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The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with rheumatic diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis).
The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.
Methods: Patients were divided into two groups. One received standard therapy, while another one administrate with low-does IL-2 plus standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Human Interleukin-2 | Experimental | Induced remission period,recombinant human IL-2(500,000 unit per square meter) infusions five days;Maintenance treatment period,recombinant human IL-2 infusions five days then once every two weeks for 6 months. |
|
| Traditional therapy | No Intervention | Patients were treated with glucocorticoid and/or immunosuppressor. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-2 | Drug | Patients were received low dose recombinant human Interleukin-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in steroid dose and immunosuppressor dose at 1 year compared to control group | The average daily doses of steroid and immunosuppressor per square meter was recorded | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The Immunologic Impact of IL-2 Treatment | Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres. | 1 month,3 month,6 month,1 year |
| Immunological Responses | Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sirui Yang, MD and PhD | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sirui Yang | Changchun | Changchun/Jilin | 130000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30472651 | Background | Rosenzwajg M, Lorenzon R, Cacoub P, Pham HP, Pitoiset F, El Soufi K, RIbet C, Bernard C, Aractingi S, Banneville B, Beaugerie L, Berenbaum F, Champey J, Chazouilleres O, Corpechot C, Fautrel B, Mekinian A, Regnier E, Saadoun D, Salem JE, Sellam J, Seksik P, Daguenel-Nguyen A, Doppler V, Mariau J, Vicaut E, Klatzmann D. Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial. Ann Rheum Dis. 2019 Feb;78(2):209-217. doi: 10.1136/annrheumdis-2018-214229. Epub 2018 Nov 24. | |
| 16227984 |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| C082598 | aldesleukin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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One group patients were treated with IL-2 and another group patients were treated with routine therapy.
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| 1 month,3 month,6 month,1 year |
| Change from baseline in SELENA SLEDAI Score | Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. The higher the score represent the worse of the disease. The total score ranges from 0 to 105 points. | 1 month,3 month,6 month,1 year |
| Change from baseline in EULAR SS disease activity index | Low-activity (ESSDAI<5),moderate-activity (5≤ESSDAI≤13) ,high-activity (ESSDAI≥14) levels. | 1 month,3 month,6 month,1 year |
| Incidence of adverse drug reactions | Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage. | up to 1 year |
| Background |
| Fontenot JD, Rasmussen JP, Gavin MA, Rudensky AY. A function for interleukin 2 in Foxp3-expressing regulatory T cells. Nat Immunol. 2005 Nov;6(11):1142-51. doi: 10.1038/ni1263. Epub 2005 Oct 16. |
| 18062768 | Background | Malek TR. The biology of interleukin-2. Annu Rev Immunol. 2008;26:453-79. doi: 10.1146/annurev.immunol.26.021607.090357. |
| 21488890 | Background | Cheng G, Yu A, Malek TR. T-cell tolerance and the multi-functional role of IL-2R signaling in T-regulatory cells. Immunol Rev. 2011 May;241(1):63-76. doi: 10.1111/j.1600-065X.2011.01004.x. |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |