ACR Congress Review 2019

Individual and composite measures of disease activity in patients with RA treated with upadacitinib or
comparators were presented by van Vollenhoven and colleagues. The analyses included patients who
were MTX naïve (SELECT-EARLY, n=947) or MTX-IR (SELECT-COMPARE, n=1629). Responses at
Week 12 were defined as ≥50% improvement in the 7 components of the ACR response criteria. In
MTX-naïve and MTX-IR patients, treatment responses at 12 weeks occurred in significantly higher
proportions of patients receiving upadacitinib monotherapy versus MTX and upadacitinib plus MTX
versus placebo for all 7 components of the ACR response criteria, and for 5 of 7 ACR components for
upadacitinib plus MTX versus adalimumab plus MTX. Favourable outcomes with upadacitinib treatment
were evident both in composite and individual parameters [523].
Kremer and colleagues presented the comparative efficacy of upadacitinib in combination with MTX
versus upadacitinib in combination with other csDMARDs. Analyses were performed using data from the
SELECT-NEXT and SELECT-BEYOND trials, in which 535 and 410 patients, respectively, received
concomitant MTX (mean dose 17 mg/week), and 124 and 82 patients received non-MTX csDMARDs.
Across all subgroups, the proportion of patients achieving efficacy outcomes was higher with both
upadacitinib doses compared with placebo. There were no significant differences between efficacy
outcomes with upadacitinib in combination with MTX versus upadacitinib in combination with non-MTX
csDMARDs in either patient population; this included ACR20 response as well as LDA and remission
defined by DAS28-CRP and CDAI. In summary, the efficacy of upadacitinib in patients with RA
appeared comparable whether administered in combination with MTX or non-MTX csDMARDs [524*].
Hall and colleagues presented remission rates in patients with RA treated with upadacitinib or
comparators. The analyses included patients who were MTX naïve (SELECT-EARLY, n=945), MTX-IR
(SELECT-COMPARE, n=1629) and bDMARD-IR (SELECT-BEYOND, n=498). At 12 weeks, in
SELECT-EARLY and SELECT-COMPARE, a significantly greater proportion of patients receiving
upadacitinib 15 or 30 mg QD achieved remission by all four definitions versus MTX, placebo or
adalimumab. In SELECT-BEYOND, (a refractory population many of whom had an inadequate response
to multiple bDMARDs), a significantly greater proportion of patients receiving upadacitinib 30 mg
achieved all remission definitions versus placebo within the first 12 weeks and rates of remission further
increased through Week 24 for both dose groups. All disease activity components of each remission
definition were significantly improved in patients receiving upadacitinib compared to MTX or placebo,
and all Boolean components were significantly improved in patients receiving upadacitinib 15 mg
compared with adalimumab [529].
An evaluation of structural joint damage progression through Week 48 in patients with moderately to
severely active RA treated with upadacitinib monotherapy or in combination with MTX was presented by
Peterfy and colleagues. The analysis included patients from SELECT-EARLY (n=945) and
SELECT-COMPARE (n=1629). At Weeks 24/26, upadacitinib as monotherapy and in combination with
background MTX significantly inhibited radiographic progression (measured by mean ΔmTSS) and the
proportion of patients with no radiographic progression versus MTX and placebo, respectively. The
significant inhibition of radiographic progression with upadacitinib was maintained through Week 48
versus MTX in SELECT-EARLY and versus placebo in SELECT-COMPARE. Following the switch of all
placebo patients to upadacitinib in SELECT-COMPARE by Week 26, no further change in mean mTSS
was observed through Week 48. In summary, upadacitinib both as monotherapy, and 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, respectively [547*].
Fleischmann and colleagues presented outcomes associated with a treatment switch from upadacitinib
to adalimumab and vice-versa among MTX-IR RA patients who were non-responders or partial
responders in a Phase 3 study of upadacitinib 15 mg QD versus placebo or adalimumab 40 mg injection
EOW. Of the 651 and 327 patients randomised to receive upadacitinib and adalimumab, 39% were
switched from upadacitinib to adalimumab and 49% were switched from adalimumab to upadacitinib.
*Chairman’s Pick