ACR Congress Review 2019

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 ACR20/50/70, 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