Trial Outcomes & Findings for Low-dose IL-2( Interleukin-2) Treatment in SLE (NCT NCT02084238)

Results Overview

SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

week 2，week 4，week 6，week 8，week 10

Results posted on

2020-04-03

Participant Flow

Between August 2013 and May 2014,38 patients completed three cycles of recombinant human IL-2 (rhIL-2) in Dept. of Rheumatology and Immunology, Peking University People's Hospital. Patients were permitted changes in background therapy according to the treating physician's advice.

All the patients showed poor efficacy at least 4 weeks of stable routine treatment at the time of enrollment. Two of the enrolled patients withdrew from the study at week 8: one changed to the belimumab treatment by personal preference; the other elected changed to the cyclophosphamide treatment to reduce the frequency of hospital visits.

Participant milestones

Participant milestones
Measure	Interleukin-2 Interleukin-2 to treat activated SLE. Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day break, another cycle started) for 3-6 courses according to the situation of the disease.
Overall Study STARTED	40
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Interleukin-2 Interleukin-2 to treat activated SLE. Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day break, another cycle started) for 3-6 courses according to the situation of the disease.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Low-dose IL-2( Interleukin-2) Treatment in SLE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interleukin-2 n=38 Participants Interleukin-2 to treat activated SLE. Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31 years n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment China	38 partiipants n=5 Participants
SELENA-SLEDAI score	11.35 score STANDARD_DEVIATION 3.71 • n=5 Participants

PRIMARY outcome

Timeframe: week 2，week 4，week 6，week 8，week 10

SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.

Outcome measures

Outcome measures
Measure	SRI Results n=38 Participants All 38 patients who completed therapy will be calculated the response rate at each visit time point(week 2,4,6,8,10).	Immunological Responses 2 Tfh cells in CD4+ T cells in 23 patients with SLE	Immunological Responses 3 Th17 in CD4+T cells in 23 patients with SLE
Number of Participants Who Were SLE Responders (SRI) Week 2	12 participants	—	—
Number of Participants Who Were SLE Responders (SRI) Week4	27 participants	—	—
Number of Participants Who Were SLE Responders (SRI) Week 6	33 participants	—	—
Number of Participants Who Were SLE Responders (SRI) week 8	34 participants	—	—
Number of Participants Who Were SLE Responders (SRI) week 10	34 participants	—	—

SECONDARY outcome

Timeframe: week 0 and week 10

Population: regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells

Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study.

Outcome measures

Outcome measures
Measure	SRI Results n=23 Participants All 38 patients who completed therapy will be calculated the response rate at each visit time point(week 2,4,6,8,10).	Immunological Responses 2 n=23 Participants Tfh cells in CD4+ T cells in 23 patients with SLE	Immunological Responses 3 n=23 Participants Th17 in CD4+T cells in 23 patients with SLE
Immunological Responses Week 0	10.6 Percentage of CD4+ T cells Interval 3.54 to 17.6	3.93 Percentage of CD4+ T cells Interval 1.27 to 15.14	4.09 Percentage of CD4+ T cells Interval 1.69 to 11.18
Immunological Responses Week 10	17.5 Percentage of CD4+ T cells Interval 4.76 to 28.2	2.1 Percentage of CD4+ T cells Interval 0.69 to 7.55	2.63 Percentage of CD4+ T cells Interval 1.24 to 7.06

SECONDARY outcome

Timeframe: week 0 and week 10

Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.

Outcome measures

Outcome measures
Measure	SRI Results n=38 Participants All 38 patients who completed therapy will be calculated the response rate at each visit time point(week 2,4,6,8,10).	Immunological Responses 2 n=38 Participants Tfh cells in CD4+ T cells in 23 patients with SLE	Immunological Responses 3 n=38 Participants Th17 in CD4+T cells in 23 patients with SLE
The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients Week 0	0.42 g/L Interval 0.118 to 1.46	0.075 g/L Interval 0.017 to 0.54	417.9 g/L Interval 10.0 to 3987.5
The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients Week 10	0.75 g/L Interval 0.45 to 1.23	0.157 g/L Interval 0.11 to 0.37	105.1 g/L Interval 17.14 to 2467.7

SECONDARY outcome

Timeframe: week 0, week 10

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, score\> 8 means the disease is moderate-to-severe active".

Outcome measures

Outcome measures
Measure	SRI Results n=38 Participants All 38 patients who completed therapy will be calculated the response rate at each visit time point(week 2,4,6,8,10).	Immunological Responses 2 Tfh cells in CD4+ T cells in 23 patients with SLE	Immunological Responses 3 Th17 in CD4+T cells in 23 patients with SLE
SELENA SLEDAI Score Week 0	11.35 score Standard Deviation 3.71	—	—
SELENA SLEDAI Score Week 10	3.775 score Standard Deviation 2.27	—	—

SECONDARY outcome

Timeframe: 24 weeks

Relapses mean that if the patient's SELENA SLEDAI Score is lower than 4 during the treatment, while the SELENA SLEDAI Score increase after stopping using the study drugs in 3 months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to Day 180

Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.

Outcome measures

Outcome data not reported

Adverse Events

IL-2 Therapy in SLE

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IL-2 Therapy in SLE n=38 participants at risk All enrolled patients completed three cycles of recombinant human IL-2 (rhIL-2). In each cycle, 1 million IU rhIL-2 was administered subcutaneously every other day for 2 weeks, followed by a 2-week break.
Skin and subcutaneous tissue disorders Injection-site reaction	13.2% 5/38 • Number of events 5 • 3 months No serious adverse events occurred.
General disorders Fatigue	2.6% 1/38 • Number of events 1 • 3 months No serious adverse events occurred.
General disorders Fever	2.6% 1/38 • Number of events 1 • 3 months No serious adverse events occurred.

Additional Information

Dr. Jing He

Peking University People's Hospital

Phone: 86

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place