Ab1125 treatment with upadacinitib in refractory psoriatic arthritis. multicenter study of 101 patients of clinical practice

Background Upadacitinib (UPA) is an inhibitor of JAK kinases recently approved by EMA for the treatment of psoriatic arthritis (PsA) in Europe (January 2021) [1] UPA has shown efficacy in refractory patients to anti-TNF [2] Objectives A ) to assess efficacy and safety of UPA in the first cases in Spain in clinical practice. B ) to compare the profile of clinical practice (CP) patients with clinical trial (CT) of UPA in PsA refractory to biologics [2] Methods Study of 101 patients of CP with PsA treated with UPA in Spain. The diagnosis of PsA was made using CASPAR criteria. Patients who received one or more dose of UPA with at least one follow-up visit were included. Results are expressed as percentage, mean±SD or median [IRQ] Results 101 patients (73♀/28♂), mean age of 43.8 ± 12.1 years (Table 1). Pattern joint involvement was: peripheral (n=61) axial (8) and mixed (32) During the PsA evolution patients presented enthesitis (38.6%) nail involvement (22%) and dactylitis (25.7%) Prior to UPA most patients (71.3%) received oral prednisone or equivalent (mean maximum dose 12.04±6.98 mg/d), synthetic immunosuppressants (mean; 1.8±0.9) and biological therapy (TB) (3.4±2.2). TB were: etanercept (n=47), adalimumab (77), infliximab (23), golimumab (21), certolizumab (32), secukinumab (53), ixekizumab (32), ustekinumab (34), Abatacept [2], brodalumab [1] and guselkumab [2]. Apremilast was used in 23, Tofacitinib in 26 and filgotinib in 1 UPA was started (15 mg/24 h) after a mean follow-up of 9.9±7.8 years from PsA diagnosis. Prednisone was used in 47 cases (mean dose, 7.8±5.7 mg/d). UPA was combined with methotrexate (n=30), salazopyrin (7) and leflunomide (15); in the remaining 51 cases (50.50%) was used in monotherapy. At UPA initiation patients presented peripheral arthritis (78%), axial involvement (28,71%), skin involvement (22.8%), enthesitis (22.7%), and dactylitis (11%) Patients of CP compared with CT were younger, more frequently women, refractory to a greater number of TB and received more concomitant corticosteroid (Table 1 ) After a median follow-up of 5.72±4.64 months with UPA, patients showed a prompt improvement in activity indexes (DAS28, DAPSA) (Figure 1 ) and CRP mg/L decreased from a median 2.51 [1.0-8.0] to 1.00 [0.30-5.00] (p <0.006). Extra-articular manifestations also improved: dactylitis in 75% patients, enthesitis (55.56%) and skin involvement (60%) No serious Adverse events (AE) were reported. Minor side effects were observed in 20 patients (19.8%). UPA was discontinued in 31 (20 inefficiency, 4 patient decision, 2 infection, 2 thrombosis, 1 surgery, 1 pregnancy) Conclusion In this study, first patients of CP in Spain with UPA in PsA were younger, received concomitant corticosteroid more frequently and were refractory to a greater number of TB than those of CP. As in the UPA CT, it seems effective, rapid and relatively safe in daily CP for refractory Ps.A. References [1] https://www.ema.europa.eu/en [2]Mease PJ et al. Ann Rheum Dis 2021; 80 :312–320 Table 1. CLINICAL PRACTICE N=101 CLINICAL TRIAL N=211 p Baseline demographic parameters Age years (mean±SD) 43.8±12.1 53.0 ± 12.0 <0.001 Sex n (%) female 73 (72.3) 113 (53.6) 0.002 Disease Characteristics Duration of PsA year (mean±SD) 9.94 ± 7.8 9.5 ± 8.4 0.658 HAQ-DI 0.97±0.65 1.10 ± 0.6 0.082 Swollen joint count mean±SD 4.33 ± 5.01 11.3 ± 8.2 <0.001 Painful joint count mean±SD 6.15 ± 5.68 24.9 ± 17.3 <0.001 Enthesitis n (%) 23 (22.7) MASES 172 (81.5) SPARCC <0.001 Dactylitis n (%) 11 (11) 55(26.1) 0.001 PASI score mean±SD 0.95±1.64 10.1 ± 9.2 <0.001 CRP (mg/L) 8.72 ± 15.50 11.2 ± 18.5 0.245 Oral glucocorticoid use n (%) 47 (46.53) 22 (10.4) <0.001 Concomitant synthetic DMARDs n (%) 50 (49.50) 98 (46,4) 0.613 Previous use of biological DMARDs n (%) 94 (93.1) 195 (92.4) 0.837 Number of prior failed biologic DMARDs n (%) 1 16 (15,84) 135 (63.7) <0.001 2 18 (17.82) 35 (16.5) 0.786 ≥3 60 (59.40) 24 (11.3) <0.001 UPA in monotherapy n (%) 51 (50.50) 113 (53.6) 0.613 HAQ-DI Health Assessment Questionnaire-Disability Index, PASI Psoriasis Area Severity Index, CRP C-reactive protein, DMARD disease-modifying antirheumatic drug Figure 1. Acknowledgements: NIL. Disclosure of Interests None Declared.