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Exploratory Study to Evaluate the Efficacy and Safety of Baricitinib in Interstitial Pneumonia Associated with Anti-MDA5 Antibody-Positive Dermatomyositis

Exploratory Study to Evaluate the Efficacy and Safety of Baricitinib in Interstitial Pneumonia Associated with Anti-MDA5 Antibody-Positive Dermatomyositis

Fujio Keishi

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

FUJIOK-INT@h.u-tokyo.ac.jp

Kono Masanori

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

+81-3-3815-5411

mkouno-tky@g.ecc.u-tokyo.ac.jp

Recruiting

Feb. 16, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Those who are positive for anti-MDA5 antibody.
2. Those who meet the definition of clinically amyopathic dermatomyositis (CADM) or classical DM proposed by Sontheimer.
3. Those who have interstitial pneumonia on chest CT.
4. Those who are between 18 and 75 years of age at the time consent is obtained.
5. Gender is not required.
6. Any immunosuppressive therapy prior to participation in this study is acceptable.
7. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study.
8. Those who can conduct inspections in accordance with the research implementation schedule.

1. Those who have serious infection.
2. Those who have active tuberculosis.
3. Those who have a neutrophil count of less than 500 /mm3.
4. Pregnant women or those who may be pregnant.
5. Those who are on dialysis or with severe renal insufficiency (eGFR<30 mL/min/1.73m2).
6. Those who have a lymphocyte count less than 200 /mm3.
7. Those who are positive for HBs antigen or HBV-DNA
8. Those who are undergoing treatment for malignancy or have a history of malignancy within 5 years.
9. Those who are using a JAK inhibitor other than baricitinib.
10. Those who have active thrombosis (within 30 days of onset).
11. Those who are judged by clinical research physicians to be inappropriate to participate in this trial by other reasons.

Both

Interstitial pneumonia associated with anti-MDA5 antibody-positive dermatomyositis

Subjects will take baricitinib 4 mg once daily for 6 months from the start of treatment until the end of treatment.
For patients with 30<=eGFR<60, the dose of baricitinib should be reduced to 2 mg once daily. A reduced dose of baricitinib 2 mg once daily is acceptable depending on the patient's condition. In addition, drug withdrawal at the onset of adverse events is acceptable.

Incidence and rate of Grade 3 (CTCAE v5.0) or higher adverse events

1. Survival rate after 6 months of treatment
2. Presence of exacerbation of interstitial pneumonia on Chest CT
3. Percent change in ferritin, KL-6, and anti-MDA5 antibody titers

+81-3-5841-0818

Feb. 01, 2023

No

none