ACR Congress Review 2019

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1114 patients were included, of whom 648 received monotherapy in SELECT-MONOTHERAPY and 466 received combination therapy in SELECT-NEXT. In these cohorts of patients with RA and an inadequate response to MTX, both upadacitinib monotherapy and upadacitinib combination therapy led to significant improvements in efficacy outcomes versus continued MTX or placebo plus MTX. No significant differences were observed between upadacitinib monotherapy and upadacitinib combination therapy across a range of clinical endpoints including ACR20/50/70 responses and measures of LDA and remission. In addition, improvements in quality of life as measured by HAQ-DI were similar with upadacitinib monotherapy and combination therapy. The authors concluded that in MTX-IR RA patients, the efficacy of upadacitinib appears comparable when administered as monotherapy or when given in combination with MTX [511*]. Kapetanovic and colleagues presented a post-hoc analysis of the SELECT-EARLY study results to examine the effect of receiving upadacitinib treatment within 3 months of treatment. A total of 270 patients started treatment within 90 days from RA diagnosis (median: 44 days). At Week 24, compared to MTX, significantly greater proportions of patients receiving upadacitinib 15 or 30 mg monotherapy achieved efficacy outcomes including ACR20, 50 and 70 responses, DAS28CRP
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
Page 1 and 2: Enhancing knowledge of the clinical
Page 3 and 4: Highlights from ACR 2019 During the
Page 5 and 6: In summary, individually, high base
Page 7: treatment with MTX. A total of 1629
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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