Background: Ustekinumab (UST) is an anti- interleukin (IL) 12/23 monoclonal antibody that has been shown to be effective and safe in psoriatic arthritis (PsA) in two phases III clinical trials. However, we have very few UST data in a real- life setting.
Objectives: To assess the effectiveness, safety and survival of UST among patients with PsA treated under routine clinical care.
Methods: Retrospective and multicentric study. Epidemiological and clinical data were collected through the electronic medical record of all patients with PsA who started UST due to rheumatological indication in 14 hospitals of Catalonia and the Balearic Islands (Spain).
Results: 152 patients were included, 116 (76.3%) with 45mg and 36 (23.8%) with 90mg. 55.9% were women, mean age 54.79 (12.5) years, and mean disease duration 209 months. 132 patients (87%) had oligo (30.3%) or polyarticular involvement (56.6%). 26.8% had enthesitis and 36.2% dactylitis. 48p(35.6%) had erosions. 94p (61.8%) had previously received another biological therapy, and 39 of them (38.8%) had received 2 or more. 54.6% of the patients were taking DMARDs and 39.5% glucocorticoids. The baseline DAS 28 was 3.97 (1.45), C reactive protein (CRP) was 2 mg/dl (2), SJC was 4.0 (5.4), and PASI was 6.5 (8.4). There were no significant differences in clinical and epidemiological data between patients at 45 or 90 mg except in obese patients (58.4% in 90mg vs 40% in 45mg, p = 0.038). Overall, there was a significant decrease in DAS28, SJC, TJC and PASI in the first month of treatment, with more pronounced improvement in skin (PASI and BSA) than in joints outcomes, where the curves reached a plateau at 6 months. There were no significant differences between joint and/or skin outcomes between 45 and 90 mg doses.
Patients naive to biological therapy had an earlier skin improvement than patients with previous biological failure. Likewise, the improvement in joint outcomes was also faster in naive vs biological experienced patients (DAS28 and SJC 4m, p = 0.01 and 0.01, respectively).
After an average of 19m of follow-up, 94 out of 152p (61.8%) continued with UST, 54.4% started at 45mg and 72.2% at 90mg (p = 0.04). 42p (28.2%) stopped UST due to joint inefficacy, 8p (5.4%) for skin inefficacy and 4 (2.7%) for adverse effect. Although survival was better in patients with fewer previous biological agents, no significant differences were achieved (p = 0.233 for naive and p = 0.072 for patients with 1 biological failure).
Conclusion: This analysis demonstrates that UST, administered to PsA patients in a routine clinical care setting, is safe and effective in improving skin and joint outcomes. 61.2% of the patients continued with the treatment after an average of 19m of follow-up. Joint and skin outcomes reached significant differences from the first month. The efficacy seems faster in those patients with fewer lines of previous biological therapies. One third of the patients interrupted the therapy due to joint inefficacy.
Disclosure of interests: Ana Belén azuaga-Piñango: None declared, Beatriz Frade-Sosa: None declared, ana Laiz Consultant for: Lilly, Novartis, abbVvie, MSD, UCB and Janssen, Speakers bureau: Lilly, Novartis, abvvie, MSD, UCB and Janssen, Paula Estrada: None declared, Luciano Polino: None declared, Emma Beltrán: None declared, Águeda Prior-Español: None declared, Lourdes Mateo Soria: None declared, Carme Moragues Pastor : None declared, agusti Sellas-Fernández: None declared, aNA URRUTICOECHEA-ARANA: None declared, Mireia Moreno : None declared, Javier Garcia Miguel: None declared, José L Tandaipan: None declared, Manel Pujol: None declared, Vicenç Torrente Segarra : None declared, inmaculada Ros Vilamajo : None declared, Sergi Ordoñez : None declared, Delia Reina-Sanz: None declared, andrea Cuervo: None declared, Juan D. Cañete: None declared, Julio Ramirez: None declared
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