The Incidence of Infection in Treatment of Low-dose IL-2 of SLE Patients

The Incidence of Infection in Treatment of Low-dose IL-2 Combined With Corticosteroid and Immunosuppressor in SLE Patients- a Multi-center Prospective Study

IL-2 is a pleiotropic cytokine which can regulate or stimulate the differentiation and function of CD4+, CD8+ and NK cells. An opened-labelled trial and a retrospective study have indicated the incidence of infection is lower in the treatment of low-dose IL-2 combined with corticosteroid and immunosuppressor. We are going to conduct a multi-center prospective observational study to verify the above results.

Study Overview

• Status: Unknown
• Conditions: Infection
• Intervention / Treatment: Drug: IL-2

Detailed Description

We are going to conduct a multi-center prospective observational study, and plan to enroll 500 SLE patients. Low-dose IL-2 is defined as 100IU IL-2 injected subcutaneously every other day for two weeks, followed by two-week break as one treatment cycle, and at least three weeks.There will be 250 patients in low-dose IL-2 group which treat with IL-2 combined with steroid and immunosuppressor. Non-IL-2 group is only treat with steroid and immunosuppressor. These patients are followed by every one month until get infected, otherwise, patients will be followed for two years. We focus on the type, positive microorganisms, grade and treatment of infection. Then, we will compare the differences of above parameters between these two groups.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Jiali Chen, MD; Phone Number: +8618801206400; Email: chenjiali0389@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking Universtiy People's Hospital
      • Contact: Jiali Chen, MD; Phone Number: +8618801206400; Email: chenjiali0389@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Depending on the incidence of infection in our retrospective study, Low-dose IL-2 group was 14.1%, non-IL-2 group was 25.2%. α was 0.05, β was 0.2, After the calculation of sample size, with the addition of about 20% patients for loss of follow-up, we plan to enroll 500 patients, and 250 patients in every groups equally.

Description

Inclusion Criteria:

• SLE patients diagnosed by the ACR Criteria of 1987;
• Treated with low-dose IL-2, corticosteroid and immunosuppressor for SLE.
• Consent to participate in this study.
• Regular follow-up for at least 2 years.

Exclusion Criteria:

• Other autoimmune disease;
• Without treatment of low-dose IL-2, corticosteroid and immunosuppressor for SLE.
• Mental disorder without regular or specific treatment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low-dose IL-2 group; Patients in this group were treated with low-dose IL-2 combined with corticosteroid and immunosuppressor, and low-dose IL-2 is defined as 100IU subcutaneously every other day for two weeks, followed by two-week break, as one treatment cycle, and at least three cycles.	Drug: IL-2; IL-2 is a medicine which can use in autoimmune disease, infection or cancer with different dose. Low-dose IL-2 preferentially used in autoimmune disease, such as SLE. Our enrolled SLE patients will divided into two groups depend on whether use IL-2 or not, combined with corticosteroid and immunosuppressor.
Non IL-2 group; Patients in this group were only treated with corticosteroid and immunosuppressor,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of infection of two groups	Infection is confirmed by art least one infectious specialist or rheumatologist, by means of clinical symptoms, positive microorganisms culture, response to antibiotic therapy.	2 years

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Zhanguo Li, PhD,MD, Department of Rheumatology and Immunology, Peking University People's Hospital

Publications and helpful links

General Publications

• He J, Zhang X, Wei Y, Sun X, Chen Y, Deng J, Jin Y, Gan Y, Hu X, Jia R, Xu C, Hou Z, Leong YA, Zhu L, Feng J, An Y, Jia Y, Li C, Liu X, Ye H, Ren L, Li R, Yao H, Li Y, Chen S, Zhang X, Su Y, Guo J, Shen N, Morand EF, Yu D, Li Z. Low-dose interleukin-2 treatment selectively modulates CD4(+) T cell subsets in patients with systemic lupus erythematosus. Nat Med. 2016 Sep;22(9):991-3. doi: 10.1038/nm.4148. Epub 2016 Aug 8.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: IL2Pro-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No