ACR Congress Review 2019

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Baricitinib Pain relief with baricitinib in RA A post-hoc analysis of pain improvement in the RA-BEAM study was presented by Taylor and colleagues. A total of 1,305 patients on a stable background of MTX were randomised and received oral baricitinib 4 mg QD, SC adalimumab 40 mg EOW, or placebo. At Week 12, the percentages of patients who achieved remission with placebo, adalimumab, and baricitinib, respectively, were 2%, 7%, 8%; for low disease activity: 15%, 27%, 33%; for moderate disease activity: 33%, 40%, 38%. At all CDAI values, the estimated change in pain VAS for baricitinib was greater versus placebo and adalimumab. Similar trends were observed with other disease activity measures. Baricitinib demonstrated greater pain improvement versus adalimumab and placebo in all disease activity categories. With CDAI/SDAI, greater differentiation between baricitinib and adalimumab was observed as CDAI/SDAI values increased. In summary, baricitinib provided additional pain improvement versus placebo and adalimumab when disease activity was controlled and across all levels of disease activity, as measured by CDAI, SDAI, DAS28-CRP, or DAS28-ESR at Week 12 [1407*]. Pope and colleagues presented an analysis of data from the RA-BEAM, RA-BUILD, and RA-BEACON trials to examine pain relief with baricitinib in opioid users and non-opioid users. A pooled analysis of RA patients from the RA-BEAM (MTX-IR), RA-BUILD (cDMARD-IR) and RA-BEACON (TNF-IR) trials showed that pain reduction with baricitinib 4 mg was similar between opioid users and non-users and was observed at all time points. In RA-BEAM, pain reduction with baricitinib 2 mg versus placebo was similar between opioid users and non-users from Week 12. A significant difference in pain reduction was not observed for adalimumab versus placebo in the opioid users; whereas, for non-users, a difference in pain reduction was observed for adalimumab versus placebo at all time points (P
Update on JAK inhibitor safety data Upadacitinib Upadacitinib safety in the SELECT clinical program Findings from an integrated analysis of the upadacitinib safety profile from the SELECT Phase 3 clinical program were presented in three posters. Cohen and colleagues presented exposure-adjusted event rates (EAERs) and key safety data. Across the five Phase 3 trials, 3834 patients received one or more dose of upadacitinib 15 (n=2630) or 30 mg QD (n=1204). The EAERs of overall SAEs and AEs leading to discontinuation on upadacitinib 15 mg were comparable to adalimumab; while the rates of both were higher on upadacitinib 30 versus upadacitinib 15 mg and MTX. Rates of deaths were comparable across the treatment groups. Serious infection rates were comparable between upadacitinib 15 mg and adalimumab, while higher on upadacitinib compared with MTX. Rates of herpes zoster were higher in both upadacitinib groups versus MTX and adalimumab. The rates of serious infections and herpes zoster were higher on upadacitinib 30 versus 15 mg. Rates of VTE, MACE, and malignancy were comparable with that observed in the MTX and adalimumab groups while also being consistent with reported rates in the RA population [509*]. Choy and colleagues presented an analysis focusing on MACE and VTE. The EAERs of MACE and VTE in the upadacitinib groups were comparable to placebo, MTX and adalimumab. Approximately 40% of MACEs and 1 PE event (upadacitinib 15 mg) were fatal. All patients with a MACE or VTE event had one or more CV risk factors (hypertension, diabetes, dyslipidaemia) or one or more VTE risk factor (prior history of thrombotic event, obesity, or hypertension) at baseline, respectively. Treatment with upadacitinib increased the levels of LDL-C and HDL-C, however, their ratio remained constant over time and there was no association of LDL‐C increases and MACE occurrences. No dose‐response or pattern of time-to-VTE-onset was observed with either upadacitinib dose [846*]. An integrated, long-term safety analysis of upadacitinib in Japanese patients was presented by Yamaoka and colleagues. The analysis included a total of 371 Japanese patients who received upadacitinib 7.5 (n=121), 15 (n=126), or 30 mg QD (n=124) in one of three clinical studies (SELECT- SUNRISE, SELECT-EARLY or SELECT-MONOTHERAPY). Among the Japanese population, EAERs were consistently higher in the 30 mg group compared with the 15 mg and 7.5 mg groups. EAERs in the 15 mg and 7.5 mg groups were comparable. In comparison with the global population, EAERs in the 15 mg and 30 mg groups was higher in the Japanese population. The EAER of infections (including herpes zoster) was also higher in the Japanese population compared with the global population. In contrast, EAERs of AESI (including malignancies, cardiovascular disorders, hepatic disorders, and laboratory abnormalities) were comparable between the Japanese and global populations [2407]. Baricitinib Long-term baricitinib safety in RA The long-term safety and efficacy profile for baricitinib up to 7 years was presented by Genovese et al. The analysis included 3770 patients with RA (10,127 patient-years of exposure) from 9 randomised trials and an ongoing open-label, long-term extension study. No significant differences were seen for baricitinib 4 mg versus placebo in AEs leading to permanent drug discontinuation, death, malignancy, serious infection, or MACE. The incidence rate of herpes zoster was significantly higher for baricitinib 4 mg versus placebo (3.8 versus 0.9) and numerically higher for baricitinib 2 mg (3.1). Incidence rates for DVT/PE were numerically higher in baricitinib 4 mg versus placebo. Malignancy (excluding *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 and 8: treatment with MTX. A total of 1629
Page 9 and 10: Individual and composite measures o
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: Patient-reported outcomes with JAK
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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