EULAR 2018 Review

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Effect of upadacitinib on patient-reported outcomes in RA Strand, et al. presented two posters on patient-reported outcomes (PROs) with upadacitinib in the SELECT-NEXT and SELECT BEYOND studies. A total of 661 patients with active RA and an inadequate response to csDMARD were included in the analysis of PROs in SELECT-NEXT. Treatment with upadacitinib 15 mg or 30 mg daily for 12 weeks resulted in significant and clinically meaningful improvements in physical function, pain, fatigue, morning stiffness, QoL and work instability. Numbers Needed to Treat (NNT) with upadacitinib ranged from 4 to 8 patients [#0254]. A total of 498 patients with active RA and an inadequate response to bDMARDs were included in the analysis of SELECT-BEYOND. Compared with placebo at Week 12, upadacitinib-treated patients reported higher responses that were statistically significant and clinically meaningful for HAQ-DI, PtGA pain, pain, duration and severity of morning stiffness and SF-36 Physical Component Summary (PCS). NNT with upadacitinib ranged from four to eight patients in this difficultto-treat cohort [#0255]. Tofacitinib efficacy and safety in RA Fleischmann and colleagues presented a post hoc analysis of the ORAL Strategy study describing the impact of background glucocorticoids on the safety and efficacy of tofacitinib (with and without MTX) and adalimumab with MTX. Patients with RA were randomised 1:1:1 to receive tofacitinib 5 mg BID, tofacitinib 5 mg BID plus MTX, or SC adalimumab 40 mg (every other week) plus MTX. In the cohort of 1146 patients who were randomised and treated, efficacy endpoints (ACR50 response rate, LDA, remission rates, change in HAQ- DI score) were generally similar for each treatment group when stratified by glucocorticoid use. Unexpectedly, glucocorticoid use did not appear to be associated with higher rates of AEs, discontinuations due to AEs, serious infection events, and SAEs [#0247]. Cumulative probability plots showing clinical and functional efficacy across treatments for patients with RA in the ORAL Strategy study were presented by Takeuchi, et al. The proportion of patients who achieved responses of ACR20, ACR50 and ACR70 was similar for tofacitinib 5 mg BID plus MTX, and adalimumab SC 40 mg (every other week) plus MTX every other week but was numerically smaller for tofacitinib 5 mg BID monotherapy. Reductions from baseline in HAQ-DI were similar across treatment groups, although a slightly higher proportion of patients who received tofacitinib monotherapy reported an increase in HAQ-DI compared with other treatments. These data are consistent with the primary ORAL Strategy findings [#0252]. Wiesenhutter examined the utility of various disease activity measures (DAMs) for clinical decision making during implementation of a treat-to-target (T2T) strategy, following the initiation of tofacitinib (n=39) and TNFis (n=40). Patients at a rheumatology clinic underwent disease activity measure (DAM) assessments, which included conventional clinical assessments, DAS28CRP, and the CDAI, as well as the ultrasound power Doppler joint count (UPDJC) and multi-biomarker disease activity score (MBDA). Patients underwent regular assessments, and if found to have inadequate control, changes were made in their clinical regimen and reassessment was performed 3 to 6 months later. All of the DAMs resulted in significant clinical responses with the exception that following the initiation of tofacitinib, the MBDA did not result in clinically significant improvement. When individual biomarkers from the MBDA were analysed, TNFi therapy led to significant reduction in 6 of 12 biomarkers (IL-6, TNF-R1, TNF-R2, MMP-2, SSA and CRP), whereas
treatment with tofacitinib lead to significant reduction of 2 (VCAM and resisten) and borderline reduction in 2 (IL-6 and TNF-R1), and a significant increase in one (leptin). [#0089]. Effect of tofacitinib on patient-reported outcomes in RA Patient-reported outcomes (PROs) in the ORAL Strategy study were reported by Strand and colleagues. Patients with RA and an inadequate response to MTX were randomised 1:1:1 to receive tofacitinib 5 mg BID, tofacitinib 5 mg BID plus MTX, or adalimumab 40 mg (SC, Q2W) plus MTX; PROs were assessed at 6 and 12 months, and included HAQ-DI, patient global assessment (PtGA) visual analog scale) VAS, pain VAS, SF-36 Health Survey, EuroQol (EQ)-5D VAS, Work Productivity and Activity Impairment (WPAI) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Baseline and disease characteristics were similar among the 1146 treated patients. At 6 and 12 months, improvements in PROs were similar with tofacitinib plus MTX and adalimumab plus MTX, and were numerically greater than with tofacitinib monotherapy [#0256]. Tofacitinib efficacy and safety in PsA Helliwell, et al. showed that tofacitinib improved composite measures of disease in 2 Phase 3 studies of patients with PsA. Patients with active PsA and either an inadequate response to ≥1 csDMARD and who were TNFi-naïve (OPAL Broaden; N=422) or with an inadequate response to ≥1 TNFi (OPAL Beyond; N=394) were assessed for Psoriatic Arthritis Disease Activity Score (PASDAS), DAS28-3(CRP), disease activity score for reactive arthritis (DAREA)/ Disease Activity index for Psoriatic Arthritis (DAPSA) and CPDAI. In each study, both 5 mg BID and 10 mg BID doses of tofacitinib showed improvements in composite endpoints versus placebo at 3 months; the largest effect size and standardised response means were observed for PASDAS [#0323]. A post hoc analysis of the OPAL Broaden and OPAL Beyond studies was presented by Ritchlin and colleagues; this analysis examined tofacitinib efficacy and safety in patients with PsA and comorbid metabolic syndrome (MetS) and included 294 patients with active PsA plus MetS, and 416 patients with active PsA and without MetS. Tofacitinib efficacy was generally similar in patients with and without MetS, as determined by ACR20 response rate, change in HAQ-DI, Psoriasis Area and Severity Index (PASI)75 response rate, change in and PtGA VAS. In patients with MetS, AEs and SAEs occurred in 55.6% and 2.0% (respectively) of patients receiving tofacitinib 5 mg, and in 42.6% and 2.0% of those receiving tofacitinib 10 mg; corresponding rates in patients without MetS were 42.4% and 1.4% (5 mg) and 54.8% and 1.5% (10 mg). The authors concluded that tofacitinib showed a generally similar efficacy and safety profile in patients with PsA with or without MetS [#0317]. Burmester, et al. reported minimal changes in absolute lymphocyte counts and lymphocyte subset counts in tofacitinib-treated patients with PsA, up to 6 months. An analysis of pooled data the Phase 3 OPAL Broaden and OPAL Beyond studies of tofacitinib in 816 patients with PsA who had an inadequate response to ≥1 csDMARD or ≥1 TNFi found minimal decreases in total T cells (CD3+), cytotoxic T cells (CD8+) NK cells (CD16+56+) and a numerical increase in B cells (CD19+). Up to Month 12, serious infections were reported in seven tofacitinib-treated patients and one adalimumab-treated patient. There
Page 1 and 2: Enhancing knowledge of the clinical
Page 3 and 4: Highlights from EULAR 2018 During t
Page 5 and 6: Poster Sessions Poster Tour: Novel
Page 7: Poster sessions I, II and III Upada
Page 11 and 12: Baricitinib dose step-down followin
Page 13 and 14: Publication only Efficacy and safet
Page 15 and 16: A case study of vasculitis in a pat
Page 17 and 18: In a separate dedicated Phase 1 stu
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