Treatment With Tofacitinib in Refractory Psoriatic Arthritis: A National Multicenter Study of the First 87 Patients in Clinical Practice

医学 托法替尼 银屑病性关节炎 血沉 最后 内科学 强的松 胃肠病学 痹症科 外科 耐火材料(行星科学) 类风湿性关节炎 不利影响 随机对照试验 天体生物学 物理
作者
E. Galíndez-Agirregoikoa,D. Prieto-Peña,J. L. Martín-Varillas,Beatriz Joven,O. Rusinovich,Rafael Benito Melero-González,Francisco Ortiz-Sanjuán,Raquel Almodóvar,Juan José Alegre Sancho,Ángels Martínez,Agustí Sellas,Lara Méndez,Rosario García‐Vicuña,Belén Atienza‐Mateo,Iñigo Gorostiza,Miguel Á. González-Gay,Ricardo Blanco
出处
期刊:The Journal of Rheumatology [The Journal of Rheumatology]
卷期号:48 (10): 1552-1558 被引量:3
标识
DOI:10.3899/jrheum.201204
摘要

Tofacitinib (TOF) is the first Janus kinase (JAK) inhibitor approved for psoriatic arthritis (PsA). It has shown efficacy in patients refractory to anti-tumor necrosis factor-α in randomized controlled trials (RCTs). Our aim was to assess efficacy and safety of TOF in clinical practice.This was an observational, open-label multicenter study of PsA patients treated with TOF due to inefficacy or adverse events of previous therapies. Outcome variables were efficacy, corticosteroid dose-sparing effect, retention rate, and safety. A comparative study of clinical features between our cohort of patients and those from the OPAL Beyond trial was performed.There were 87 patients (28 women/59 men), with a mean age of 52.8 ± 11.4 years. All patients were refractory to biologic disease-modifying antirheumatic drugs (DMARDs) and/or to conventional synthetic DMARDs plus apremilast. TOF was started at 5 mg twice daily after a mean follow-up of 12.3 ± 9.3 years from PsA diagnosis. At first month, Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) decreased from median 4.8 (IQR 4.1-5.4) to 3.7 (IQR 2.8-4.7, P < 0.01), Disease Activity Index for Psoriatic Arthritis from median 28 (IQR 18.4-34.1) to 15.5 (IQR 10.1-25.7, P < 0.01), and C-reactive protein from median 1.9 (IQR 0.3-5.0) to 0.5 (IQR 0.1-2.2) mg/dL (P < 0.01). Also, TOF led to a significant reduction in prednisone dose. Mild adverse effects were reported in 21 patients (24.13%), mainly gastrointestinal symptoms. TOF retention rate at Month 6 was 77% (95% CI 65.2-86.3). Patients in clinical practice were older with longer disease duration and received biologic agents more commonly than those in the OPAL Beyond trial.Data from clinical practice confirm that TOF seems to be effective, rapid, and relatively safe in refractory PsA despite clinical differences with patients in RCTs.
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