EULAR 2018 Review

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1 case was multidermatomal. Among the patients who were not vaccinated, 15 had HZ, there were 2 serious HZ events, 2 multidermatomal events and 1 disseminated event [#0220]. Identification of heterogeneous phenotypic subgroups of patients with RA Bykerk and colleagues reported that it is possible to identify heterogeneous phenotypic subgroups with distinct disease activity in patients with RA who are csDMARD-IR and treated with tofacitinib. Models were based on pooled data from Phase 3 studies of tofacitinib 5 mg BID. The groups were characterised by differences in disease activity and patient-relevant outcomes, including baseline pain and physical function. The authors proposed that the identification of distinct disease trajectories could be used to develop personalised treatment algorithms incorporating clinical and molecular phenotypes [#0217]. Poster Tour: Breakout news on non-TNF biologics in RA Real world evidence: bDMARD treatment persistence and reasons for discontinuation A poster on reasons for bDMARD cessation and subsequent persistence of second-line treatment in a large real world rheumatoid arthritis registry was presented by Youssef, et al. The analysis included patients aged ≥18 years with confirmed RA who were treated with first line b/tsDMARDs (1 st August 2010 to 30 th June 2017) by physicians participating in the OPAL-QUMI database. A total of 6914 patients received first line b/tsDMARDs. Treatment was stopped in 38% of patients; 34% stopped within 6 months of initiation, with the highest and lowest percentage observed in patients receiving tofacitinib (54%) and tocilizumab (17%), respectively. The most common reasons for stopping therapy within 6 months were lack of efficacy (45%>abatacept, 44%>TNFis, 33%>tofacitinib and 27%>tocilizumab) and adverse reactions (21%> tofacitinib, 20%> tocilizumab, 15%>TNFis, 13%>abatacept). The percentage of patients remaining on 2nd line b/tsDMARD treatment after stopping first line TNFis due to lack of efficacy was the highest at 6 months with tocilizumab (78%) and at 12 months with rituximab (75%) [#0165]. Poster Tour: The hydra beast in RA: a multifaceted disease Tofacitinib development programme: liver enzyme abnormalities Soriano, et al. reported a prevalence of hepatic steatosis of 1.6% in 10,212 patients across the tofacitinib RA, PsA and PsO programmes (1.3% in RA, 3.8% in PsA and 1.6% in PsO). In both tofacitinib- and placebo-treated patients, the incidence of elevated total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >1x ULN up to Month 3 was higher in patients with hepatic steatosis than in those without, across indications. The incidence of elevated total bilirubin, AST and ALT >3x ULN up to Month 3 was low across indications, irrespective of hepatic steatosis [#0099].
Poster sessions I, II and III Upadacitinib efficacy and safety in RA FitzGerald, et al presented findings from the Phase 3 SELECT-NEXT (n=661) and SELECT-BEYOND (n=498) trials on the speed of response to upadacitinib across disease measures. In these cohorts of patients with RA and an inadequate response to csDMARDs or bDMARDs, those receiving upadacitinib at either 15 mg or 30 mg QD were more likely to achieve clinical responses at significantly earlier timepoints compared with patients receiving placebo. The median times to achieve ACR20 were 4 weeks with upadacitinib 15 mg QD, 2–3 weeks with upadacitinib 30 mg QD, and 12 weeks with placebo. The median time to low disease activity (LDA) by CDAI and SDAI was approximately 12 weeks across upadacitinib doses and populations; patients receiving placebo did not achieve this measure within that time. The time taken to achieve various clinical responses was consistent irrespective of having an inadequate response to csDMARD or bDMARD [#0239]. Vollenhoven, et al. examined upadacitinib efficacy at 12 weeks of treatment (as per T2T recommendations) in the SELECT-NEXT and SELECT-BEYOND trials. In both populations of patients with RA, significantly more patients on upadacitinib versus placebo achieved an ACR50 response. Among ACR50 responders at 12 weeks, approximately one-half of csDMARD-IR patients and one-third of the bDMARD-IR patients achieved an improvement in all 7 ACR components [#0244]. Genovese, et al. presented the long-term safety and efficacy profile for upadacitinib from an ongoing open-label, long-term extension (OLE) of two Phase 2 studies (BALANCE- EXTEND). This included 493 patients with RA, with a total of 725 patient-years of cumulative exposure. The event rate per 100 patient years (E/100PY) was 170.5 for any AE in the OLE, 9.4 for SAEs, 2.3 for serious infection, 3.7 for HZ, 0.8 for malignancies excluding NMSC, and 0.7 for adjudicated cardiovascular events. There were 2 deaths (1 sudden death adjudicated as unknown cause, and 1 due to Hodgkin’s lymphoma). Efficacy was maintained in patients receiving 6 mg upadacitinib BID from Day 1 of the OLE who completed Week 72 (55% of patients met ACR70, and 80% were in LDA by DAS28-CRP and CDAI) [#0236]. The results of a Phase 3/4, randomised, placebo-controlled, double-blind study of upadacitinib in Japanese patients with active RA and an inadequate response to csDMARDs were presented in a poster by Tanaka, et al. A total of 197 patients received treatment and 187 completed the double-blind period. ACR20 rates at 12 weeks in patients receiving upadacitinib 7.5, 15, and 30 mg or placebo were 75.5%, 83.7%, 80% and 42.9%, respectively. ACR50 and ACR70 responses were achieved by significantly higher proportions of patients receiving upadacitinib versus placebo; more patients receiving upadacitinib 15 mg and 30 mg achieved these responses compared with those receiving upadacitinib 7.5 mg. The overall safety and tolerability profile was consistent with that observed in Phase 2 and 3 studies to date. Rates of any AEs, SAEs and infections were numerically higher in patients receiving upadacitinib 30 mg compared with the lower upadacitinib doses and placebo groups; CPK elevations and lymphopenia occurred more frequently with upadacitinib 30 mg [#0257].
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