Baricitinib in Patients With Relapsing or naïve Dermatomyositis
Status:
Not yet recruiting
Trial end date:
2025-04-01
Target enrollment:
Participant gender:
Summary
Dermatomyositis (DM) is a rare and disabling condition with an important impairment of
quality of life and possible life-threatening complications.
Treatment is based on high doses of corticosteroids but this exposes patients to adverse
events (cardiovascular mortality, glucocorticoids-induced muscle and skin damages).
Corticosteroids taper is associated with disease relapses. Although there is no evidence from
the literature, clinical practice guidelines recommends the use of DMARDs such as
methotrexate. However, response is not complete and these DMARDS take time to act.
The interferon type I (IFN-I) pathway is involved in the pathophysiology of DM. Janus kinase
1 and 2 transduces IFN-I signals. In addition, JAK2 inhibition enhances muscle repair and
force generation.
JAK 1/2 inhibitors permitted to dramatically and rapidly improve relapsing DM patients (n=4,
case series).
Our hypothesis is that Janus kinase 1 and 2 (JAK1/2) inhibitors (baricitinib) will permit to
obtain dermatomyositis (DM) improvement with a steroid sparing effect as compared to usual
care.
Our primary objective is to evaluate the efficacy of baricitinib (JAK1/2 inhibitor) to obtain
prednisone-free moderate improvement (ACR/EULAR ≥ 40) of DM as compared to placebo in
addition to usual care.
BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two
parallel arms (1:1). This is an add-on trial to usual care with rapid corticoid taper.
This is a multicenter trial in different medical departments in hospitals across France in
different regions.
Out- and in patients will be recruited in hospital departments involved in management and
diagnosis of DM: departments of dermatology, rheumatology and internal medicine.