Journal Article

AB1120 REAL-LIFE EFFICACY AND SAFETY OF IXEKIZUMAB IN A COHORT OF PATIENTS WITH PSORIATIC ARTHRITIS: A SINGLE-CENTER RETROSPECTIVE STUDY

Lomater, C., Donzella, D., Guardo, V., Crepaldi, G., Saracco, M., Marucco, E., Gammino, M., Bellis, E., Data, V., Iagnocco, A.

2023

Overview

BackgroundIxekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A and is indicated for psoriasis, psoriatic arthritis (PsA) and axial spondyloarthritis.Literature highlights efficacy and safety in real life in patients affected by psoriasis[1], instead little are data concerning PsA.[2]ObjectivesTo retrospectively evaluate the effectiveness and safety of ixekizumab, in a cohort of patients with PsA.MethodsPatients with a diagnosis of PsA and treated with ixekizumab who visited our outpatient clinic from October 2019 to December 2022 were included in the study. Clinical data were recorded since the first prescription of ixekizumab and at 6-month follow-up visit. Demographic, clinical and laboratory characteristics, treatment, and causes of discontinuation were analyzed. Differences between baseline and 6-months erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), tender joint count (TJC) and swollen joint count (SJC) were analysed.ResultsMain results are reported on Table 1. 76 patients were included in the study, with an average age at the prescription of ixekizumab (T0) of 57.1±13.0 years.Main comorbidities were: hypertension (44.7%), obesity and overweight (44.7%), cardiopathy (19.7%), hepatic steatosis (21.0%), diabetes (13.2%), and hyperlipemia (3.9%). 93.42% of patients presented peripheral arthritis, 30.6% axial involvement, and 42.1 % enthesitis.28,9% of patients were biologic-naïve, 34,0% received one biologic agent before, and 31.5% two or more biologic agents. 88,2% of patients initiated ixekizumab in combination with a csDMARDs, mainly methotrexate.The indications for the prescription of ixekizumab as a first biologic agent were: multiple comorbidities, severe psoriasis, and intolerance to csDMARDs.28.9% of patients stopped ixekizumab because of primary failure (31.8%), secondary failure (22.7%), or adverse events (45.5%). 40% of the adverse events were relevant skin reactions at the injection site. No severe adverse events were registered.60 patients completed 6 months of treatment (T6). In those patients, a statistically significant decrease between the SJC and TJC at baseline and T6 was found (p-value 0.0011 and 0.0006 respectively). No difference in the values of ESR and CRP values between T0 and T6 was present.ConclusionThere are few data in real life concerning efficacy and safety in patients affected by PsA. In our cohort, ixekizumab significantly improved peripheral arthritis, and it revealed a good safety profile, without severe adverse events during the follow up. Further real-life evaluations on axial involvement, which was not included in this study, are warranted.References[1]Malagoli P. et al. Real life long-term efficacy and safety of ixekizumab in moderate-to-severe psoriasis: A 192 weeks multicentric retrospective study-IL PSO (Italian landscape psoriasis). Dermatol Ther. 2022[2]Manfreda V. et al. Efficacy and safety of ixekizumab in psoriatic arthritis: a retrospective, single-centre, observational study in a real-life clinical setting. Clin Exp Rheumatol. 2020Table 1.General characteristics of our cohort and clinical and laboratory findings at baseline and follow-up for patients who completed 6 months of treatment with ixekizumab.Male/female n. (%)22 (28.9%)/54 (71.1%)Mean age at diagnosis (years)50.0Years from diagnosis at the first prescription of ixekizumab (years)6.7Patients: n. 60T0T6p-valueESR (mm/h)27.44±23.327.56±22.20.9741CRP (mg/dl)1.58±2.470.98±1.70.1569TJC9.17±6.985.02±6.650.0011SJC1.57±2.750.28±0.640.0006Acknowledgements:NIL.Disclosure of InterestsElisa Bellis Consultant of: Bristol-myers Squibb Srl - Temas, Grant/research support from: Pfizer, DENISE DONZELLA: None declared, Gloria Crepaldi Speakers bureau: Eli-Lilly, BMS, Consultant of: Galapagos, Janssen, Valeria Data: None declared, Marinella Gammino: None declared, Valeria Guardo: None declared, Claudia Lomater Speakers bureau: Eli-Lilly, Janssen, Formedica, Bristol-myers, Elena Marucco: None declared, Marta Saracco: None declared, Annamaria Iagnocco Speakers bureau: Abbvie, MSD, Alfasigma, Celltrion, BMS, Celgene, Eli-Lilly, -Sanofi Genzyme, Pfizer, Galapagos, Gilead, Novartis, SOBI, Janssen, Consultant of: Abbvie, MSD, Alfasigma, Celltrion, BMS, Celgene, Eli-Lilly, -Sanofi Genzyme, Pfizer, Galapagos, Gilead, Novartis, SOBI, Janssen, Grant/research support from: Pfizer, Abbvie.

• Publisher: BMJ Publishing Group Ltd and European League Against Rheumatism,Elsevier B.V,Elsevier Limited
• Subject: Adverse events / bDMARD / Body weight / C-reactive protein / Comorbidity / Diabetes mellitus / Diagnosis / Erythrocyte sedimentation rate / Fatty liver / Inflammatory diseases / Intolerance / Laboratories / Methotrexate / Monoclonal antibodies / Overweight / Patients / Psoriasis / Psoriatic arthritis / Real-world evidence / Rheumatic diseases / Safety / Scientific Abstracts / Statistical analysis / Steatosis