Baricitinib for Cutaneous Dermatomyositis

Exclusion Criteria

• •1. Previous treatment with baricitinib.
• •2. Previous treatment with tofacitinib or updacitinib.
• •3. Current use of strong Organic Anion Transporters 3 (OAT3) inhibitors including probenecid.
• •4. Uncontrolled or rapidly progressive myositis or interstitial lung disease at the discretion of the investigator which is likely to warrant escalation in therapy beyond permitted background medications.
• •5. Cancer-associated myositis (myositis diagnosed within 2 years of a diagnosis of cancer).
• •6. Patients who are known to be positive for the anti-TIF1-γ (p155/140) or anti-NXP2 autoantibody unless they are determined not to be associated with malignancy at the discretion of the investigator.
• •7. Other inflammatory diseases that might confound the evaluations of efficacy including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), psoriatic arthritis, inflammatory bowel disease.
• •8. Recurrent or chronic bacterial, viral, fungal, mycobacterial, or other infections including HIV, Hepatitis B or C, latent TB (TB not adequately treated according to guidelines)
• •9. History of recurrent herpes zoster, disseminated (multi-dermatomal) herpes zoster, disseminated herpes simplex or ophthalmic zoster. Herpes zoster lesions within 90 days prior to screening.
• •10. Primary or secondary immunodeficiency.
• •11. Current uncontrolled renal, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease, which, in the opinion of the investigator, might place the patient at unacceptable risk for participation in this study.
• •12. History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix and non-melanoma skin carcinoma.
• •13. History of lymphoproliferative disease, including lymphoma, and monoclonal gammopathy of undetermined significance.
• •14. History of venous thromboembolism, including deep vein thrombosis and pulmonary embolism.
• •15. History of alcohol, drug, or chemical abuse within one year prior to signing the informed consent form.
• •* Hemoglobin (Hgb) \< 8g/dL
• •* White Blood Count (WBC) \< 3,000/μL fidential Page 13 of 40
• •* Absolute Neutrophil Count (ANC) \< 1,500/μL
• •* Absolute Lymphocyte Count (ALC) \< 800/μL
• •* Platelets \< 100,000/μL
• •* eGFR \< 60 ml/min
• •* ALT or AST \>1.5 times ULN not due to DM.
• •17. Major surgery within 8 weeks prior to Screening or planned major surgery at any time during participation in the study.
• •18. Immunization with a live/attenuated vaccine within 4 weeks prior to Screening.
• •19. Pregnant or nursing women, or women of child-bearing potential who plan to become pregnant prior to 14 weeks after the last dose of baricitinib treatment.
• •20. Patients of reproductive potential not willing to use a highly effective method of contraception as defined in Section 5.3.1.10.
• •21. Prisoners, or subjects who are compulsory detained, or cannot provide informed consent without the use of a legally authorized representative (LAR).