EULAR 2018 Review

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interruption visit, AEs, SAEs and discontinuations due to AEs occurred in 54.4%, 11.1% and 1.5% of patients, respectively. The authors concluded that there was no loss of efficacy after temporary withdrawal of tofacitinib, and that the safety profile was consistent with that observed in previous LTE studies over 9 years [#0037]. Malignancy and serious infection rates in clinical trials of JAK inhibitors for RA Lopez-Olivio, et al. presented a systematic review and meta-analysis of malignancies and serious infections during randomised controlled trials of JAK inhibitors in patients with RA. Thirty-one trials including 13 945 patients were included. Reported rates of malignancies across studies ranged from 0% to 2.0%, and rates of serious infections ranged from 0.7% to 5.4%. The most commonly reported malignancies were lung cancer, melanoma, nonmelanoma skin cancer (NMSC), basal cell and squamous cell carcinoma. Patients receiving the combination of JAK inhibitor plus MTX or JAK inhibitor monotherapy had numerically higher rates of malignancies, compared with MTX between 12 and 24 weeks before the rescue treatment was implemented (odds ratio [OR] 2.48, 95% confidence intervals [CI] 0.76–8.11 and OR 1.39, 95% CI 0.21–9.11, respectively). JAK inhibitor groups had similar rates of serious infections to those observed in the control groups. However, higher rates of serious infections were observed in patients receiving higher doses of JAK inhibitors [#0032]. Abstract Session: Fires and firefighters: switching the immune system on and off Joint-specific differences in activation of the JAK-STAT pathway in RA Masterson and colleagues presented findings on substantial quantitative and qualitative differences in the JAK-STAT signalling pathway in synovial fluid (SF) from different joints. Using synovial fluid isolated from knee, shoulder and hand joints from patients with RA and osteoarthritis who were undergoing joint replacement surgery, the authors showed that the JAK-STAT pathway was enriched in knee SF versus hand and shoulder SF. Knee SF exhibited increased expression of JAK and STAT genes and enhanced signalling upon stimulation with IL-6/sIL-6R. The authors suggest that RA in different joints might not be equally sensitive to JAK-kinase inhibitors or blockade of IL-6, which has important implications for clinical practice and drug discovery in this therapy area [#0165].
Poster Sessions Poster Tour: Novel insights on non-biologics in RA Efficacy and safety of baricitinib at 52 weeks in the Phase 3 RA-BALANCE trial Li and colleagues presented 52-week efficacy and safety results from the Phase 3 RA- BALANCE trial. The study enrolled patients from China, Argentina and Brazil with moderately to severely active RA despite a stable background of MTX; patients received baricitinib 4 mg QD or PBO for 24 weeks, when patients receiving placebo were switched to receive baricitinib 4 mg QD until end of study. The primary endpoint, ACR20 at Week 12, was significantly greater with baricitinib compared with placebo (58.6% versus 28.3%, P≤0.001). The ACR20 response observed at 12 weeks was maintained through 52 weeks in patients receiving baricitinib (Week 24: 64.1%; Week 52, 62.8%). Significant improvements in HAQ-DI physical function (PF), duration and severity of morning joint stiffness, and worst tiredness were observed at Week 12 with baricitinib versus placebo. Treatment-emergent adverse events (TEAEs) and serious infections during Weeks 0–24 were reported in 74.5% and 42.1% of baricitinib patients (respectively) compared with 62.1% and 28.3% of patients receiving placebo. No major adverse cardiovascular events (MACE), deaths, TB, venous thromboembolisms or malignancies were reported through Week 52 with baricitinib, and no unexpected safety signals were observed [#0218]. Upadacitinib Phase 3 study results A poster by Genovese, et al. presented the results of a Phase 3, randomised, placebocontrolled trial of upadacitinib in patients with active RA and an inadequate response or intolerance to bDMARDs. In this study, patients received upadacitinib 15 mg or 30 mg QD, or placebo, followed by upadacitinib 15 mg or 30 mg QD starting at Week 12. Compared with placebo, more patients receiving upadacitinib achieved the primary endpoints of ACR20 and proportion achieving DAS28CRP≤3.2 (both at Week 12). Among patients with an inadequate response to multiple bDMARDs/MOAs, and those with lack of efficacy for alpha-IL-6, the proportions achieving ACR20 on upadacitinib versus placebo were comparable to the overall treated population. Overall rates of AEs were slightly higher for upadacitinib 30 mg QD versus upadacitinib 15 mg QD, and there were more serious infections and HZ cases in patients receiving upadacitinib 30 mg. PE was reported in two patients through Week 12, and four more patients through Week 24; all had risk factors for DVT/PE. One death in each upadacitinib dose group was reported. The overall safety profile was considered consistent with Phase 2 and other Phase 3 studies of upadacitinib [#0219]. Tofacitinib and the effect of live zoster vaccine on herpes zoster events in RA Calabrese, et al. presented an evaluation of LZV in a subset of 1146 patients with RA treated with tofacitinib with or without MTX, and adalimumab plus MTX in ORAL Strategy. A total of 216 patients received vaccination with LZV. No patients had zoster-like lesions within 42 days of vaccination; one had vaccination-site erythema. In the overall study population, the incidence rate of HZ was similar between tofacitinib monotherapy and adalimumab plus MTX, and numerically higher with tofacitinib plus MTX. Overall, 18 patients had HZ; only three vaccinated patients had HZ. No events were serious, and only
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