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Inhibition of structural joint damage progression with upadacitinib in rheumatoid arthritis: 1-year outcomes from the SELECT phase 3 program. | LitMetric

AI Article Synopsis

  • The study aimed to evaluate the effectiveness of upadacitinib, given alone or with methotrexate (MTX), in slowing the progression of joint damage in patients with active rheumatoid arthritis (RA) over 48 weeks.
  • Researchers conducted two phase 3 trials, comparing upadacitinib with MTX and other treatments in different patient groups.
  • Results showed that upadacitinib significantly reduced joint damage compared to MTX alone, indicating its potential as an effective treatment for both MTX-naïve patients and those with inadequate response to MTX.

Article Abstract

Objectives: To evaluate the inhibition of progression of structural joint damage through week 48 in patients with moderately to severely active RA receiving upadacitinib as monotherapy or in combination with MTX.

Methods: Radiographic progression was assessed in two phase 3 randomized controlled trials. MTX-naïve patients were randomized to upadacitinib 15 or 30 mg once daily or MTX monotherapy (SELECT-EARLY, n = 945), while MTX inadequate responders (IRs) were randomized to upadacitinib 15 mg once daily or adalimumab 40 mg every other week or placebo added to background MTX (SELECT-COMPARE, n = 1629). The mean changes from baseline in modified total Sharp score (mTSS), joint space narrowing and erosion scores were determined. Data were analysed both by linear extrapolation for missing data imputation and treatment switching and as observed.

Results: In patients naïve or with limited exposure to MTX (SELECT-EARLY), mean changes from baseline to week 48 in mTSS were 0.03 for upadacitinib 15 mg, 0.14 for upadacitinib 30 mg and 1.00 for MTX based on linear extrapolation (P < 0.001 for both upadacitinib doses vs MTX). Among patients with an inadequate response to MTX (SELECT-COMPARE), the mean change from baseline in mTSS was significantly reduced in the upadacitinib 15 mg plus MTX group vs placebo plus MTX (0.28 vs 1.73; P < 0.001). The mean change from baseline in the adalimumab plus MTX group was 0.39.

Conclusion: Upadacitinib monotherapy or in combination with background MTX was effective in inhibiting the progression of structural joint damage through week 48 in MTX-naïve and MTX-IR patients with RA.

Trial Registration: ClinicalTrials.gov (https://clinicaltrials.gov), NCT02706873 and NCT02629159.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9348768PMC
http://dx.doi.org/10.1093/rheumatology/keab861DOI Listing

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