Upadacitinib in Refractory Psoriatic Arthritis. Multicenter Study of 134 Patients in Clinical Practice

Eva Galindez-Agirregoikoa¹, Diana Prieto-Peña², Maria Luz Garcia Vivar¹, Lucia Vega-Alvarez¹, Cristina Vergara³, Irati Urionaguena⁴, Consuelo Ramos-Giráldez⁵, Raquel Almodovar⁶, Beatriz Joven Ibáñez⁷, Rosario Garcia-Vicuna⁸, Vega Jovani⁹, Teresa González¹⁰, Àngels Martínez-Ferrer¹¹, Ana Urruticoechea Arana¹², Bryan Josue Flores Robles¹³, Cristina Campos Fernández¹⁴, Lilian Maria Lopez Nunez¹⁵, Joaquin Maria Belzunegui Otano¹⁶, Marina Pavia Pascual¹⁷, Esteban Rubio¹⁸, Angel Ramos-Calvo¹⁹, Noemi Busquets²⁰, Ana Pérez Gómez²¹, Francisco Miguel Ortiz Sanjuan²², Rafael Benito Melero-Gonzalez²³, Cristina Macía²⁴, María Ángeles Puche Larrubia²⁵, Jose Antonio Pinto Tasende²⁶, Cristina Fernandez²⁷, Maria Paz Martinez-Vidal²⁸, Jaime Calvo- Alén²⁹, Emma Beltran-Catalan³⁰, Mireia Moreno³¹, Silvia Pérez-Barrio³², iñigo Gorostiza Hormaeche¹ and Ricardo Blanco³³, ¹Basurto University Hospital, Bilbao, Spain, ²Hospital Universitario Marqués de Valdecilla, Santander, Spain, ³Hospital Universitario Infanta Sofía, Madrid, Spain, ⁴GALDAKAO-USANSOLO UNIVERSITY HOSPITAL, GERNIKA-LUMO, Spain, ⁵Rheumatology Department Hospital Universitario Virgen de Valme, Sevilla, Spain, ⁶Alcorcón Foundation University Hospital, Madrid, Spain, ⁷Hospital Universitario 12 de Octubre, Madrid, Spain, ⁸Hospital Universitario de la Princesa, Madrid, Spain, ⁹Department of Rheumatology, Hospital General Universitario Dr. Balmis, Alicante, Spain, ¹⁰Hospital General Universitario Gregorio Marañón, Madrid, Spain, ¹¹Hospital Universitario Dr Peset Valéncia, Valéncia, Spain, ¹²Hospital Can Misses, Ibiza, Spain, ¹³Hospital Universitario San Pedro, Logroño, Spain, ¹⁴Hospital General Universitario Valencia, Valencia, Spain, ¹⁵Son llatzer, Palmanyola, Spain, ¹⁶University Hospital Donostia, Donostia-San Sebasti, Spain, ¹⁷Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain, ¹⁸Servicio Andaluz Salud, Sevilla, Spain, ¹⁹Complejo Hospitalario de Soria, Soria, Spain, ²⁰HOSP. GENERAL DE GRANOLLERS, GRANOLLERS, Spain, ²¹Rheumatology, Hospital Principe de Asturias, Alcalá de Henares, Spain, ²²Hospital Universitario y Politecnico La Fe, Valencia, Spain, ²³CHU Vigo, O Carballino, Spain, ²⁴Hospital Universitario Ramón y Cajal, Madrid, Spain, ²⁵Department of Rheumatology, Reina Sofia University Hospital, Cordoba, Spain, ²⁶Rheumatology department, Complexo Hospitalario Universitario A Coruña (CHUAC). Instituto de Investigación Biomédica A Coruña (INIBIC), A Coruña, Spain, ²⁷Hospital Universitario San Juan de Alicante, Alicante, Spain, ²⁸Hospital Universitario San Juan Alicante, Alicante, Spain, ²⁹Rheumatology, Bioaraba Research Unit, Hospital Universitario Araba, Vitoria, Spain, ³⁰HOSPITAL DEL MAR, Barcelona, Spain, ³¹Parc Tauli Hospital Universitari, I3PT(UAB), Barcelona, Spain, ³²Hospital Universitario de Basurto, Bilbao, Spain, ³³Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain

Meeting: ACR Convergence 2023

Keywords: Disease-Modifying Antirheumatic Drugs (Dmards), Psoriatic arthritis, spondyloarthritis

Session Information

Date: Tuesday, November 14, 2023

Title: (2227–2256) Spondyloarthritis Including Psoriatic Arthritis – Treatment: SpA Poster III

Session Type: Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: The EMA authorized Upadacitinib (UPA) in PsA in January 2021. UPA has shown efficacy in PsA refractory to anti-TNF in a clinical trial (RCT). Our objectives are: a) to study the effectiveness and safety of UPA in the 1st clinical practice (RWE) cases in Spain and b) to compare RWE patients with those of RCT.

Methods: Multicenter study of 134 patients with PsA treated with UPA in Spain. The diagnosis of PsA was made using CASPAR criteria. Patients with refractory PsA from 29 Rheumatology Services (January 2021-January 2023) who had received ≥1 dose of UPA (15 mg/d) with at least 1 follow-up visit were included. Refractory PsA was defined if low clinical activity or remission had not been achieved with biological (b) and/or targeted synthetic (ts) DMARDs.

The outcomes were the effectiveness, safety and saving of corticosteroids (CS). A comparative study was carried out between this RWE cohort and those of the SELECT-PsA 2 RCT.

Results are expressed as percentages, mean±SD or median [IQR] depending on the distribution of the variable.

Results: 134 patients (97 women) were studied, mean age 51.8±11.2 years (Table 1). The joint pattern was: peripheral (61.9%), mixed (30.6%) and axial (7.5%). During the evolution, they had also presented enthesitis (35.3%), dactylitis (25.4%), skin involvement (73.9%) and onychopathy (24.4%).

Prior to the UPA, they had received oral CS (68.7%) (mean maximum dose of prednisone 13.4±9.3) and a mean per patient of csDMARDs (1.8±1.0) and b-DMARD (3.3±2.2). The b-DMARDs were: Adalimumab (n=101), Secukinumab (66), Etanercept (53), Ixekizumab (44), Ustekinumab (44), Certolizumab (37), Infliximab (30), Golimumab (26), Guselkumab (2), Abatacept (2), Brodalumab (1). In addition, they received the following ts-DMARDs: Tofacitinib (n=29), Apremilast (27), Filgotinib (1).

UPA at baseline was associated with: a) prednisone (43.3%; mean dose 8.3±5.6 mg/d). b) csDMARDs (n=64; 47.8%): MTX (n=39), LEF (19), SSZ (10). At the start of the UPA they presented peripheral arthritis (78.4%), axial activity (29.1%), skin involvement (25.4%), onychopathy (11.3%), enthesitis (21.6%) and dactylitis (10.5%). After a mean follow-up of 5.9±5.1 months, a rapid and sustained improvement was observed in the activity indices (table 2, figure) and in the laboratory tests (table 2).

At the 6th month, an improvement in axial involvement (35.7%) and extra-articular manifestations was observed: dactylitis (80%), enthesitis (53.8%) and skin involvement (69.2%), as well as a CS-sparing effect (p=0.031) (table 2).

The RWE patients compared to the RCT were mostly women, refractory to a greater number of previous b-DMARDs and received more concomitant CS (Table 1).

No serious adverse effects (AE) were observed. Minor AE were reported in 23 (17.2%) patients. UPA was discontinued in 44 (32.8%) (28 ineffectiveness, 4 patient decision, 4 infection, 2 de novo anterior uveitis episodes, 1 thrombosis, 1 surgery, 1 pregnancy, 1 urticaria and 1 diarrhea).

Conclusion: In this study, the first patients treated with UPA in PsA in RWE in Spain received more CS simultaneously and were refractory to a greater number of b-DMARDs than those in the RCT. As in the RCT, UPA was effective, fast, and relatively safe in refractory APs in RWE.

TABLE 1. Baseline characteristics

TABLE 2. Evolution

Figure

Disclosures: E. Galindez-Agirregoikoa: None; D. Prieto-Peña: None; M. Garcia Vivar: None; L. Vega-Alvarez: None; C. Vergara: None; I. Urionaguena: None; C. Ramos-Giráldez: None; R. Almodovar: None; B. Joven Ibáñez: None; R. Garcia-Vicuna: None; V. Jovani: None; T. González: None; À. Martínez-Ferrer: None; A. Urruticoechea Arana: None; B. Flores Robles: None; C. Campos Fernández: None; L. Lopez Nunez: None; J. Belzunegui Otano: None; M. Pavia Pascual: None; E. Rubio: None; A. Ramos-Calvo: None; N. Busquets: None; A. Pérez Gómez: None; F. Ortiz Sanjuan: None; R. Melero-Gonzalez: None; C. Macía: None; M. Puche Larrubia: None; J. Pinto Tasende: None; C. Fernandez: None; M. Martinez-Vidal: None; J. Calvo- Alén: AbbVie, 2, AstraZeneca, 2, Biogen, 6, BMS, 5, Galapagos, 6, GSK, 2, 6, Lilly, 2, 6, Novartis, 2, 6, Roche, 5, Sanofi, 2; E. Beltran-Catalan: None; M. Moreno: None; S. Pérez-Barrio: None; i. Gorostiza Hormaeche: None; R. Blanco: AbbVie, 5, 6, Amgen, 6, AstraZeneca, 2, BMS, 6, Eli Lilly, 6, Galapagos, 2, 6, Janssen, 2, 6, MSD, 6, Novartis, 2, 6, Pfizer, 2, 6, Roche, 5, 6, Sanofi, 6.

To cite this abstract in AMA style:

Galindez-Agirregoikoa E, Prieto-Peña D, Garcia Vivar M, Vega-Alvarez L, Vergara C, Urionaguena I, Ramos-Giráldez C, Almodovar R, Joven Ibáñez B, Garcia-Vicuna R, Jovani V, González T, Martínez-Ferrer À, Urruticoechea Arana A, Flores Robles B, Campos Fernández C, Lopez Nunez L, Belzunegui Otano J, Pavia Pascual M, Rubio E, Ramos-Calvo A, Busquets N, Pérez Gómez A, Ortiz Sanjuan F, Melero-Gonzalez R, Macía C, Puche Larrubia M, Pinto Tasende J, Fernandez C, Martinez-Vidal M, Calvo- Alén J, Beltran-Catalan E, Moreno M, Pérez-Barrio S, Gorostiza Hormaeche i, Blanco R. Upadacitinib in Refractory Psoriatic Arthritis. Multicenter Study of 134 Patients in Clinical Practice [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/upadacitinib-in-refractory-psoriatic-arthritis-multicenter-study-of-134-patients-in-clinical-practice/. Accessed .

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