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Background: Ustekinumab (UST) is a drug with proven efficacy in two randomized clinical trials in psoriatic arthritis -PsA- (PSUMMIT I and II). The data from these trials suggest that the 90 mg dose may be better than the 45 mg dose. Studies real world evidence (RWE) show that UST is effective and safe, nevertheless most of the evidence is base on the 45mg dose.1 Objectives: Our objective has been to check the effectiveness and safety of UST 90 mg in patients with PsA in RWE conditions. Methods: An observational study in RWE conditions was driven. We included 58 patients (37 women, 21 men, age 55 ± 8.7 years) with PsA from a single university hospital. All patients met CASPAR criteria. The observation period was from July 2017 to the present. All patients received the 90 mg dose from the beginning. The average BMI was 29.9 ± 4.41. 50% of patients were obese. To measure the disease activity, the DAPSA index was used. A descriptive statistic was performed and the McNemar test was used to analyse the mean change of the DAPSA (final-basal). A bivariate analysis was performed to identify associated factors with a DAPSA remission/low activity. Results: The duration of psoriasis was 14.8 ± 12.8 years, and 6.3 ± 6.5 years for the arthritis. 34.5% were oligoarticular forms, 13.8% polyarticular forms, and the remaining 51.7% were mixed forms. The distal interphalangeal joints synovitis was present in 38% of the patients and dactylitis in 24%. 17 patients were naive to biologic drugs (29.3%), UST was second line in 25.9%, third in 32.8%, fourth in 10.3% and fifth in 1.7% of patients. Half of the patients were treated with MTX. In the baseline situation, 9.4% had low activity, 75% had moderate activity, and 15.6% had high activity by DAPSA index. At the end of the analysis, 12.5% were in remission, 59.4% in low activity, and 28.1% in moderate activity, according to the DAPSA index. There were no patients in high activity. That is, 72% were in DAPSA remission/low activity. The average reduction of DAPSA was 9.53 ± 5.52 (McNemar’s p Conclusion: In this RWE series, UST 90 mg was effective and safe in 75% of our patients probability of achieving a remission/low activity state by DAPSA. References [1] Ustekinumab in psoriatic arthritis: need for studies from real-world evidence. Queiro R, Coto-Segura P. Expert Opin Biol ther. 2018 Sep;18(9):931-935. Disclosure of interests: None declared |
