Drug survival and effectiveness of ustekinumab in patients with psoriatic arthritis. Real-life data from the biologic Apulian registry (BIOPURE)
Tóm tắt
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.
Tài liệu tham khảo
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
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
Cuchacovich RS, Espinoza LR (2009) Ustekinumab for psoriatic arthritis. Lancet 373(9664):605–606. https://doi.org/10.1016/S0140-6736(09)60141-0
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
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
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
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
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
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
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
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
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
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
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
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
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
Li W, Han J, Qureshi AA (2012) Obesity and risk of incident psoriatic arthritis in US women. Ann Rheum Dis 71:1267–1272
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
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
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
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
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