Ustekinumab Is Rapid-Acting and Is an Effective Long-Term Treatment for Patients with Active Psoriatic Arthritis: Real-World Evidence from the Non-interventional SUSTAIN Study

被引:2
作者
Wendler, Joerg [1 ]
Damann, Nils [2 ]
Roecken, Marit [2 ]
Teicher, Verena [2 ]
Schuier, Maximilian [2 ]
Hamann, Frank [3 ]
Schwenke, Holger [4 ]
Sieburg, Maren [5 ]
Behrens, Frank [6 ]
机构
[1] Rheumatol Schwerpunktpraxis, Erlangen, Germany
[2] Janssen Cilag, Neuss, Germany
[3] Gemeinschaftspraxis Internist Rheumatol, Leipzig, Germany
[4] Rheumatol MVZ, Dresden, Germany
[5] Rheumatol Facharztpraxis, Magdeburg, Germany
[6] Goethe Univ, Rheumatol & Fraunhofer Inst TMP, Frankfurt, Germany
关键词
Long-term efficacy; Psoriatic arthritis; Real world; Tolerability; Ustekinumab; MONOCLONAL-ANTIBODY; DRUG SURVIVAL; DOUBLE-BLIND; SAFETY; EFFICACY; RECOMMENDATIONS; MULTICENTER; BIOLOGICS; PHASE-3;
D O I
10.1007/s40744-022-00484-3
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction Psoriatic arthritis (PsA) is a chronic, progressive disease that places a significant burden on patients and healthcare systems. The SUSTAIN study collected real-world evidence on long-term effectiveness, impact on quality of life, and safety of ustekinumab treatment for PsA. Methods SUSTAIN was a prospective, non-interventional study conducted in Germany. Patients with active PsA received ustekinumab for 160 weeks in routine clinical care, with assessments at baseline, week 4, and every 12 weeks thereafter. This analysis focuses on patients who remained in SUSTAIN until week 160. Results Of 337 patients enrolled, 129 were documented at week 160, of which 123 (95.3%) had received previous PsA medication, including biologics. Decreases from baseline to week 4 were observed for tender joint count (TJC, 8.0 to 5.8) and swollen joint count (SJC, 4.5 to 3.1); these decreases continued to week 28 and were maintained to week 160 (1.0 and 0.4, respectively). Similarly, skin assessments in patients with PsA and psoriasis revealed improvement at week 4, which continued to week 28, with a sustained effect until week 160. Similar patterns of response were observed for patient-assessed pain, sleep quality, and health scores. Improvements in TJC, SJC, Psoriasis Area and Severity Index, and affected body surface area were observed irrespective of the number of prior biologic therapies used. Minimal disease activity was achieved by 36 (31.9%) patients at week 28, and by 38 (33.6%) at week 52. Ustekinumab-related adverse events (AEs) and serious AEs were reported in 61 (47.3%) and 4 (3.1%) patients, respectively. At week 160, 100% of patients assessed ustekinumab tolerability as good or very good. Conclusions In a real-world setting, patients with active PsA who received ustekinumab until 160 weeks (3 years), including those who received prior biologic therapies, had a rapid onset of effect and sustained response to treatment, with high tolerability.
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收藏
页码:1435 / 1450
页数:16
相关论文
共 22 条
[1]   Discovery and mechanism of ustekinumab A human monoclonal antibody targeting interleukin-12 and interleukin-23 for treatment of immune-mediated disorders [J].
Benson, Jacqueline M. ;
Peritt, David ;
Scallon, Bernard J. ;
Heavner, George A. ;
Shealy, David J. ;
Giles-Komar, Jill M. ;
Mascelli, Mary Ann .
MABS, 2011, 3 (06) :535-545
[2]   Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment [J].
Coates, L. C. ;
Fransen, J. ;
Helliwell, P. S. .
ANNALS OF THE RHEUMATIC DISEASES, 2010, 69 (01) :48-53
[3]   Measurement properties of the minimal disease activity criteria for psoriatic arthritis [J].
Coates, Laura C. ;
Strand, Vibeke ;
Wilson, Hilary ;
Revicki, Dennis ;
Stolshek, Brad ;
Samad, Ahmed ;
Chung, James B. ;
Gladman, Dafna ;
Mease, Philip J. .
RMD OPEN, 2019, 5 (02)
[4]   Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015 Treatment Recommendations for Psoriatic Arthritis [J].
Coates, Laura C. ;
Kavanaugh, Arthur ;
Mease, Philip J. ;
Soriano, Enrique R. ;
Acosta-Felquer, Maria Laura ;
Armstrong, April W. ;
Bautista-Molano, Wilson ;
Bochncke, Wolf -Henning ;
Campbc, Willemina ;
Cauli, Alberto ;
Espinoza, Luis R. ;
FitzGerald, Oliver ;
Gladman, Dafna D. ;
Gottlieb, Alice ;
Helliwel, Philip S. ;
Husni, M. Elaine ;
Love, Thorvardur J. ;
Lubrano, Ennio ;
McHugh, Neil ;
Nash, Peter ;
Ogdie, Alexis ;
Orbai, Ana -Maria ;
Parkinson, Andrew ;
O'Sullivan, Denis ;
Rosen, Cheryl F. ;
Schwartzman, Sergio ;
Siege, Evan L. ;
Toloza, Sergio ;
Tuong, William ;
Ritchlin, Christopher T. .
ARTHRITIS & RHEUMATOLOGY, 2016, 68 (05) :1060-1071
[5]   Psoriatic arthritis: state of the art review [J].
Coates, Laura C. ;
Helliwell, Philip S. .
CLINICAL MEDICINE, 2017, 17 (01) :65-70
[6]   Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis [J].
Egeberg, A. ;
Ottosen, M. B. ;
Gniadecki, R. ;
Broesby-Olsen, S. ;
Dam, T. N. ;
Bryld, L. E. ;
Rasmussen, M. K. ;
Skov, L. .
BRITISH JOURNAL OF DERMATOLOGY, 2018, 178 (02) :509-519
[7]  
European Medicines Agency, STEL UST
[8]  
Husted JA, 1997, J RHEUMATOL, V24, P511
[9]   Drug survival and effectiveness of ustekinumab in patients with psoriatic arthritis. Real-life data from the biologic Apulian registry (BIOPURE) [J].
Iannone, Florenzo ;
Santo, Leonardo ;
Bucci, Romano ;
Semeraro, Angelo ;
Carlino, Giorgio ;
Paoletti, Franco ;
Quarta, Laura ;
Leucci, Pierfrancesco ;
Zuccaro, Carmelo ;
Marsico, Antonio ;
Scioscia, Crescenzio ;
D'Onofrio, Francesca ;
Mazzotta, Daniela ;
Muratore, Maurizio ;
Cantatore, Francesco Paolo ;
Lapadula, Giovanni .
CLINICAL RHEUMATOLOGY, 2018, 37 (03) :667-675
[10]  
Janssen Biotech Inc, 2012, HIGHL PRESCR INF STE