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

Eva Galíndez-Agirregoikoa; Diana Prieto-Peña; José Luis Martín-Varillas; Beatriz Joven; Olga Rusinovich; Rafael B Melero-González; Francisco Ortiz-Sanjuan; Raquel Almodóvar; Juan José Alegre-Sancho; Ángels Martínez; Agustí Sellas-Fernández; Lara Méndez; Rosario García-Vicuña; Belén Atienza-Mateo; Iñigo Gorostiza; Miguel Ángel González-Gay; Ricardo Blanco; Tofacitinib PsA Clinical Practice Collaborative Group

doi:10.3899/jrheum.201204

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

J Rheumatol. 2021 Oct;48(10):1552-1558. doi: 10.3899/jrheum.201204. Epub 2021 Apr 1.

Authors

Eva Galíndez-Agirregoikoa¹, Diana Prieto-Peña², José Luis Martín-Varillas³, Beatriz Joven⁴, Olga Rusinovich⁵, Rafael B Melero-González⁶, Francisco Ortiz-Sanjuan⁷, Raquel Almodóvar⁸, Juan José Alegre-Sancho⁹, Ángels Martínez⁹, Agustí Sellas-Fernández¹⁰, Lara Méndez¹¹, Rosario García-Vicuña¹², Belén Atienza-Mateo², Iñigo Gorostiza¹³, Miguel Ángel González-Gay¹⁴, Ricardo Blanco¹⁵; Tofacitinib PsA Clinical Practice Collaborative Group

Collaborators

Affiliations

¹ E. Galíndez-Agirregoikoa, MD, Rheumatology Department, Hospital Universitario de Basurto, Bilbao.
² D. Prieto-Peña, MD, B. Atienza-Mateo, MD, R. Blanco, MD, PhD, Rheumatology Department, Hospital Universitario Marqués de Valdecilla, Epidemiology, Genetics and Atherosclerosis Research Group on Systemic Inflammatory Diseases, Rheumatology Division, Santander.
³ J.L. Martín-Varillas, MD, Rheumatology Department, Hospital de Sierrallana, Torrelavega.
⁴ B. Joven, MD, Rheumatology Department, Hospital Universitario 12 de Octubre, Madrid.
⁵ O. Rusinovich, MD, Rheumatology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid.
⁶ R.B. Melero-González, MD, Rheumatology Department, Complexo Hospitalario Universitario de Vigo, Vigo.
⁷ F. Ortiz-Sanjuan, MD, PhD, Rheumatology Department, Hospital Universitario Politécnico La Fé, Valencia.
⁸ R. Almodóvar, MD, Rheumatology Department, Fundación Alcorcón, Madrid.
⁹ J.J. Alegre-Sancho, MD, Á. Martínez, MD, Rheumatology Department, Hospital Universitario Doctor Peset, Valencia.
¹⁰ A. Sellas-Fernández, MD, Rheumatology Department, Hospital Universitari Arnau de Vilanova-Lleida, Lleida.
¹¹ L. Méndez, MD, Rheumatology Department, Hospital Virgen del Rocío, Sevilla.
¹² R. García-Vicuña, MD, PhD, Rheumatology Department, Hospital de la Princesa, IIS-Princesa, Cátedra UAM-Roche (EPID-Future), Universidad Autónoma de Madrid, Madrid.
¹³ I. Gorostiza, MD, Research Group, Hospital Universitario de Basurto, Bilbao.
¹⁴ M.Á. González-Gay, MD, PhD, Rheumatology Department, Hospital Universitario Marqués de Valdecilla, Epidemiology, Genetics and Atherosclerosis Research Group on Systemic Inflammatory Diseases, Rheumatology Division, and University of Cantabria, School of Medicine, Santander, Spain, and Cardiovascular Pathophysiology and Genomics Research Unit, School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
¹⁵ D. Prieto-Peña, MD, B. Atienza-Mateo, MD, R. Blanco, MD, PhD, Rheumatology Department, Hospital Universitario Marqués de Valdecilla, Epidemiology, Genetics and Atherosclerosis Research Group on Systemic Inflammatory Diseases, Rheumatology Division, Santander; rblanco@humv.es miguelaggay@hotmail.com.

PMID: 33795330
DOI: 10.3899/jrheum.201204

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: biologic therapy; clinical practice; psoriatic arthritis; real-world data; tofacitinib.

Publication types

Multicenter Study
Observational Study

MeSH terms

Adult
Arthritis, Psoriatic* / drug therapy
Female
Humans
Male
Middle Aged
Piperidines
Pyrimidines / therapeutic use*
Pyrroles / therapeutic use*
Treatment Outcome

Substances

Piperidines
Pyrimidines
Pyrroles
tofacitinib