Ab1125 treatment With Upadacinitib in Refractory Psoriatic Arthritis. Multicenter Study of 101 Patients of Clinical Practice

Abstract

BackgroundUpadacitinib (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]ObjectivesA) 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]MethodsStudy 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]Results101 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 1UPA 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)ConclusionIn 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;80:312–320Table 1.CLINICAL PRACTICE N=101CLINICAL TRIAL N=211pBaseline demographic parametersAge years (mean±SD)43.8±12.153.0 ± 12.0<0.001Sex n (%) female73 (72.3)113 (53.6)0.002Disease CharacteristicsDuration of PsA year (mean±SD)9.94 ± 7.89.5 ± 8.40.658HAQ-DI0.97±0.651.10 ± 0.60.082Swollen joint count mean±SD4.33 ± 5.0111.3 ± 8.2<0.001Painful joint count mean±SD6.15 ± 5.6824.9 ± 17.3<0.001Enthesitis n (%)23 (22.7) MASES172 (81.5) SPARCC<0.001Dactylitis n (%)11 (11)55(26.1)0.001PASI score mean±SD0.95±1.6410.1 ± 9.2<0.001CRP (mg/L)8.72 ± 15.5011.2 ± 18.50.245Oral glucocorticoid use n (%)47 (46.53)22 (10.4)<0.001Concomitant synthetic DMARDs n (%)50 (49.50)98 (46,4)0.613Previous use of biological DMARDs n (%)94 (93.1)195 (92.4)0.837Number of prior failed biologic DMARDs n (%)116 (15,84)135 (63.7)<0.001218 (17.82)35 (16.5)0.786≥360 (59.40)24 (11.3)<0.001UPA in monotherapy n (%)51 (50.50)113 (53.6)0.613HAQ-DI Health Assessment Questionnaire-Disability Index, PASI Psoriasis Area Severity Index, CRP C-reactive protein, DMARD disease-modifying antirheumatic drugFigure 1.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

Difficult-to-treat psoriatic arthritis (D2T PsA): a scoping literature review informing a GRAPPA research project

“…26 27 Only one study included patients with prior corticosteroid use as part of the definition of D2T. 20 The review by Lubrano et al 11 was distinct, being the only study that proposed dividing into refractory disease secondary to persistent inflammation ('refractory to treatment' PsA) and non-remission due to pre-existing comorbidities ('D2T' PsA). 11 In terms of nomenclature, the reviewed studies employed a variety of terms for cases with an inadequate treatment response.…”