interleukin-2 on active dermatomyositis

Conditions: Dermatomyositis

Summary: the purpose of this paper is to explore the effect of low-dose il-2 on refractory dermatomyositis and immunological indexes.

a randomized, double-blind, placebo-controlled, multicenter clinical trial was designed. patients were treated with low-dose il-2 regularly to explore its efficacy and safety. the improvement of clinical and laboratory indexes was evaluated. changes of immune cell subsets and cytokines were monitored.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years old (including 18 and 75 years old); 2. the diagnosis of dermatomyositis conforms to bohan/peter recommendation in 1975 or eular/acr classification standard in 2017. active myositis was defined by baseline manual muscle testing (mmt-8) no greater than 125/150 and at least two additional abnormal csms. to allow the enrolment of patients with active dm with a moderate to severe rash who may not meet the mmt-8 criterion noted above, patients with dm could be enrolled if their cutaneous vas score on the myositis disease activity assessment tool (mdaat) was ≥3cm on the 10cm vas scale and at least three of the five csms were abnormal (excluding the mmt-8). abnormal csms include: * 1. patients global assessment (pga), the minimum value of 10 cm visual analog scale (vas) is 2.0 cm * 2. physicians global assessment (phga), the minimum value on the 10 cm vas scale is 2.0 cm * 3. health assessment questionnaire (haq), with a minimum value of 0.25 * 4. at least one muscle enzyme \[including creatine kinase (ck), aldolase, lactate dehydrogenase (ldh), alanine aminotransferase (alt) and aspartate aminotransferase (ast)\] high, the lowest level is 1.3 x upper limit normal * 5. global extra-muscle disease activity score, with a minimum of 1.0 cm on the 10 cm vas scale \[this measure is a comprehensive assessment by the physician based on an assessment of the physique, skin, bone, gastrointestinal, lung and heart scale activity scores,named myositis disease activity assessment tool (mdaat)\]. * 6. manual muscle testing (mmt-8) no greater than 125/150. 3. the dose of glucocorticoid (equivalent to prednisone) was less than 0.5mg/kg/d within 4 weeks before joining the group, and/or there were no new immunosuppressants (cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, methotrexate, etc.) within 12 weeks, and the dose was stable for 4 weeks. 4. voluntary signing of informed consent: when participating in the trial, the patient must be given a written notice of consent, and hope that the patient can comply with the requirements of the study follow-up plan and other protocols. 5. agree to adopt effective contraceptive measures during the study period (women of childbearing age). exclusion criteria: any subject meeting any of the following criteria should be excluded: 1. received intravenous glucocorticoid (\> 1 mg/kg/d) within 4 weeks; 2. serious complications: including (1). heart failure (≥ nyha iii); (2). renal insufficiency (creatinine clearance rate ≤30 ml/min); (3). liver insufficiency (excluding serum alt or ast caused by dermatomyositis, or total bilirubin greater than normal upper limit), (4). hemoglobin \< 80g/l, e. platelet count \< 60. 3. dermatomyositis patients with other connective tissue diseases or tumors; 4. allergic constitution or allergic to multiple drugs; 5. those who are in the period of acute and chronic infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, epstein-barr virus, tuberculosis infection), or are hospitalized for infection, or use intravenous antibiotics to treat infection 2 months before the first treatment, or have a history of active tuberculosis in the past; 6. those who are positive for hepatitis b surface antigen or hepatitis c antibody; 7. persons with mental illness or other reasons who cannot cooperate with treatment.