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This study is a prospective investigation comparing the efficacy and safety of Janus kinase inhibitors versus calcineurin inhibitors as initial therapy for interstitial lung disease associated with antisynthetase syndrome. The goal is to determine which treatment is more effective at improving lung function and preventing disease progression, while comparing their safety profiles. The findings will help provide clearer treatment guidance for doctors and patients.
This is a single-center, randomized, open-label, prospective study. Eligible adults with interstitial lung disease associated with antisynthetase syndrome (ASS-ILD) who are treatment-naïve will be randomly assigned to receive either a JAK inhibitor (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) or a calcineurin inhibitor (tacrolimus 0.075 mg/kg/day in two divided doses, or cyclosporine 2-5 mg/kg/day in two divided doses), both in combination with a standard glucocorticoid regimen. The primary endpoint is the 12-month survival rate. Secondary endpoints include changes in lung function, high-resolution CT (HRCT) scores, glucocorticoid dosage reduction, and the proportion of patients achieving low disease activity. Safety and laboratory parameters will be closely monitored throughout the 12-month treatment and follow-up period. Statistical analyses will compare the efficacy and safety profiles between the two treatment arms, and subgroup analyses will be performed to explore potential predictors of treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAK inhibitor group | Experimental | Participants in this arm will receive one of the JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) in combination with a standard glucocorticoid regimen (methylprednisolone 0.5g IV for 3 days, followed by oral prednisone 0.8-1.0 mg/kg/day tapered to 7.5 mg/day over 12 months). Treatment duration is 12 months. |
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| Calcineurin inhibitor group | Experimental | Participants in this arm will receive either tacrolimus (0.075 mg/kg/day in two divided doses) or cyclosporine (2-5 mg/kg/day in two divided doses) in combination with the same standard glucocorticoid regimen as the experimental group. Treatment duration is 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAK Inhibitor | Drug | Oral JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) administered in combination with standard glucocorticoid therapy for 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month survival rate | Proportion of participants surviving at 12 months after randomization, with survival defined as the time from randomization to death from any cause. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Annual decline rate of lung function (FVC% and DLCO%) | The annual rate of decline in forced vital capacity (FVC% predicted) and diffusing capacity for carbon monoxide (DLCO% predicted), calculated as the change from baseline to 12 months. | Change from baseline to 12 months |
| Change in HRCT score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinghong Liu, MD | Contact | +86 15774917676 | 166618530@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| Calcineurin Inhibitors (CNI) | Drug | Oral calcineurin inhibitors (tacrolimus 0.075 mg/kg/day in two divided doses, or cyclosporine 2-5 mg/kg/day in two divided doses) administered in combination with standard glucocorticoid therapy for 12 months. |
|
Change in high-resolution computed tomography (HRCT) score from baseline to 12 months, assessed using a standardized scoring system. |
| Change from baseline to 12 months |
| Rate of glucocorticoid tapering | The rate of glucocorticoid dose reduction over 12 months, calculated as the time to achieve prednisone ≤7.5 mg/day or the cumulative glucocorticoid dose. | Over 12 months |
| Proportion of patients achieving low disease activity (LDA) | Proportion of participants achieving low disease activity (LDA) at 6 and 12 months, defined as meeting all of the following criteria: no active arthritis without regular NSAID use; no active myositis with serum creatine kinase ≤ upper limit of normal; stable ILD with no decline in pulmonary function (FVC decline <5% and DLCO decline <10% in the past 6 months); no fever or other systemic manifestations with ESR <20 mm/h; stable glucocorticoid dose ≤7.5 mg/day (prednisone equivalent) for at least 3 months. | At 6 months and 12 months |
| ID | Term |
|---|---|
| C537778 | Antisynthetase syndrome |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000075242 | Janus Kinase Inhibitors |
| D065095 | Calcineurin Inhibitors |
| ID | Term |
|---|---|
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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