Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial

Abstract

Eli Lilly and Company.

New therapies for systemic lupus erythematosus — past imperfect, future tense

“…In a pre-clinical study, tofacitinib (a JAK1and JAK3 inhibitor) reduced both kidney disease and the concentration of pathogenic autoantibodies in lupus-prone mice 87 . The results of a phase II trial of baricitinib 88 (an oral JAK1 and JAK2 inhibitor) in 314 patients with SLE who have active cutaneous disease or musculoskeletal activity were reported in 2018. 67% of patients receiving 4mg/day baricitinib achieved a SLEDAI-2K response at 24 weeks, which was significantly more than those receiving placebo (53%; P=0.04) 88 .…”

“…The results of a phase II trial of baricitinib 88 (an oral JAK1 and JAK2 inhibitor) in 314 patients with SLE who have active cutaneous disease or musculoskeletal activity were reported in 2018. 67% of patients receiving 4mg/day baricitinib achieved a SLEDAI-2K response at 24 weeks, which was significantly more than those receiving placebo (53%; P=0.04) 88 . Treatment with 4mg/day baricitinib also reduced the proportion of patients with 'worst joint pain' compared with placebo and improved PGA and low disease activity scores; however, the 2mg/day dose of baricitinib did not show any benefit compared with placebo 64 .…”

A promising approach to targeting type 1 IFN in systemic lupus erythematosus

“…Amidst this backdrop exist signs of hope. Phase II study results of baricitinib, an oral selective and reversible JAK1 and JAK2 inhibitor (4), and ustekinumab, an anti-IL-12/23 mAb (5), have been promising. Post hoc analysis from a phase II study (6) of the anti-IL-6 mAB PF-04236921 revealed efficacy and safety, and trends toward treatment response were observed in a recent phase IIb trial (7) and long-term extension study (8) of atacicept, a dual inhibitor of a proliferation-inducing ligand (APRIL), and B cell activating factor of the TNF family (BAFF).…”

Immunoinflammatory Rheumatic Diseases Associated With Type I Interferon: New Evidence

“…Установлена быстрая положительная динамика артрита (n=4) и кожной сыпи (n=6), в отсутствие нормализации титров анти-ДНК и С3-компонента комплемента. Совсем недавно были получены данные РПКИ (фаза II; n=314; 24 нед) о применении барицитиниба при СКВ с преимущественным поражением суставов и кожи [118]. Пациенты были рандомизированы на три группы: барицитиниб 4 и 2 мг/сут и ПЛ -и получали стандартную базовую терапию, включающую нестероидные противовоспалительные препараты, ГК в дозе ≤20 мг/сут, ГХ или один иммуносупрессивный препарат (МТ, азатиоприн или микофенолата мофетил).…”