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Drug survival and effectiveness of ustekinumab in patients with psoriatic arthritis. Real-life data from the biologic Apulian registry (BIOPURE)

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A Correction to this article was published on 21 February 2018

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Abstract

This study aims to evaluate the drug survival and effectiveness of ustekinumab in psoriatic arthritis (PsA) patients naïve to biologics or inadequate responders to tumor necrosis factor (TNF-IR) inhibitors in real life. PsA patients starting ustekinumab were enrolled from 2014 to 2016. Joint involvement, peripheral or axial, Psoriatic Area Severity Index, Disease Activity Psoriatic Arthritis (DAPSA), Lee Enthesitis Index, Health Assessment Questionnaire, body mass index, comorbidities, co-therapies, mechanism of action, and causes of discontinuation of prior TNFi were collected at baseline, and 6 and 12 months. Twelve-month drug survival was evaluated by Kaplan–Meier curves. Hazard ratios (HRs) of drug discontinuation adjusted for baseline factors were estimated by multiple Cox regression analysis. Percentages of DAPSA-based remission, as crude value and adjusted for drug retention (LUNDEX index), were compared by χ2 test. Mean differences of DAPSA from baseline to 6 and 12 months were compared between naïve and TNF-IR patients by ANOVA. Of 160 PsA patients starting ustekinumab, 54 were naïve and 106 were TNF-IR. Twelve-month drug survival was significantly higher in naïve (87%) than in TNF-IR (68%, p = 0.01). Baseline co-therapy with methotrexate did not increase the persistence on ustekinumab. Naïve patients had the lowest risk of ustekinumab discontinuation (HR 0.27, p = 0.01), and the highest DAPSA-based remission (34%, LUNDEX 26%). Mean differences from baseline of DAPSA was significantly greater in naïve than in TNF-IR patients at 12 months (− 14.4 ± 10 vs. − 4.1 ± 17, p = 0.01). Our data showed that ustekinumab has a good effectiveness in real life and the best outcomes are achieved in biologic-naïve PsA patients.

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  • 21 February 2018

    In Fig. 1 - paned D, incorrect image was published. This is now presented correctly in this article.

References

  1. Iannone F, Lopriore S, Bucci R, Lopalco G, Chialà A, Cantarini L, Lapadula G (2016) Long-term clinical outcomes in 420 patients with psoriatic arthritis taking anti-tumor necrosis factor drugs in real-world settings. J Rheumatol 43:911–917

    Article  PubMed  Google Scholar 

  2. Mease PJ (2015) Inhibition of interleukin-17, interleukin-23 and the TH17 cell pathway in the treatment of psoriatic arthritis and psoriasis. Curr Opin Rheumatol 27(2):127–133. https://doi.org/10.1097/BOR.0000000000000147

    Article  CAS  PubMed  Google Scholar 

  3. Cuchacovich RS, Espinoza LR (2009) Ustekinumab for psoriatic arthritis. Lancet 373(9664):605–606. https://doi.org/10.1016/S0140-6736(09)60141-0

    Article  PubMed  Google Scholar 

  4. Gottlieb A, Menter A, Mendelsohn A, Shen YK, Li S, Guzzo C, Fretzin S, Kunynetz R, Kavanaugh A (2009) Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet 373(9664):633–640. https://doi.org/10.1016/S0140-6736(09)60140-9

    Article  CAS  PubMed  Google Scholar 

  5. McInnes IB, Kavanaugh A, Gottlieb AB, Puig L, Rahman P, Ritchlin C, Brodmerkel C, Li S, Wang Y, Mendelsohn AM, Doyle MK (2013) Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet 382(9894):780–789. https://doi.org/10.1016/S0140-6736(13)60594-2

    Article  CAS  PubMed  Google Scholar 

  6. Ritchlin C, Rahman P, Kavanaugh A, McInnes IB, Puig L, Li S, Wang Y, Shen YK, Doyle MK, Mendelsohn AM, Gottlieb AB, PSUMMIT 2 Study Group (2014) Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis 73(6):990–999. https://doi.org/10.1136/annrheumdis-2013-204655

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Kavanaugh A, Ritchlin C, Rahman P, Puig L, Gottlieb AB, Li S, Wang Y, Noonan L, Brodmerkel C, Song M, Mendelsohn AM, McInnes IB, PSUMMIT-1 and 2 Study Groups (2014) Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT-1 and PSUMMIT-2 trials. Ann Rheum Dis 73(6):1000–1006. https://doi.org/10.1136/annrheumdis-2013-204741

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  8. Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, Li S, Wang Y, Mendelsohn AM, Song M, Zhu Y, Rahman P, McInnes IB, on behalf of the PSUMMIT 1 Study Group (2015) Maintenance of clinical efficacy and radiographic benefit through two years of ustekinumab therapy in patients with active psoriatic arthritis: results from a randomized, placebo-controlled phase III trial. Arthritis Care Res (Hoboken) 67(12):1739–1749. https://doi.org/10.1002/acr.22645

    Article  CAS  Google Scholar 

  9. Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, You Y, Li S, Song M, Randazzo B, Rahman P, McInnes IB (2016) Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2). Ann Rheum Dis 75(11):1984–1988. https://doi.org/10.1136/annrheumdis-2015-209068

    Article  CAS  PubMed  Google Scholar 

  10. Almirall M, Rodriguez J, Mateo L, Carrascosa JM, Notario J, Gallardo F (2017) Treatment with ustekinumab in a Spanish cohort of patients with psoriasis and psoriatic arthritis in daily clinical practice. Clin Rheumatol 36(2):439–443. https://doi.org/10.1007/s10067-016-3464-x

    Article  PubMed  Google Scholar 

  11. Napolitano M, Costa L, Caso F, Megna M, Scarpa R, Balato N, Ayala F, Balato A (2017) Minimal disease activity in patients with psoriatic arthritis treated with ustekinumab: results from a 24-week real-world study. Clin Rheumatol 36(7):1589–1593. https://doi.org/10.1007/s10067-017-3700-z

    Article  PubMed  Google Scholar 

  12. Rudwaleit MV, Van Der Heijde D, Landewé R, Akkoc N, Brandt J, Chou CT et al (2011) The Assessment of SpondyloArthritis International Society classification criteria for peripheral spondyloarthritis and for spondyloarthritis in general. Ann Rheum Dis 70(1):25–31. https://doi.org/10.1136/ard.2010.13364

  13. Kristensen LE, Saxne T, Geborek P (2006) The LUNDEX, a new index of drug efficacy in clinical practice: results of a five-year observational study of treatment with infliximab and etanercept among rheumatoid arthritis patients in southern Sweden. Arthritis Rheum 54:600–606

    Article  CAS  PubMed  Google Scholar 

  14. Harrold LR, Stolshek BS, Rebello S, Collier DH, Mutebi A, Wade SW, Malley W, Greenberg JD, Etzel CJ (2017) Impact of prior biologic use on persistence of treatment in patients with psoriatic arthritis enrolled in the US Corrona registry. Clin Rheumatol 36(4):895–901. https://doi.org/10.1007/s10067-017-3593-x

    Article  PubMed  Google Scholar 

  15. Coates LC, Helliwell PS (2017) Psoriatic arthritis: state of the art review. Clin Med 17(1):65–70. https://doi.org/10.7861/clinmedicine.17-1-65

    Article  Google Scholar 

  16. Haque N, Lories RJ, de Vlam K (2016) Comorbidities associated with psoriatic arthritis compared with non-psoriatic spondyloarthritis: a cross-sectional study. J Rheumatol 43(2):376–382. https://doi.org/10.3899/jrheum.141359

    Article  CAS  PubMed  Google Scholar 

  17. Li W, Han J, Qureshi AA (2012) Obesity and risk of incident psoriatic arthritis in US women. Ann Rheum Dis 71:1267–1272

    Article  PubMed  PubMed Central  Google Scholar 

  18. Iannone F, Lopalco G, Rigante D, Orlando I, Cantarini L, Lapadula G (2016) Impact of obesity on the clinical outcome of rheumatologic patients in biotherapy. Autoimmun Rev 15(5):447–450. https://doi.org/10.1016/j.autrev.2016.01.010

    Article  PubMed  Google Scholar 

  19. Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, Emery P, Landewé R, Oliver S, Aletaha D, Betteridge N, Braun J, Burmester G, Cañete 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

    Article  CAS  PubMed  Google Scholar 

  20. Fagerli KM, Lie E, van der Heijde D, Heiberg MS, Kalstad S, Rødevand E, Mikkelsen K, Lexberg ÅS, 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

    Article  CAS  PubMed  Google Scholar 

  21. Verma L, Mayba JN, Gooderham MJ, Verma A, Papp KA (2017) Persistency of biologic therapies for plaque psoriasis in 2 large community practices. J Cutan Med Surg 22(1):38–43. https://doi.org/10.1177/1203475417733957

    Article  PubMed  Google Scholar 

  22. Pogácsás L, Borsi A, Takács P, Remenyik É, Kemény L, Kárpáti S, Holló P, Wikonkál N, Gyulai R, Károlyi Z, Rakonczai P, Balázs T, Szegedi A (2017) Long-term drug survival and predictor analysis of the whole psoriatic patient population on biological therapy in Hungary. J Dermatolog Treat 28(7):635–641. https://doi.org/10.1080/09546634.2017.1329504

    Article  PubMed  Google Scholar 

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Correspondence to Florenzo Iannone.

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A correction to this article is available online at https://doi.org/10.1007/s10067-018-4033-2.

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Iannone, F., Santo, L., Bucci, R. et al. Drug survival and effectiveness of ustekinumab in patients with psoriatic arthritis. Real-life data from the biologic Apulian registry (BIOPURE). Clin Rheumatol 37, 667–675 (2018). https://doi.org/10.1007/s10067-018-3989-2

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