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INTRODUCTION: Our aim was to investigate the efficacy and safety of upadacitinib (UPA) in patients with either oligo- or polyarticular active psoriatic arthritis (PsA) using routine clinical practice data from an observational, prospective, multicentre study. METHODS: This interim analysis contains upadacitinib efficacy and safety data from the UPJOINT study, collected from baseline to the week 24 visit with a focus on composite measures, clinical assessments and patient-reported outcomes, amongst others, including minimal disease activity (MDA), very low disease activity (VLDA), Disease Activity Index for Psoriatic Arthritis (DAPSA), Leeds Enthesitis Index (LEI), resolution of dactylitis and nail psoriasis and body surface area affected by skin psoriasis (BSA). RESULTS: A total of 296 patients with baseline data and 192 with completed week 24 visits were included in the analysis. The proportion of patients achieving MDA increased from 2.7% at baseline to 39.1% at week 24 (95% CI 32.1, 46.3). Similarly, the number of patients in DAPSA remission (DAPSA ≤ 4) increased from 0 at baseline to 32 (16.7%) by week 24. At that time, 59.4% of the patients were either in DAPSA remission or had low disease activity (DAPSA ≤ 14). During the 24 weeks time frame, the proportion of patients with BSA ≤ 3 increased from 80.7% to 91.1%. Furthermore, at weeks 12 and 24, 45.14% and 47.19% of affected patients showed a resolution of enthesitis. Active dactylitis and nail psoriasis at baseline were reported to affect 10.5% and 22.0%, decreasing to 2.6% and 5.7% at week 24, respectively. The safety findings are consistent with the known safety profile of upadacitinib in rheumatoid arthritis and PsA; no new safety risks were identified. CONCLUSION: The data from this study confirm the findings of previous randomized controlled trials suggesting UPA is an effective treatment for active PsA without any new safety signals in patients from daily clinical practice. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04758117.
Upadacitinib is an antirheumatic medical therapy approved for treating psoriatic arthritis with insufficient response to previous conventional or biological therapies (DMARD-IR). Psoriatic arthritis is a chronic inflammatory disease affecting the joints, spine, tendons/entheses, skin, nails and other parts of the musculoskeletal system. Early diagnosis and treatment initiation are essential for patients with psoriatic arthritis given the potentially irreversible damage to joints, spine, and entheses and the considerable impact on quality of life. The results presented in this manuscript help clinicians evaluate whether the efficacy and the safety profile of upadacitinib found in previous clinical trials can be reproduced in patients seen in daily clinical practice. This analysis presents descriptive data on the real-world efficacy and safety of upadacitinib, measured by clinical and patient-reported outcomes assessed in four visits over 24 weeks. In summary, our findings confirm the results of previous clinical trials showing that upadacitinib effectively reduces symptom severity of PsA and substantially increases the proportion of patients achieving treatment goals relevant to clinical practice, such as remission or very low disease activity. In addition, safety data were consistent with previous studies of upadacitinib in rheumatoid arthritis or psoriatic arthritis; no new risks to the patients' safety were identified.
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INTRODUCTION: Sustained remission should be considered the main therapeutic target in psoriatic arthritis (PsA). Very low disease activity (VLDA) and a DAPSA score ≤ 4 are the most commonly used criteria. The aim of the present study was to evaluate the rate of sustained remission in a group of PsA patients followed in a real-life setting. METHODS: All PsA patients satisfying CASPAR criteria were followed prospectively every 3-6 months, in a context of clinical practice by January 2013. Sustained remission was defined when patients achieved a DAPSA score ≤ 4 and/or VLDA for at least 12 months. The exclusion criterion was the presence of a condition of VLDA or DAPSA ≤ 4 at the baseline assessment. Kaplan-Meier survival curve was used to evaluate the survival of patients. RESULTS: A total of 147 PsA patients were evaluated for the study. Of these, 80 performed at least 12 consecutive months of follow-up. The average duration of follow-up was 24 months (range, 12-60 months). At the last follow-up, 22 patients were on csDMARDs treatment while 58 patients were on bDMARDs. Of the 80 patients, 14 (17.5%) achieved a sustained VLDA while 24 (30%) achieved sustained remission according to the DAPSA criteria. The mean duration of remission in patients achieving VLDA and DAPSA ≤ 4 was 17 months for both criteria. High baseline levels of CRP, shorter disease duration, and less pain at baseline were found to be predictors of sustained VLDA and DAPSA remission. CONCLUSIONS: In our study, based on clinical practice, a sustained VLDA was achieved in 17.5% and a sustained remission according to the DAPSA criteria in 30% of patients with PsA.