Long-term effectiveness and persistence of ustekinumab and TNF inhibitors in patients with psoriatic arthritis: final 3-year results from the PsABio real-world study

被引:11
|
作者
Gossec, Laure [1 ,2 ]
Siebert, Stefan [3 ]
Bergmans, Paul [4 ]
de Vlam, Kurt [5 ]
Gremese, Elisa [6 ]
Joven-Ibanez, Beatriz [7 ]
Korotaeva, Tatiana, V [8 ]
Lavie, Frederic [9 ]
Noel, Wim [10 ]
Nurmohamed, Michael T. [11 ,12 ]
Sfikakis, Petros P. [13 ]
Sharaf, Mohamed [14 ]
Theander, Elke [15 ]
Smolen, Josef S. [16 ]
机构
[1] Sorbonne Univ, Inst Pierre Louis Epidemiol & Sante Publ, INSERM, F-75013 Paris, France
[2] Hop La Pitie Salpetriere, AP HP, Rheumatol Dept, Paris, France
[3] Univ Glasgow, Glasgow, Lanark, Scotland
[4] Janssen Cilag BV, Breda, Netherlands
[5] Univ Hosp Leuven, Leuven, Belgium
[6] Univ Cattolica Sacro Cuore, Fdn Policlin A Gemelli IRCCS, Rome, Italy
[7] Univ Hosp 12 Octubre, Madrid, Spain
[8] VA Nasonova Res Inst Rheumatol, Moscow, Russia
[9] Janssen Pharmaceut Co Johnson & Johnson, Paris, France
[10] Janssen Pharmaceut NV, Beerse, Belgium
[11] Reade, Amsterdam, Netherlands
[12] Vrije Univ Amsterdam Med Ctr, Amsterdam, Netherlands
[13] Natl & Kapodistrian Univ Athens Med Sch, Athens, Greece
[14] Johnson & Johnson Middle East, Dubai, U Arab Emirates
[15] Janssen, Solna, Sweden
[16] Med Univ Vienna, Vienna, Austria
关键词
Arthritis; Psoriatic; Biological Therapy; Tumor Necrosis Factor Inhibitors; DISEASE-ACTIVITY STATES; DOUBLE-BLIND; MANAGEMENT; SAFETY; MULTICENTER; BIOLOGICS; EFFICACY; THERAPY; PHASE-3;
D O I
10.1136/ard-2022-222879
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ObjectivesTo evaluate real-world persistence and effectiveness of the IL-12/23 inhibitor, ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis over 3 years. MethodsPsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or a TNFi. Persistence and effectiveness (achievement of clinical Disease Activity for PSA (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very LDA (MDA/VLDA)) were assessed every 6 months. Safety data were collected over 3 years. Analyses to compare the modes of action were adjusted on baseline differences by propensity scores (PS). ResultsIn 895 patients (mean age 49.8 years, 44.7% males), at 3 years, the proportion of patients still on their initial treatments was similar with ustekinumab (49.9%) and TNFi (47.8%). No difference was seen in the risk of stopping/switching; PS-adjusted hazard ratio (95% CI) for stopping/switching ustekinumab versus TNFi was 0.87 (0.68 to 1.11). In the overall population, cDAPSA LDA/remission was achieved in 58.6%/31.4% ustekinumab-treated and 69.8%/45.0% TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.89 (0.63 to 1.26) for cDAPSA LDA; 0.72 (0.50 to 1.05) for remission. MDA/VLDA was achieved in 41.4%/19.2% of ustekinumab-treated and 54.2%/26.9% of TNFi-treated patients with overlapping PS-adjusted ORs. A greater percentage of TNFi-treated patients achieved effectiveness outcomes. Both treatments exhibited good long-term safety profiles, although ustekinumab-treated patients had a lower rate of adverse events (AEs) versus TNFi. ConclusionAt 3 years, there was generally comparable persistence after ustekinumab or TNFi treatment, but AE rates were lower with ustekinumab.
引用
收藏
页码:496 / 506
页数:11
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