Upadacitinib (UPA) is approved for moderate-to-severe rheumatoid arthritis (RA) based on SELECT trials, but data on real-world effectiveness are limited. UPHOLD is a multicountry study of patients with RA receiving UPA 15 mg. The present interim analysis was based on the Italian cohort performed across 28 centers. Co-primary endpoints were (i) the proportion of patients receiving UPA who achieved DAS28(CRP) remission (< 2.6) at 6 months and (ii) the proportion of patients achieving DAS28(CRP) remission at 6 months who continued to receive UPA and maintained remission (or had no more than a 0.6-point increase in DAS28[CRP]) at 12 months, analyzed by modified non-responder imputation (mNRI) and as observed (AO). Modified full analysis sets (mFAS1 and mFAS2) included patients completing 6 and 12 months, respectively. Safety analysis included reporting of adverse events and treatment-emergent adverse events (TEAEs), as exposure-adjusted event rates (EAERs; events per 100 patient-years [E/100PY]). Among 270 patients, 74 (27.4%) discontinued by 12 months because of lack of efficacy (13.7%) or adverse events (8.1%). In mFAS1 (N = 168), 50.6% (mNRI) and 62% (AO) achieved DAS28(CRP) remission at 6 months. In mFAS2 (N = 55), 80% (mNRI) and 91.7% (AO) maintained DAS28(CRP) remission at 12 months. CDAI and SDAI remission rates at 12 months were 31.3%. Patients on UPA monotherapy at 12 months showed remission rates of 49.5% (DAS28[CRP]), 27.2% (CDAI), and 27.4% (SDAI). Significant improvements in patient-reported pain and physical function were also observed. A total of 278 TEAEs were reported (80.8 E/100PY), including herpes zoster, liver disorders, and serious infections with EAERs of 2.0, 1.5, and 1.2 E/100PY, respectively. UPA 15 mg was observed to effectively treat moderate-to-severe RA in the real-world setting, with ≥ 80% maintaining DAS28(CRP) remission at 12 months, showing a favorable benefit-risk profile. ClinicalTrials.gov identifier, NCT04497597. Rheumatoid arthritis is a chronic autoimmune disease that causes joint pain, swelling, and disability. Although several effective treatments exist, many people with rheumatoid arthritis still struggle to achieve remission and fully control their symptoms. Upadacitinib is a once-daily oral treatment that has shown strong results in clinical trials, but less is known about how well it works in everyday medical practice.This study followed 270 people with moderate-to-severe rheumatoid arthritis who began treatment with upadacitinib across 28 centers in Italy. Rheumatologists monitored their disease activity, pain, physical function, and any side effects over 12 months. After 6 months of treatment, about half of the patients had achieved remission according to a commonly used disease activity measure (DAS28-CRP). After 1 year, more than 80% of those who reached remission were able to maintain it. Other measures of disease control (CDAI and SDAI) also improved, and many patients reported less pain and better ability to perform daily activities. Upadacitinib was seen to be effective both when used alone and when combined with other standard rheumatoid arthritis medications.Side effects were generally consistent with what has been seen in clinical trials, with low rates of serious infections, liver issues, or blood clots, and no major cardiovascular events recorded.Overall, this real-world study shows that upadacitinib is an effective and well-tolerated option for helping people with rheumatoid arthritis achieve and sustain meaningful improvements in symptoms and quality of life.
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