet needs in ankylosing spondylitis patients receiving tumour necrosis factor inhibitor therapy; results from a large multinational real-world study

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Abstract

Background

Symptoms and comorbidities of ankylosing spondylitis (AS) considerably reduce health-related quality of life (HRQoL) and ability to work. This real-world study assessed rates of tumour necrosis factor inhibitor (TNFi) use and switching, treatment failure, and associations between failing TNFi and HRQoL, work productivity and activity impairment (WPAI).

Methods

AS patients and their treating physicians completed questionnaires capturing patient demographics, clinical status, TNFi treatment history, reasons for switching TNFi, HRQoL and WPAI. Current TNFi was determined as “failing” if, after ≥3 months, physician-rated disease severity had worsened, remained severe, was “unstable/deteriorating”, physicians were dissatisfied with disease control and/or did not consider treatment a “success”.

Results

The analysis included 2866 AS patients from 18 countries. Of 2795 patients with complete treatment data, 916 (32.8%) patients had never received TNFi therapy, 1623 (58.1%) patients were receiving their 1st TNFi and 200 (7.2%) patients had ever received ≥2 TNFi (treatment switch). Primary or secondary lack of efficacy were the commonest reasons for switching, and the mean delay in switching after primary lack of efficacy was 11.1 months. 232 (15.4%) patients on TNFi were currently “failing” who, compared to those with treatment success, reported poorer HRQoL: 5-dimension EuroQoL (EQ-5D-3 L): 0.63 vs. 0.78; Medical Outcomes Study Short-Form Health Survey version 2 (SF-36v2) mental component summary (MCS): 41.8 vs. 46.3; physical component summary (PCS): 40.2 vs. 45.1; impaired work productivity: 46.4% vs. 25.0%; and activity: 44.5% vs. 29.6%; all P < 0.001.

Conclusions

Among AS patients, switching TNFi is uncommon and delayed by nearly 1 year despite primary lack of efficacy. Patients currently failing TNFi experience worse physical function, HRQoL and work productivity.

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Most cited references 13

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Real-world physician and patient behaviour across countries: Disease-Specific Programmes - a means to understand.

P. Anderson, M Benford, N. Harris … (2008)

Treatment guidelines and strategies are often based on data from randomized controlled trials and observational clinical studies. These sources drive treatment decisions, yet the data they provide may have limited relevance to the wider population in real-world clinical practice due to the narrow selection criteria applied to patients in trials. Information used to inform clinical practice and improve patient outcomes can, therefore, be unreflective of real-world clinical situations. The purpose of this article is to assess the value of Adelphi Disease Specific Programmes (DSPs) as sources of real world data. DSPs are large, multinational, observational studies of clinical practice for a range of common chronic diseases. Treatment practice data are collected by physicians (n = 700) who are asked to provide information for the next 10 patients consulting for a specific condition. These patients (n = 7000) are also invited to fill out a self-completion form providing their own assessment of symptoms, expectations and quality of life. This article provides examples of the statistical techniques that have been employed to analyse the data in terms of cost/burden of illness, quality of life, disease severity and progression, compliance and adherence to therapy, impact of treatment guidelines and analyses of unmet need. DSPs can support clinical understanding of how diseases are managed including rationale for doctor decision-making and patient attitudes to their condition. Comparisons with other data sources and limitations of the programmes are discussed (including the fact that, unlike claims databases and registries, the DSPs are cross-sectional and not longitudinal).

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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.

Marte Schrumpf Heiberg, Wenche Koldingsnes, Knut Mikkelsen … (2008)

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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Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register.

E Lie, D van der Heijde, T. Uhlig … (2010)

To assess the effectiveness of switching to a second tumour necrosis factor inhibitor (TNFi) in patients with ankylosing spondylitis (AS). Data were extracted from an ongoing longitudinal observational multicentre study in Norway. This study included anti-TNF naïve patients with AS starting treatment with a TNFi as well as treatment with a second TNFi in these same patients. Effectiveness data and 2-year drug survival were compared between switchers and non-switchers and within switchers (first and second TNFi). 514 anti-TNF naïve patients with AS were included; 77 patients switched to a second TNFi while 437 patients did not switch. The percentages of non-switchers using etanercept, infliximab or adalimumab were 53%, 32% and 15%, and the percentages of first and second TNFi in the switchers were 42%, 53% and 5% and 40%, 23% and 36%, respectively. The reason for switching was insufficient response (IR) in 30, adverse events (AEs) in 44 and not reported in 3 patients. Baseline disease activity was similar between the groups. Three-month BASDAI 50 and ASAS 40 responses were achieved by 49% and 38% of non-switchers, by 25% and 30% of switchers after the first TNFi and by 28% and 31% after the second TNFi. The 3-month disease activity level was higher for switchers on the second TNFi than for non-switchers. Drug withdrawal rate was higher during the second TNFi among switchers than for non-switchers (p=0.001). No difference was found in the effectiveness of the second TNFi between switchers due to IR and AE. This study confirms that switching to a second TNFi can be effective in AS and can be as useful as in rheumatoid arthritis, although overall effectiveness seems to be somewhat lower than in non-switchers.

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Author and article information

Contributors

A. Deodhar: deodhara@ohsu.edu

V. Strand: vibekestrand@me.com

P. G. Conaghan: P.Conaghan@leeds.ac.uk

E. Sullivan: emma.sullivan@adelphivalues.com

S. Blackburn: s.blackburn1993@gmail.com

H. Tian: haijun.tian@novartis.com

K. Gandhi: kunal.gandhi@novartis.com

S. M. Jugl: steffen.jugl@novartis.com

R. Alten: Rieke.Alten@schlosspark-klinik.de

Journal

Journal ID (nlm-ta): BMC Rheumatol

Journal ID (iso-abbrev): BMC Rheumatol

Title: BMC Rheumatology

Publisher: BioMed Central (London )

ISSN (Electronic): 2520-1026

Publication date (Electronic): 2 March 2020

Publication date PMC-release: 2 March 2020

Publication date Collection: 2020

Volume: 4

Electronic Location Identifier: 19

Affiliations

[1 ]GRID grid.5288.7, ISNI 0000 0000 9758 5690, Oregon Health and Science University, ; Portland, OR USA

[2 ]Biopharmaceutical Consultant, Portola Valley, CA USA

[3 ]GRID grid.9909.9, ISNI 0000 0004 1936 8403, Leeds Institute of Rheumatic and Musculoskeletal Medicine, , University of Leeds & NIHR Leeds Biomedical Research Centre, ; Leeds, UK

[4 ]Adelphi Real World, Bollington, UK

[5 ]GRID grid.418424.f, ISNI 0000 0004 0439 2056, Novartis Pharmaceuticals Corporation, ; East Hanover, NJ USA

[6 ]GRID grid.419481.1, ISNI 0000 0001 1515 9979, Novartis Pharma AG, ; Basel, Switzerland

[7 ]GRID grid.6363.0, ISNI 0000 0001 2218 4662, Schlosspark-Klinik, , University Medicine, ; Berlin, Germany

Article

Publisher ID: 118

DOI: 10.1186/s41927-020-0118-z

PMC ID: 7050131

PubMed ID: 32159075

SO-VID: ff5c9584-6d18-41ce-97b5-b7ac00a730e0

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 29 January 2020

Date accepted : 5 February 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100008272, Novartis Pharmaceuticals Corporation;

Award ID: n/a

Custom metadata

Keywords: ankylosing spondylitis,dmard,quality of life,tumour necrosis factor-alpha,treatment failure

Data availability:

Keywords: ankylosing spondylitis, dmard, quality of life, tumour necrosis factor-alpha, treatment failure

Unmet needs in ankylosing spondylitis patients receiving tumour necrosis factor inhibitor therapy; results from a large multinational real-world study

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Abstract

Background

Methods

Results

Conclusions

Related collections

Asian Journal of Quality of Life (AjQoL)

Most cited references 13

Real-world physician and patient behaviour across countries: Disease-Specific Programmes - a means to understand.

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.

Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register.

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