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04.01.2018 | Original Article

Effectiveness and safety of ustekinumab in naïve or TNF-inhibitors failure psoriatic arthritis patients: a 24-month prospective multicentric study

verfasst von: Maria Sole Chimenti, Augusta Ortolan, Mariagrazia Lorenzin, Paola Triggianese, Marina Talamonti, Luisa Costa, Francesco Caso, Marta Favero, Miriam Teoli, Marco Galluzzo, Raffaele Scarpa, Leonardo Punzi, Roberto Perricone, Roberta Ramonda

Erschienen in: Clinical Rheumatology | Ausgabe 2/2018

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Abstract

The current prospective observational study aimed to evaluate the long-term (24 months), real-life effectiveness of ustekinumab in psoriatic arthritis (PsA). Consecutive patients with moderate-severe PsA and active psoriasis who begun ustekinumab treatment were evaluated prospectively (January 2015–March 2017). Clinimetric scores and biochemical values were assessed at baseline (T0), at 6 (T6), 12 (T12), and 24 (T24) months. Friedman test and generalized linear models were used to compare variables over time. Regression analysis to identify determinants of minimal disease activity (MDA) at T6 and of treatment discontinuation was conducted. Sixty-five patients (43.1% men; age 49.4 ± 11.6 years) were enrolled; ustekinumab was prescribed as a first (20%), second (33.8%), third (26.5%), fourth (15.4%), or fifth (4.6%) line biological therapy. Significant decrease in tender/swollen joints, Visual Analogue Scale of pain (VASp) and general health (VASgh), Disease Activity in PsA (DAPSA), Psoriasis Area Severity Index (PASI), Leeds Enthesitis Index (LEI), Health Assessment Questionnaire modified for spondyloarthritis (HAQ-S), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) was achieved. MDA was reached by 30.7, 47.0, and 34.0% of patients respectively at T6, T12, and T24. In multivariable models, mono-oligoarthritis was independently associated to MDA at T6 (OR 9.02; 95% CI 1.41, 57.71), while baseline CRP (OR 1.12; 95% CI 1.00, 1.26) and LEI (OR 0.50; 95% CI 0.25, 0.97) to ustekinumab discontinuation. More patients used disease-modifying antirheumatic drugs at T0 (35.3%) than at T24 (8.5%). Only nine episodes of infection and no serious adverse events were registered. In a real-life clinical setting, ustekinumab was safe and effective in PsA. Comedication tapering was often possible.

Chandran V, Raychaudhuri SP (2010) Geoepidemiology and environmental factors of psoriasis and psoriatic arthritis. J Autoimmun 34(3):J314–J321. https://doi.org/10.1016/j.jaut.2009.12.001CrossRefPubMed

Ibrahim G, Waxman R, Helliwell PS (2009) The prevalence of psoriatic arthritis in people with psoriasis. Arthritis Rheum 61(10):1373–1378. https://doi.org/10.1002/art.24608CrossRefPubMed

Gladman DD, Antoni C, Mease P et al (2005) Psoriatic arthritis: epidemiology, clinical features, course and outcome. Ann Rheum Dis 64:14–17

McHugh NJ, Balachrishnan C, Jones SM (2003) Progression of peripheral joint disease in psoriatic arthritis: a 5-yr prospective study. Rheumatology (Oxford) 42(6):778–783. https://doi.org/10.1093/rheumatology/keg217CrossRef

Raychaudhuri SP, Raychaudhuri SK (2016) IL-23/IL-17 axis in spondyloarthritis-bench to bedside. Clin Rheumatol 35(6):1437–1441. https://doi.org/10.1007/s10067-016-3263-4CrossRefPubMed

Conti F, Ceccarelli F, Marocchi E, Magrini L, Spinelli FR, Spadaro A, Scrivo R, Valesini G (2007) Switching tumour necrosis factor alpha antagonists in patients with ankylosing spondylitis and psoriatic arthritis: an observational study over a 5-year period. Ann Rheum Dis 66(10):1393–1397. https://doi.org/10.1136/ard.2007.073569CrossRefPubMedPubMedCentral

Glatigny S, Fert I, Blaton MA, Lories RJ, Araujo LM, Chiocchia G, Breban M (2012) Proinflammatory Th17 cells are expanded and induced by dendritic cells in spondylarthritis-prone HLA-B27-transgenic rats. Arthritis Rheum 64(1):110–120. https://doi.org/10.1002/art.33321CrossRefPubMed

Abe Y, Ohtsuji M, Ohtsuji N, Lin Q, Tsurui H, Nakae S, Shirai T, Sudo K, Hirose S (2009) Ankylosing enthesitis associated with up-regulated IFN-gamma and IL-17 production in (BXSB x NZB) F(1) male mice: a new mouse model. Mod Rheumatol 19(3):316–322. https://doi.org/10.3109/s10165-009-0166-0CrossRefPubMed

Sherlock JP, Joyce-Shaikh B, Turner SP, Chao CC, Sathe M, Grein J, Gorman DM, Bowman EP, McClanahan TK, Yearley JH, Eberl G, Buckley CD, Kastelein RA, Pierce RH, LaFace DM, Cua DJ (2012) IL-23 induces spondyloarthropathy by acting on ROR-gammatþ CD3þCD4-CD8- entheseal resident T cells. Nat Med 18(7):1069–1076. https://doi.org/10.1038/nm.2817CrossRefPubMed

10.

Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M, CNTO 1275 Psoriasis Study Group (2007) A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med 356(6):580–592. https://doi.org/10.1056/NEJMoa062382CrossRefPubMed

11.

Gottlieb AB, Cooper KD, McCormick TS, Toichi E, Everitt DE, Frederick B, Zhu Y, Pendley CE, Graham MA, Ann Mascelli M (2007) A phase 1, double-blind, placebo-controlled study evaluating single subcutaneous administrations of a human interleukin-12/23 monoclonal antibody in subjects with plaque psoriasis. Curr Med Res Opin 23(5):1081–1092. https://doi.org/10.1185/030079907X182112CrossRefPubMed

12.

Kauffman CL, Aria N, Toichi E, McCormick TS, Cooper KD, Gottlieb AB, Everitt DE, Frederick B, Zhu Y, Graham MA, Pendley CE, Mascelli MA (2004) A phase I study evaluating the safety, pharmacokinetics, and clinical response of a human IL-12 p40 antibody in subjects with plaque psoriasis. J Invest Dermatol 123(6):1037–1044. https://doi.org/10.1111/j.0022-202X.2004.23448.xCrossRefPubMed

13.

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)60594-2CrossRefPubMed

14.

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-2013-204655CrossRefPubMedPubMedCentral

15.

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) PSUMMIT 1 study group. 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) 67:1739–1749, 12, DOI: https://doi.org/10.1002/acr.22645

16.

Rahman P, Puig L, Gottlieb AB, Kavanaugh A, McInnes IB, Ritchlin C, Li S, Wang Y, Song M, Mendelsohn A, Han C, PSUMMIT 1 and 2 Study Groups (2016) PSUMMIT 1 and 2 study groups. Ustekinumab treatment and improvement of physical function and health-related quality of life in patients with psoriatic arthritis. Arthritis Care Res (Hoboken) 68(12):1812–1822. https://doi.org/10.1002/acr.23000CrossRef

17.

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-xCrossRefPubMed

18.

Michel M, Reguiai Z, Fauconier M, Brochot P, Eschard JP, Salmon JH (2016) Efficacy and safety of ustekinumab in psoriatic arthritis after anti-α failure in routine practice. Therapie 71(3):281–286. https://doi.org/10.1016/j.therap.2015.07.001CrossRefPubMed

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-2015-208337CrossRefPubMed

20.

Coates LC, Kavanaugh A, Mease PJ, Soriano ER, Laura Acosta-Felquer M, Armstrong AW, Bautista-Molano W, Boehncke WH, Campbell W, Cauli A, Espinoza LR, FitzGerald O, Gladman DD, Gottlieb A, Helliwell PS, Husni ME, Love TJ, Lubrano E, McHugh N, Nash P, Ogdie A, Orbai AM, Parkinson A, O'Sullivan D, Rosen CF, Schwartzman S, Siegel EL, Toloza S, Tuong W, Ritchlin CT (2016) Group for research and assessment of psoriasis and psoriatic arthritis 2015 treatment recommendations for psoriatic arthritis. Arthritis Rheumatol 68(5):1060–1071. https://doi.org/10.1002/art.39573PubMed

21.

Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H, CASPAR Study Group (2006) CASPAR Study Group: classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 54(8):2665–2673. https://doi.org/10.1002/art.21972CrossRefPubMed

22.

Charlson ME, Pompei P, Ales KL, MacKenzie CR (1987) A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 40(5):373–383. https://doi.org/10.1016/0021-9681(87)90171-8CrossRefPubMed

23.

Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr, International Diabetes Federation Task Force on Epidemiology and Prevention, Hational Heart, Lung, and Blood Institute, American Heart Association, World Heart Federation, International Atherosclerosis Society, International Association for the Study of Obesity (2009) Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation 120(16):1640–1645. https://doi.org/10.1161/CIRCULATIONAHA.109.192644CrossRefPubMed

24.

Daltroy LH, Larson MG, Roberts WN, Liang MH (1990) A modification of the health assessment questionnaire for the spondyloarthropathies. J Rheumatol 17(7):946–950PubMed

25.

Langley RG, Ellis CN (2004) Evaluating psoriasis with psoriasis area and severity index, psoriasis global assessment, and lattice system physician’s global assessment. J Am Acad Dermatol 51(4):563–569. https://doi.org/10.1016/j.jaad.2004.04.012CrossRefPubMed

26.

Helliwell PS, Fitzgerald O, Fransen J et al (2013) The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project). Ann Rheum Dis 72(6):986–989. https://doi.org/10.1136/annrheumdis-2012-201341CrossRefPubMed

27.

Healy PJ, Helliwell PS (2008) Measuring clinical enthesitis in psoriatic arthritis: assessment of existing measures and development of an instrument specific to psoriatic arthritis. Arthritis Care Res 59(5):686–691. https://doi.org/10.1002/art.23568CrossRef

28.

Coates L, Helliwell P (2010) Validation of minimal disease activity criteria for psoriatic arthritis using interventional trial data. Arthritis Care Res 62(7):965–969. https://doi.org/10.1002/acr.20155CrossRef

29.

http://www.ema.europa.eu/docs/it_IT/document_library/EPAR__Product_Information/human/000958/WC500058513.pdf

30.

Iervolino S, Di Minno MN, Peluso R et al (2012) Predictors of early minimal disease activity in patients with psoriatic arthritis treated with tumor necrosis factor-α blockers. J Rheumatol 39(3):568–573. https://doi.org/10.3899/jrheum.110763CrossRefPubMed

31.

Chimenti MS, Triggianese P, Conigliaro P, Tonelli M, Gigliucci G, Novelli L, Teoli M, Perricone R (2017) A 2-year observational study on treatment targets in psoriatic arthritis patients treated with TNF inhibitors. Clin Rheumatol 36(10):2253–2260. https://doi.org/10.1007/s10067-017-3769-4CrossRefPubMed

32.

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/s10067-016-3425-4CrossRefPubMed

33.

Marchesoni A, Lubrano E, Manara M, Ramonda R, Salvarani C, Olivieri I (2016) Current approach to the management of psoriatic arthritis according to a sample of Italian rheumatologists. Clin Exp Rheumatol 34(6):1051–1058PubMed

34.

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-zCrossRefPubMed

35.

Zhao S, Challoner B, Khattak M, Moots RJ, Goodson NJ (2017) Increasing smoking intensity is associated with increased disease activity in axial spondyloarthritis. Rheumatol Int 37(2):239–244. https://doi.org/10.1007/s00296-016-3590-4CrossRefPubMed

36.

Haroon N, Inman RD, Learch TJ, Weisman MH, Lee M, Rahbar MH, Ward MM, Reveille JD, Gensler LS (2013) The impact of tumor necrosis factor α inhibitors on radiographic progression in ankylosing spondylitis. Arthritis Rheum 65(10):2645–2654. https://doi.org/10.1002/art.38070PubMedPubMedCentral

37.

Højgaard P, Glintborg B, Kristensen LE, Gudbjornsson B, Love TJ, Dreyer L (2016) The influence of obesity on response to tumour necrosis factor-α inhibitors in psoriatic arthritis: results from the DANBIO and ICEBIO registries. Rheumatology (Oxford) 55(12):2191–2199. https://doi.org/10.1093/rheumatology/kew326CrossRef

38.

Rosas J, Llinares-Tello F, Senabre-Gallego JM, Barber-Vallés X, Santos-Soler G, Salas-Heredia E, Pons Bas A, Cano Pérez C, García-Carrasco M, and the AIRE-MB Group (2017) The AIRE-MB group. Obesity decreases clinical efficacy and levels of adalimumab in patients with ankylosing spondylitis. Clin Exp Rheumatol 35:145–148, 1

39.

Baranauskaite A, Raffayová H, Kungurov NV, Kubanova A, Venalis A, Helmle L, Srinivasan S, Nasonov E, Vastesaeger N, RESPOND investigators (2012) Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study. Ann Rheum Dis 71(4):541–548. https://doi.org/10.1136/ard.2011.152223CrossRefPubMed

40.

Gossec L, Coates LC, de Wit M, Kavanaugh A, Ramiro S, Mease PJ, Ritchlin CT, van der Heijde D, Smolen JS (2016) Management of psoriatic arthritis in 2016: a comparison of EULAR and GRAPPA recommendations. Nat Rev Rheumatol 12(12):743–750. https://doi.org/10.1038/nrrheum.2016.183CrossRefPubMed

41.

Ghiti Moghadam M, Vonkeman HE, Ten Klooster PM et al (2016) Stopping tumor necrosis factor inhibitor treatment in patients with established rheumatoid arthritis in remission or with stable low disease activity: a pragmatic multicenter, open-label randomized controlled trial. Arthritis Rheumatol 68(8):1810–1817. https://doi.org/10.1002/art.39626CrossRefPubMed

42.

Chimenti MS, Graceffa D, Perricone R (2011) Anti-TNFα discontinuation in rheumatoid and psoriatic arthritis: is it possible after disease remission? Autoimmun Rev 10(10):636–640. https://doi.org/10.1016/j.autrev.2011.04.015CrossRefPubMed

43.

López-Ferrer A, Laiz A, Puig L (2017) The safety of ustekinumab for the treatment of psoriatic arthritis. Expert Opin Drug Saf 16(6):733–734. https://doi.org/10.1080/14740338.2017.1323864CrossRefPubMed

44.

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-2015-209068CrossRefPubMed

Titel: Effectiveness and safety of ustekinumab in naïve or TNF-inhibitors failure psoriatic arthritis patients: a 24-month prospective multicentric study
verfasst von: Maria Sole Chimenti
Augusta Ortolan
Mariagrazia Lorenzin
Paola Triggianese
Marina Talamonti
Luisa Costa
Francesco Caso
Marta Favero
Miriam Teoli
Marco Galluzzo
Raffaele Scarpa
Leonardo Punzi
Roberto Perricone
Roberta Ramonda
Publikationsdatum: 04.01.2018
Verlag: Springer London
Erschienen in: Clinical Rheumatology / Ausgabe 2/2018
Print ISSN: 0770-3198
Elektronische ISSN: 1434-9949
DOI: https://doi.org/10.1007/s10067-017-3953-6

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Effectiveness and safety of ustekinumab in naïve or TNF-inhibitors failure psoriatic arthritis patients: a 24-month prospective multicentric study

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