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Unmet needs in psoriatic arthritis patients receiving immunomodulatory therapy: results from a large multinational real-world study

  • Rieke AltenEmail author
  • P. G. Conaghan
  • V. Strand
  • E. Sullivan
  • S. Blackburn
  • H. Tian
  • K. Gandhi
  • S. M. Jugl
  • A. Deodhar
Original Article
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Abstract

Objective

There are limited data on therapy selection and switching in psoriatic arthritis (PsA). This 18 country, real-world study assessed use and switching of immunomodulatory therapy (biologic/apremilast), the extent of treatment failure and its association with reduced physical functioning, health-related quality of life (HRQoL), and work productivity and activity impairment (WPAI).

Methods

PsA patients under routine care and their treating physicians provided demographics, current therapy, reasons for switching, duration of first therapy, HRQoL, HAQ-DI, and WPAI. Current immunomodulatory therapy was determined as “failing” if, after ≥ 3 months, physician-rated disease severity had worsened, remained severe, was “unstable/deteriorating,” or they were dissatisfied with disease control and/or did not consider treatment a “success.”

Results

Included were 3714 PsA patients; 1455 (40.6%) had never received immunomodulatory therapy; 1796 (50.1%) had ever received 1 immunomodulatory therapy and 331 (9.2%) ≥ 1. Lack of efficacy with first immunomodulatory therapy was the most common reason for switching; patients whose physicians indicated “primary lack of efficacy” as the reason, switched after a mean of 9.4 months. Patients currently failing immunomodulator therapies (n = 246) had poorer HRQoL compared with treatment success (n = 1472) measured by EQ-5D-3L (0.60 vs 0.77%; P < 0.0001); SF-36 PCS (40.8% vs 46.1%; P < 0.0001) MCS (41.1% vs 45.3%; P < 0.0001). Physical functioning, activity, and work productivity were also more impaired (HAQ-DI: 0.88 vs 0.56; activity impairment: 46.7% vs 29.7%; overall work impairment: 35.4% vs 26.1%; all P < 0.0001).

Conclusions

Poor treatment response in PsA is associated with substantial negative patient impact. In cases of primary treatment failure, timely switching is needed.

Keywords

Health-related quality of life Psoriatic arthritis TNFi Treatment Work 

Notes

Acknowledgments

PGC is supported in part by the UK NIHR Leeds Biomedical Research Centre. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. The authors and Novartis would like to thank all patients and physicians who participated in this study.

Funding information

This study was supported by Novartis Pharma AG, Switzerland. Medical writing support was provided by Kate Revill of Adelphi Real World Ltd., funded by Novartis Pharma AG.

Compliance with ethical standards

Conflict of interest

RA has received grants or research support from Bristol-Myers Squibb, consulting fees from Bristol-Myers Squibb, Novartis, Pfizer Roche, and Eli Lilly. PGC has received speakers’ bureau or consulting fees from Bristol- Myers Squibb, Pfizer, and Novartis. VS has received grants and/or consulting fees from AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, Corrona LLC, Crescendo Bioscience, EMD Serono, F. Hoffmann-La Roche Ltd./Genentech, Inc., GSK, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, and UCB and has served on advisory boards for AbbVie, Amgen, AstraZeneca, BMS, Celltrion, Crescendo/Myriad Genetics, EMDSerono, Genentech/Roche, GSK, Janssen, Lilly, Novartis, Pfizer, Regeneron, Sandoz, Sanofi, and UCB. AD has received grants or research support from AbbVie, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer, and UCB Pharma, and consulting fees from Eli Lilly, Janssen, Novartis, Pfizer, and UCB Pharma. ES and SB are employees of Adelphi Real World; HT and KG are shareholders and employees of Novartis; SJ is a shareholder and employee of Novartis Pharma AG.

Supplementary material

10067_2019_4446_Fig4_ESM.png (45 kb)
Supplementary Fig. 1

Reasons for switching from first to second TNFi (n = 304). Physician-reported reasons given for patient switching from first- to second-line immunomodulator therapy. *Secondary lack of efficacy (loss of response over time); ‡ I wanted to use a bDMARD that can be used in combination; † I wanted to use bDMARD that can be used as a monotherapy. bDMARD: biologic disease modifying anti-rheumatic drugs; MOA, mode of action (PNG 44 kb)

10067_2019_4446_MOESM1_ESM.tif (128 kb)
High-resolution image (TIF 128 kb)

References

  1. 1.
    Liu JT, Yeh HM, Liu SY, Chen KT (2014) Psoriatic arthritis: epidemiology, diagnosis, and treatment. World J Orthop 5(4):537–543.  https://doi.org/10.5312/wjo.v5.i4.537 CrossRefGoogle Scholar
  2. 2.
    Lloyd P, Ryan C, Menter A (2012) Psoriatic arthritis: an update. Arthritis 2012:176298.  https://doi.org/10.1155/2012/176298 CrossRefGoogle Scholar
  3. 3.
    Reveille JD, Witter JP, Weisman MH (2012) Prevalence of axial spondylarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care Res (Hoboken) 64(6):905–910.  https://doi.org/10.1002/acr.21621 CrossRefGoogle Scholar
  4. 4.
    Hukuda S, Minami M, Saito T, Mitsui H, Matsui N, Komatsubara Y, Makino H, Shibata T, Shingu M, Sakou T, Shichikawa K (2001) Spondyloarthropathies in Japan: nationwide questionnaire survey performed by the Japan Ankylosing Spondylitis Society. J Rheumatol 28(3):554–559Google Scholar
  5. 5.
    Salaffi F, Carotti M, Gasparini S, Intorcia M, Grassi W (2009) The health-related quality of life in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis: a comparison with a selected sample of healthy people. Health Qual Life Outcomes 7:25.  https://doi.org/10.1186/1477-7525-7-25 CrossRefGoogle Scholar
  6. 6.
    Gossec L, Smolen JS, Gaujoux-Viala C, Ash Z, Marzo-Ortega H, van der Heijde D, FitzGerald O, Aletaha D, Balint P, Boumpas D, Braun J, Breedveld FC, Burmester G, Canete JD, de Wit M, Dagfinrud H, de Vlam K, Dougados M, Helliwell P, Kavanaugh A, Kvien TK, Landewe R, Luger T, Maccarone M, McGonagle D, McHugh N, McInnes IB, Ritchlin C, Sieper J, Tak PP, Valesini G, Vencovsky J, Winthrop KL, Zink A, Emery P, European League Against R (2012) European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis 71(1):4–12.  https://doi.org/10.1136/annrheumdis-2011-200350 CrossRefGoogle Scholar
  7. 7.
    Zerilli T, Ocheretyaner E (2015) Apremilast (Otezla): a new oral treatment for adults with psoriasis and psoriatic arthritis. P T 40(8):495–500Google Scholar
  8. 8.
    Mease P, McInnes IB (2016) Secukinumab: a new treatment option for psoriatic arthritis. Rheumatol Ther 3(1):5–29.  https://doi.org/10.1007/s40744-016-0031-5 CrossRefGoogle Scholar
  9. 9.
    Nash P, Kirkham B, Okada M, Rahman P, Combe B, Burmester GR, Adams DH, Kerr L, Lee C, Shuler CL, Genovese M, Group S-PS (2017) Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet 389(10086):2317–2327.  https://doi.org/10.1016/S0140-6736(17)31429-0 CrossRefGoogle Scholar
  10. 10.
    Gladman D, Rigby W, Azevedo VF, Behrens F, Blanco R, Kaszuba A, Kudlacz E, Wang C, Menon S, Hendrikx T, Kanik KS (2017) Tofacitinib for psoriatic arthritis in patients with an inadequate response to TNF inhibitors. N Engl J Med 377(16):1525–1536.  https://doi.org/10.1056/NEJMoa1615977 CrossRefGoogle Scholar
  11. 11.
    Mease PJ, Gottlieb AB, van der Heijde D, FitzGerald O, Johnsen A, Nys M, Banerjee S, Gladman DD (2017) Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis 76(9):1550–1558.  https://doi.org/10.1136/annrheumdis-2016-210724 CrossRefGoogle Scholar
  12. 12.
    ACR and NPF Unveil New Clinical Guideline for Treating Psoriatic Arthritis. (2017) AMJC. http://www.ajmc.com/conferences/acr-2017/acr-and-npf-unveil-new-clinical-guideline-for-treating-psoriatic-arthritis. Accessed February 12 2018
  13. 13.
    Coates LC, Murphy R, Helliwell PS (2016) New GRAPPA recommendations for the management of psoriasis and psoriatic arthritis: process, challenges and implementation. Br J Dermatol 174(6):1174–1178.  https://doi.org/10.1111/bjd.14667 CrossRefGoogle Scholar
  14. 14.
    Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, Emery P, Landewe R, Oliver S, Aletaha D, Betteridge N, Braun J, Burmester G, Canete JD, Damjanov N, FitzGerald O, Haglund E, Helliwell P, Kvien TK, Lories R, Luger T, Maccarone M, Marzo-Ortega H, McGonagle D, McInnes IB, Olivieri I, Pavelka K, Schett G, Sieper J, van den Bosch F, Veale DJ, Wollenhaupt J, Zink A, van der Heijde D (2016) European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis 75(3):499–510.  https://doi.org/10.1136/annrheumdis-2015-208337 CrossRefGoogle Scholar
  15. 15.
    Anderson P, Benford M, Harris N, Karavali M, Piercy J (2008) Real-world physician and patient behaviour across countries: disease-specific programmes - a means to understand. Curr Med Res Opin 24(11):3063–3072.  https://doi.org/10.1185/03007990802457040 CrossRefGoogle Scholar
  16. 16.
    Services UDoHaH (2003) Summary of the HIPAA privacy rule. http://www.hhs.gov/sites/default/files/privacysummary.pdf. Accessed May 11th 2017
  17. 17.
    Technology HI Health Information Technology Act. https://www.healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf. Accessed 11 May 2017
  18. 18.
    Association EPMR (2017) European Pharmaceutical Market Research Association (EphMRA) code of conduct http://www.ephmra.org/Code-of-Conduct-Support. Accessed 11 May 2017
  19. 19.
    Fries JF, Spitz PW, Young DY (1982) The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol 9(5):789–793Google Scholar
  20. 20.
    EuroQol G (1990) EuroQol–a new facility for the measurement of health-related quality of life. Health Policy 16(3):199–208CrossRefGoogle Scholar
  21. 21.
    Ware JE Jr, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I Conceptual framework and item selection. Med Care 30(6):473–483CrossRefGoogle Scholar
  22. 22.
    Reilly MC, Zbrozek AS, Dukes EM (1993) The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 4(5):353–365CrossRefGoogle Scholar
  23. 23.
    Lie E, van der Heijde D, Uhlig T, Mikkelsen K, Rodevand E, Koldingsnes W, Kaufmann C, Kvien TK (2011) Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register. Ann Rheum Dis 70(1):157–163.  https://doi.org/10.1136/ard.2010.131797 CrossRefGoogle Scholar
  24. 24.
    Plasencia C, Pascual-Salcedo D, Garcia-Carazo S, Lojo L, Nuno L, Villalba A, Peiteado D, Arribas F, Diez J, Lopez-Casla MT, Martin-Mola E, Balsa A (2013) The immunogenicity to the first anti-TNF therapy determines the outcome of switching to a second anti-TNF therapy in spondyloarthritis patients. Arthritis Res Ther 15(4):R79.  https://doi.org/10.1186/ar4258 CrossRefGoogle Scholar
  25. 25.
    Walsh JA, Adejoro O, Chastek B, Palmer JB, Hur P (2018) Treatment patterns among patients with psoriatic arthritis treated with a biologic in the United States: descriptive analyses from an administrative claims database. J Manag Care Spec Pharm:1–11.  https://doi.org/10.18553/jmcp.2018.17388
  26. 26.
    Davis K (2002) The Danish health system through an American lens. Health Policy 59(2):119–132CrossRefGoogle Scholar
  27. 27.
    StataCorp (2015) Stata statistical software: release 14. College Station, TX: StataCorp LP. https://www.stata.com/support/faqs/resources/citing-software-documentation-faqs/
  28. 28.
    Reddy SM, Crean S, Martin AL, Burns MD, Palmer JB (2016) Real-world effectiveness of anti-TNF switching in psoriatic arthritis: a systematic review of the literature. Clin Rheumatol 35(12):2955–2966.  https://doi.org/10.1007/s10067-016-3425-4 CrossRefGoogle Scholar
  29. 29.
    Glintborg B, Ostergaard M, Krogh NS, Andersen MD, Tarp U, Loft AG, Lindegaard HM, Holland-Fischer M, Nordin H, Jensen DV, Olsen CH, Hetland ML (2013) Clinical response, drug survival, and predictors thereof among 548 patients with psoriatic arthritis who switched tumor necrosis factor alpha inhibitor therapy: results from the Danish Nationwide DANBIO registry. Arthritis Rheum 65(5):1213–1223.  https://doi.org/10.1002/art.37876 CrossRefGoogle Scholar
  30. 30.
    Fagerli KM, Lie E, van der Heijde D, Heiberg MS, Kalstad S, Rodevand E, Mikkelsen K, Lexberg AS, Kvien TK (2013) Switching between TNF inhibitors in psoriatic arthritis: data from the NOR-DMARD study. Ann Rheum Dis 72(11):1840–1844.  https://doi.org/10.1136/annrheumdis-2012-203018 CrossRefGoogle Scholar
  31. 31.
    Coates LC, Cawkwell LS, Ng NW, Bennett AN, Bryer DJ, Fraser AD, Emery P, Marzo-Ortega H (2008) Sustained response to long-term biologics and switching in psoriatic arthritis: results from real life experience. Ann Rheum Dis 67(5):717–719.  https://doi.org/10.1136/ard.2007.082925 CrossRefGoogle Scholar
  32. 32.
    Merola JF, Lockshin B, Mody EA (2017) Switching biologics in the treatment of psoriatic arthritis. Semin Arthritis Rheum.  https://doi.org/10.1016/j.semarthrit.2017.02.001
  33. 33.
    Edwards CJ, Blanco FJ, Crowley J, Birbara CA, Jaworski J, Aelion J, Stevens RM, Vessey A, Zhan X, Bird P (2016) Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3). Ann Rheum Dis 75(6):1065–1073.  https://doi.org/10.1136/annrheumdis-2015-207963 CrossRefGoogle Scholar
  34. 34.
    Kawalec P, Holko P, Mocko P, Pilc A (2018) Comparative effectiveness of abatacept, apremilast, secukinumab and ustekinumab treatment of psoriatic arthritis: a systematic review and network meta-analysis. Rheumatol Int 38(2):189–201.  https://doi.org/10.1007/s00296-017-3919-7 CrossRefGoogle Scholar
  35. 35.
    Husted JA, Gladman DD, Farewell VT, Cook RJ (2001) Health-related quality of life of patients with psoriatic arthritis: a comparison with patients with rheumatoid arthritis. Arthritis Rheum 45(2):151–158.  https://doi.org/10.1002/1529-0131(200104)45:2<151::AID-ANR168>3.0.CO;2-T CrossRefGoogle Scholar
  36. 36.
    Armstrong AW, Schupp C, Wu J, Bebo B (2012) Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003–2011. PLoS One 7(12):e52935.  https://doi.org/10.1371/journal.pone.0052935 CrossRefGoogle Scholar
  37. 37.
    Helliwell P, Coates L, Chandran V, Gladman D, de Wit M, FitzGerald O, Kavanaugh A, Strand V, Mease PJ, Boehncke WH, Langley RG, Lubrano E, Maccarone M, Schulze-Koops H, Miceli-Richard C, Queiro R (2014) Qualifying unmet needs and improving standards of care in psoriatic arthritis. Arthritis Care Res (Hoboken) 66(12):1759–1766.  https://doi.org/10.1002/acr.22404 CrossRefGoogle Scholar
  38. 38.
    Strand V, Mease P, Gossec L, Elkayam O, van den Bosch F, Zuazo J, Pricop L, Mpofu S, Group Fs (2017) Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1). Ann Rheum Dis 76(1):203–207.  https://doi.org/10.1136/annrheumdis-2015-209055 CrossRefGoogle Scholar
  39. 39.
    Strand V, Schett G, Hu C, Stevens RM (2013) Patient-reported health-related quality of life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study. J Rheumatol 40(7):1158–1165.  https://doi.org/10.3899/jrheum.121200 CrossRefGoogle Scholar
  40. 40.
    Strand V, Sharp V, Koenig AS, Park G, Shi Y, Wang B, Zack DJ, Fiorentino D (2012) Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment. Ann Rheum Dis 71(7):1143–1150.  https://doi.org/10.1136/annrheumdis-2011-200387 CrossRefGoogle Scholar
  41. 41.
    Kennedy M, Papneja A, Thavaneswaran A, Chandran V, Gladman DD (2014) Prevalence and predictors of reduced work productivity in patients with psoriatic arthritis. Clin Exp Rheumatol 32(3):342–348Google Scholar
  42. 42.
    Tillett W, Shaddick G, Askari A, Cooper A, Creamer P, Clunie G, Helliwell PS, Kay L, Korendowych E, Lane S, Packham J, Shaban R, Williamson L, McHugh N (2015) Factors influencing work disability in psoriatic arthritis: first results from a large UK multicentre study. Rheumatology (Oxford) 54(1):157–162.  https://doi.org/10.1093/rheumatology/keu264 CrossRefGoogle Scholar
  43. 43.
    Walsh JA, McFadden ML, Morgan MD, Sawitzke AD, Duffin KC, Krueger GG, Clegg DO (2014) Work productivity loss and fatigue in psoriatic arthritis. J Rheumatol 41(8):1670–1674.  https://doi.org/10.3899/jrheum.140259 CrossRefGoogle Scholar

Copyright information

© International League of Associations for Rheumatology (ILAR) 2019

Authors and Affiliations

  • Rieke Alten
    • 1
    Email author
  • P. G. Conaghan
    • 2
  • V. Strand
    • 3
  • E. Sullivan
    • 4
  • S. Blackburn
    • 4
  • H. Tian
    • 5
  • K. Gandhi
    • 5
  • S. M. Jugl
    • 6
  • A. Deodhar
    • 7
  1. 1.Internal Medicine II, Rheumatology bei Schlosspark-KlinikUniversity MedicineBerlinGermany
  2. 2.Leeds Institute of Rheumatic and Musculoskeletal MedicineUniversity of Leeds & NIHR Leeds Biomedical Research CentreLeedsUK
  3. 3.Stanford UniversityPalo AltoUSA
  4. 4.Adelphi Real WorldManchesterUK
  5. 5.Novartis Pharmaceuticals CorporationEast HanoverUSA
  6. 6.Novartis Pharma AGBaselSwitzerland
  7. 7.Oregon Health & Science UniversityPortlandUSA

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