PO:08:126 | Use of upadacitinib in real-life: the experience of Calabrian rheumatology

Vincenzo Raimondo¹, Maurizio Caminiti², Pietro Gigliotti³, Giuseppe Varcasia⁴, Massimo L'Andolina⁵, Domenico Olivo⁶, Roberta Pellegrini⁷, Pietro Muto⁸, Marilena Calabria⁹, Laura Massaro¹⁰, Jessica Maria El Luppino¹¹, Salvatore De Bonis¹², Giuseppa Pagano Mariano², Stefania Sorbara³, Virginia Caira⁴, Mariateresa Cirillo⁵, Caterina Bruno⁹, Clodoveo Ferri¹¹ | ¹UOC di Reumatologia, Dipartimento SCIAC, Sapienza Università di Roma; ²Dipartimento di Medicina, Clinica di Reumatologia, Università degli Studi di Udine; ³UOC Medicina Interna e Nefrologia, Dipartimento MeSVA, Università degli Studi di L'Aquila; ⁴UniCamillus, San Camillo Università Internazionale di Scienze della Salute di Roma, Italy; ⁵Ambulatorio di Reumatologia, Ospedale di Tropea, Tropea, Italy; ⁶ASP Crotone, Ambulatorio di Reumatologia, Crotone, Italy; ⁷Ambulatorio di Reumatologia, Ospedale Annunziata di Cosenza, Cosenza, Italy; ⁸Ambulatorio di Reumatologia, Ospedale di Paola, Paola, Italy; ⁹Ambulatorio di Reumatologia, SOC di Medicina Interna, AOU Dulbecco, Catanzaro, Italy; ¹⁰Ambulatorio di Reumatologia, Ospedale di Praia a Mare, Praia a Mare, Italy; ¹¹Casa di Cura Madonna dello Scoglio, Reparto di Reumatologia, Cotronei, Italy - Affiliazione 12: Ambulatorio di Reumatologia, ospedale di Acri, Acri, Italy  

Background. Upadacitinib (UPA), demonstrated efficacy and safety in the treatment of Rheumatoid Arthritis (RA) in several randomized clinical trials (RCTs) and in long-term extension (LTE) studies. However, it is well known that experiences in real world evidence (RWE) play a pivotal and complementary role to RCTs. On this basis, Calabrian rheumatologists has decided to collect data aiming at providing futher evidences on the efficacy and safety of UPA in RA patients.

Materials and Methods. To evaluate efficacy and safety, 87 RA patients (>18 years old) were enrolled retrospectively from January 2021 to December 2023 from 11 different Rheumatology Units in Calabria. Data were collected at baseline and the at 3, 6, 12 and 24 months from the start of therapy, including demographic features, prior therapies, comorbidities, RA features, clinimetric data and adverse events (AEs). Of the 87 enrolled patients, 80.5% are women. The mean age is 61.4 ± 10.9 years. The median disease duration is 96 months. The mean BMI is 26.07± 5.23. Eight patients (9.3%) had a history of previous cardiovascular events, ten patients (11.6%) were smokers and two patients (2.3%) ex smokers. Ten patients (11.8%) had a concomitant diagnosis of diabetes, thirty patients (34.9%) had hypertension, two (6.9%) hyperuricemia, thirteen patients (36.1%) had dyslipidemia, three patients (3.5%) had recurrent infections and five patients (5.8%) had a family history of neoplasm. No patients had a history of thromboembolism and four patients (4.6%) had previous events of herpes zoster (HZ), only 6 patients receveid vaccine anti-HZ virus. Twenty-five patients (71.4%) had a positivity for rheumatoid factor (RF) and twenty-two (61.6%) were positive to anti-citrullinated protein antibodies (ACPA). Ninenty-three percent of patients were previously treated with at least one bDMARDs and only one patient with another tsDMARD. During the follow-up, four patients discontinued UPA for lack of efficacy (n=1) or for adverse events (n=3).

Results. We observed a significant reduction of pain, number of tender/swollen joints and a significant reduction of inflammatory parameters was observed at T3, T6, T12 and T24. A significant percentage of patients reached remission (DAS28, CDAI and SDAI) at T3 and a significant steroid-sparing was observed at T3. This Calabrian cohort is a picture on the use of UPA in clinical practice including 87 patients. Among these, 53 patients (60.9%) had at least one risk factors identified by EMA and almost all patients showed an inadeguate response to bDMARDs. Only six patients were vaccinated for HZ. Although this cohort was at high risk to develop HZ and MACE, only 4 patients discontinued therapy for adverse events, no CV events were observed. At T24, only two patients developed a Zoster infection.

Conclusions. Our data confirmed the good safety profile of UPA reported in RCT and in RWE studies. Regarding efficacy, these results confirmed data reported in RCT on the reduction of pain, inflammation and in the improvement of clinical parameters, especially in the so-called difficult-to-treat patients.