Upadacitinib monotherapy or in combination with methotrexate (MTX) is effective in causing disease remission or reduced disease activity (LDA) in patients with rheumatoid arthritis (RA), according to a recent study published in It was related. Clinical and experimental rheumatology.
Woman sitting with rheumatoid arthritis | Photo Woman sitting with rheumatoid arthritis Image credit: Valentina – Stock.adobe.com
Currently, typical treatments for rheumatoid arthritis include conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). However, these drugs become less effective as a patient’s disease progresses, and in many cases targeted synthetic DMARDs such as biological DMARDs (bDMARDs) or Janus kinase (JAK) inhibitors are used to induce disease remission or LDA. (tsDMARD) is required.
Even with the addition of these drugs, not all patients respond adequately to DMARDs. In such cases, Germany has shown that upadacitinib, a selective and reversible JAK inhibitor, is effective in treating adults with moderate to severe RA who have not responded to one or more of their DMARDs. Proven.
The use of upadacitinib was reinforced by the results of the SELECT-NEXT Phase 3 trial. In this study, upadacitinib resulted in disease remission in patients regardless of C-reactive protein (CRP) levels. As the authors of this study point out, CRP levels are typically important markers of disease activity, and clinical trials often enroll patients with elevated CRP levels, thus requiring specific requirements. Many patients who do not meet the criteria will be excluded. Expanding research into drugs that are effective regardless of CRP levels could increase access to treatment for patients, including through clinical trials, the researchers added.
Actual evidence regarding patients with active disease who do not have elevated CRP levels is lacking. To further advance the clinical understanding of these patients, researchers demonstrated that the efficacy of upadacitinib (as monotherapy or dual therapy with MTX (csDMARD)) is influenced by baseline CRP levels in the treatment of RA. We conducted a prospective, non-interventional, real-world study to find out. .
Data from 518 patients from 50 rheumatology outpatient clinics and office-based rheumatologists in Germany were enrolled between February 6, 2020 and February 1, 2022. They were then assigned to receive either upadacitinib monotherapy (n = 260) or upadacitinib plus MTX (n = 260). = 273). Patients received upadacitinib 15 mg once daily and were followed for up to 12 months.
The primary endpoint of this study was the achievement of clinical remission (clinical disease activity index). [CDAI] ≤2.8). Secondary endpoints included simple disease activity index (SDAI) score ≤3.3, 28-joint disease activity scale (DAS28) for CRP (DAS28-CRP) or erythrocyte sedimentation rate (ESR; DAS28-ESR) score <2.6; or reaching the following conditions: LDA values (CDAI ≤ 10 or SDAI ≤ 11; DAS28-CRP ≤ 3.2 or DAS28-ESR ≤ 3.2).
Patients who completed at least one follow-up were classified as the intention-to-treat (ITT) population (n = 431). At 6 months, 24.4% (105 patients) of the entire ITT cohort reached clinical remission. The group treated with upadacitinib monotherapy and combination therapy with MTX had a similar remission rate (23.2%). [48/207] and 25.4% [57/224], Each). At 12 months, the total proportion of patients achieving remission according to CDAI, SDAI, and DAS28-CRP criteria was 28.3% (105), 34.5% (128), and 66.3% (246). On these measurements, his LAD patient achievement rates reached 77.4% (287 patients), 76.5% (284 patients), and 81.7% (303 patients) at 12 months. These trends were similar in both treatment groups receiving upadacitinib, and baseline CRP levels were not significantly correlated with an individual’s likelihood of achieving remission. Additionally, many patients reported improvement in the pain and fatigue they experienced by the end of the study period.
The efficacy of upadacitinib was similar in the monotherapy and combination therapy groups, regardless of patients’ prior experience or response to bDMARDs. Results of this study demonstrate the efficacy of upadacitinib therapy in the treatment of RA, induction of clinical remission, and suggest that baseline CRP levels may not correlate with patient disease activity or potential response to treatment. This was supported by evidence.
reference
Witte T, Kiltz U, Haas F, et al. Effect of C-reactive protein levels on the efficacy of upadacitinib in patients with rheumatoid arthritis: his 12-month prospective non-interventional study in Germany. Clin Exp Rheumatol. Published online on November 15, 2023. doi:10.55563/clinexprheumatol/11255h
