ACR Congress Review 2019

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Suppression of joint destruction with peficitinib A secondary analysis evaluating the suppression of join destruction with peficitinib was presented by Takeuchi and colleagues. This Phase 3 trial (NCT02305849) examined the efficacy and safety of a peficitinib-MTX combination in patients with RA who had an inadequate response to MTX. A total of 518 patients were included in the analysis: placebo (n=170), peficitinib 100 mg/day (n=174) and peficitinib 150 mg/day (n=174). Sensitivity analyses showed that the change in mTSS at Week 28 was similar to the primary analysis result, demonstrating the robustness of the primary analysis. At Week 28, a significantly greater proportion of patients achieved a change in mTSS of ≤0.5 with both peficitinib 100 and 150 mg/day compared with placebo (67.1% and 72.6% versus 45.8%, respectively; P
treatment with MTX. A total of 1629 patients were randomised to upadacitinib 15 mg QD, placebo, or adalimumab 40 mg EOW, while continuing stable background MTX. Rescue therapy was offered based on predefined clinical criteria at Weeks 14 to 26 and all patients receiving placebo who were not rescued were switched to upadacitinib at Week 26. Between Weeks 14 and 26, 38.7% of patients randomised to upadacitinib and 48.6% of patients randomised to adalimumab were rescued. At Week 26, and Week 48, significantly more patients in the upadacitinib versus adalimumab group achieved <strong>ACR</strong>20/50/70, low disease activity and remission; this was also true for visits between Weeks 26 and 48. Similarly, improvements in pain and function were significantly greater in the upadacitinib versus adalimumab group through Week 48. At Week 26, there was significantly less radiographic progression for upadacitinib versus placebo, which was maintained through Week 48 based on linear extrapolation. Safety was consistent with observations in the first 26 weeks. The rate of AEs leading to discontinuation was higher with “any adalimumab” versus “any upadacitinib”, while the rate of herpes zoster was higher with “any upadacitinib” exposure. In summary, upadacitinib continued to demonstrate superior clinical and functional responses compared with adalimumab through Week 48 [527]. Sixty-week results from the ongoing extension of the Phase 3 SELECT-NEXT study were presented by Burmester and colleagues. In SELECT-NEXT, patients with moderately-to-severely active RA and an inadequate response to csDMARDs received once-daily upadacitinib 15 mg, upadacitinib 30 mg or placebo for 12 weeks on stable background csDMARDs. At Week 12, the start of the long-term blinded extension, patients initially randomised to placebo were switched to upadacitinib 15 mg or 30 mg per pre-specified assignment at baseline. Patients initially assigned to upadacitinib continued their assigned dose; no dose adjustments were permitted, but adjustments to background RA medications were permitted from Week 24. Ninety-two percent of patients completed Week 12 and continued onto the extension. Based on an “As Observed” analysis, for patients who continued on upadacitinib 15 mg (85%) and upadacitinib 30 mg (81%), clinical and functional outcomes continued to improve or were maintained through Week 60, with 59% and 56% of patients in these groups achieving DAS28-CRP
Page 1 and 2: Enhancing knowledge of the clinical
Page 3 and 4: Highlights from ACR 2019 During the
Page 5: In summary, individually, high base
Page 9 and 10: Individual and composite measures o
Page 11 and 12: Upadacitinib in axial spondylarthri
Page 13 and 14: Safety, efficacy and PROs with a to
Page 15 and 16: Impact of BMI on tofacitinib safety
Page 17 and 18: Patient-reported outcomes with JAK
Page 19 and 20: Update on JAK inhibitor safety data
Page 21 and 22: In the first presentation, the anal
Page 23 and 24: References Bergman M, Tanaka Y, Cit
Page 25 and 26: Kremer J, Van den Bosch F, Rubbert-

ACR Congress Review 2019

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