EULAR 2018 Review

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monocytes to differentiate into dendritic cells translated into a functional impairment of phagocytic ability. NOX5 protein expression was significantly decreased in pre-treated Mo- DC from PsA patients, and to a lesser extent in cells from RA patients. The authors proposed that inhibition of Mo-DC development by tofacitinib may alter migration of DC to the joint and subsequent activation of the immune response [#0046]. Post hoc analyses of baricitinib Phase 3 studies Hepatic safety in patients with RA who received isoniazid (INH) for latent TB (LTBI) was reported by Hsieh et al. In this post hoc analysis of data from 3 Phase 3 baricitinib studies (n=2516 patients; RA-BEAM, RA BUILD, RA BEACON), 246 patients reported LTBI and 169 had confirmed laboratory data and received INH as LTBI treatment. The percentage of patients with greater than one times the ULN levels of ALT was numerically higher in patients in the INH group versus no INH, and was consistent across placebo, baricitinib and adalimumab treatment groups. No treatment interruptions or discontinuations were reported in INH users in the baricitinib or adalimumab groups. The authors concluded that the data do not suggest an increased hepatic safety risk in patients receiving baricitinib and INH concomitantly [#0098]. A post hoc analysis of the RA-BEAM and RA-BEGIN studies in patients with RA was reported by de Vlam, et al. The analysis showed that controlling disease activity by achieving LDA or remission increases the chance to regain normal physical function and relieve pain, independent of treatment (baricitinib monotherapy, baricitinib plus MTX or adalimumab). The data from RA-BEAM may indicate that achieving no/limited pain at Week 12 may be more likely with baricitinib compared with adalimumab, when achieving remission (83% versus 73%) [#0258]. Pope and colleagues reported a post hoc analysis of RA-BEAM. The authors showed that reductions in pain and fatigue were associated with improvements in regular daily activities, presenteeism and work productivity, with patients who reported lower levels of fatigue and pain tending to experience greater improvements compared with patients with higher levels of pain and fatigue. When patients achieved a minimal level of pain (pain VAS ≤10 mm), similar improvements in presenteeism and work productivity were observed regardless of fatigue level. Similar results were observed between treatment groups [#0240]. Phase 1 pharmacokinetic studies with upadacitinib in volunteers with renal impairment Mohamed, et al. reported results from a Phase 1 study that examined the pharmacokinetics of upadacitinib in 24 volunteers with either normal renal function or mild, moderate or severe renal impairment. In participants with mild, moderate and severe hepatic impairment, point estimates for plasma exposure ratios following a single 15 mg dose were 1.18, 1.33 and 1.44 for AUC and 1.06, 1.11 and 1.14 for maximum plasma concentration, relative to participants with normal renal function. The authors concluded that renal impairment has only limited effect upon upadacitinib pharmacokinetics, with mean plasma exposure in participants with severe renal impairment within 44% of that observed in patients with normal renal impairment [#0479].
In a separate dedicated Phase 1 study, Mohamed and colleagues examined the pharmacokinetics of upadacitinib in 18 volunteers with either normal renal function, or mild or moderate renal impairment. In participants with mild and moderate hepatic impairment, upadacitinib exposure ratio central values following a single 15 mg dose were 1.28, 1.24 for AUC and 1.04, and 1.43 for maximum plasma concentration, relative to participants with normal renal function. The authors concluded that renal impairment has very limited effect upon upadacitinib pharmacokinetics (
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 and 8: Poster sessions I, II and III Upada
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Page 15: A case study of vasculitis in a pat
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EULAR 2018 Review

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