AB1119 GUSELKUMAB EFFICACY AND SAFETY ANALYSIS FOR PSA ACCORDING TO BASELINE CHARACTERISTICS AS GENDER, OBESITY OR PREVIOUS TREATMENT IN REAL LIFE AFTER 52 WEEKS

Abstract

BackgroundGuselkumab is a human IgG1λ monoclonal antibody that binds to interleukin 23, a regulatory cytokine that modifies the activity of T lymphocytes, intervening in pathogenic ways that initiate and maintain the activity of Psoriatic Arthritis (PsA). PsA has a wide spread of systemic manifestations where several profiles of disease exist depending on the predominant affection. Guselkumab has been used widely to treat cutaneous psoriatic disease (PsO) and PsA since 2020. Nevertheless, no long-term analysis have been done.ObjectivesTo analyze the long term efficacy and safety of Guselkumab at 52 weeks (w). Likewise, relevant demographic data such as sex, weight or previous biological treatment was taken into account.MethodsA prospective, unicentric, observational study was conducted in patients who met ACR criteria for PsA, who received treatment with Guselkumab for 52 w. Patient demographic and baseline data were recorded and response variables such as DAPSA and BSA index, presence of enthesitis and dactylitis, and drug persistence at 12, 24 and 52 w of treatment were statistically analyzed and compared between different groups of patients stratified by their demographic data and previous biological therapy using Student-T and ANOVA. In addition, adverse events were recorded.Results45 patients with moderate-to-severe PsA were included: 60 % were female, they had a mean BMI of 28.87. Approximately, 60% of patients received Guselkumab in fourth to eighth line of treatment.According to their DAPSA index score, patients were classified into remission, low activity and active disease. 50% of the patients fell under the remission category at w52, with the majority of the remaining in low activity (44%). The percentage of enthesitis and dactylitis presented an important reduction, from 31% and 8.88% at baseline to both 0% at 52 w respectively. BSA also experimented a significant reduction. (Figure 1)At baseline both genders showed a similar mean value for DAPSA which decreased significantly when they reached w 52. There were not differences between genders at the end of the study, however women had an earlier response with significant differences at w 12. Moreover, when we analyzed the population regarding weight, we found that Guselkumab was effective both in normal weight and also in overweight patients being 8/13 of them obese. Finally, studying the previous biologic treatment profiles, we found that better results were expected after anti-TNF or IL-17 inhibitors compared to other drugs.Treatment persistence was 100% after 24 w and 85% after 52 w in those patients who received Guselkumab as 2nd or 3rd line of treatment, but 84% and 63% at 24 and 52 w in those who took it in 4th place or more. No adverse effects were reported and a total of 11 patients abandoned treatment, 10 of them due to primary failure and 1 due to secondary failure.ConclusionGuselkumab was effective and safe for the treatment of manifestations of PsA in a real world evidence cohort of patients for 52 w. In addition, Guselkumab was equally effective in men/women as well as overweight patients, showing better results when the patient had followed treatment previously with anti-TNF or IL-17 inhibitors probably because they were less bDMARD-experienced patients. According to this fact, Guselkumab demonstrated an increased survival when administered in the second or third line of treatment compared to advanced lines of treatment.