AB0911 Short-term results of guselkumab efficacy for psoriatic arthritis in real life.

Abstract

BackgroundPsoriatic arthritis is a chronic immune-mediated disease that mainly affect joints, but is associated with a significant increase in cardiovascular risk and other comorbidities. In the last decades, some pathogenic pathways of these diseases have been identified and have led to the development of new therapeutic strategies such as biologic drugs. Early treatment and treat-to-target strategies have achieved a great improvement in the management of the disease, but there are still many refractory cases and further research is needed.Guselkumab is a human IgG1λ monoclonal antibody that selectively binds to interleukin 23, a regulatory cytokine that affects the activity of T lymphocyte subsets. In this way, blockade of IL-23 normalizes the production of pro-inflammatory cytokines. Guselkumab was approved by FDA to psoriatic arthritis treatment in 2020.ObjectivesTo analyze the real-life effectiveness of guselkumab in a cohort of patients with psoriatic arthritis.MethodsA prospective observational study was conducted in psoriatic arthritis patients who received treatment with guselkumab in a hospital center in the southeastern area of Spain, from April 2020. Patient demographic and baseline data were recorded and response variables such as DAPSA index, presence of enthesitis and dactylitis, skin affection by BSA, and drug persistence at 12 and 24 weeks of treatment were analyzed. In addition, adverse events were recorded.ResultsTwenty-nine psoriatic arthritis patients, 20 women, mean age at entry 52 ± 2.47 years, were included in this analysis. The mean of years since psoriatic arthritis diagnosis was 10.14 ± 1.68 years. Demographic and baseline variables of the patients are detailed in Table 1.Table 1.Demographics and baseline patient characteristics.Baseline Patient Characteristicsguselkumab100 mg/8 W(n = 29)Age at inclusion, mean (95% CI), years52 ± 2.47Sex Female, n (%)20, 68.9 % Male, n (%)9, 31.1 %Disease duration of PsA mean [95% CI], years10.14 ± 1.68DAPSA mean [95% CI]25.02 ± 2.44Enthesitis, n (%)11, (37.93 %)Dactylitis, n (%)BSA mean [95% CI]3, (10.34 %)Line of treatment12.54 ± 5.94 Second, n (%)2, (6.89 %) Third, n (%)8, (27.58 %) Fourth, n (%)8, (27.58 %) Fifth, n (%)2, (6.89 %) Sixthh, n (%)3, (10.34 %) Seventh, n (%)5, (17.24 %) Eighth, n (%)1, (3.44 %)The mean DAPSA value at the start of treatment was 25.02 ± 2.446. After 12 weeks, it was 17.51 ± 2.855, and after 24 weeks of treatment, it had dropped to 12.37 ± 3.547 points, this difference was statistically significant with p<0.01. The percentage of enthesitis presented a significant reduction, from 37.93% at baseline to 3.84% at 24 weeks of treatment. BSA index had a mean of 12.54 ± 5.94 at baseline, with a significant reduction at 12 weeks (2.136 ± 1.214) and at 24 weeks (0.4167 ± 0.4167).According to their DAPSA index score, patients were classified into remission, low activity disease, and active disease categories. One third of patients achieved complete remission, and another third achieved low disease activity at 24 weeks, as reflected in Figure 1.Figure 1.Percentage of patients reaching remission (REM), low disease activity (LDA) or active disease at baseline, 12 and 24 weeks after guselkumab treatment.Treatment persistence was 89.65% at both 12- and 24-week reviews, as only 3 patients dropped out of treatment at 12 weeks. No drug-related adverse events, including local injection site reactions, were recorded.ConclusionGuselkumab is effective and safe for the manifestations of psoriatic arthritis in a real-life cohort of patients.