DOSE-DEPENDENT EFFICACY AND SAFETY OF LOW-DOSE IL-2 IN THE TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS
Bibliographic record
Abstract
O008 / #335 Topic: AS24 - SLE-Treatment ABSTRACT CONCURRENT SESSION 01: FINDINGS FROM LUPUS CLINICAL TRIALS 22-05-2025 1:40 PM - 2:40 PM Background/Purpose Interleukin-2 (IL-2) has shown potential in immune modulation for autoimmune diseases, esp. systemic lupus erythematosus (SLE). This study investigates the dose-dependent (at different dose levels) efficacy and safety of IL-2 in patients with active SLE, aiming to determine the optimal dose for balancing therapeutic efficacy with tolerability. Methods In this multicenter, randomized, double-blind, placebo-controlled phase IIb study, we enrolled SLE patients who were randomized (1:1:1:1) to receive IL-2 at doses of 0.2 M, 0.5 M, or 1 M IU, or placebo for 12 weeks, followed by weekly the same dosing for another 12 weeks. The primary endpoint was the SLE Responder Index-4 (SRI-4) at week 24, with secondary endpoints assessing Treg expansion, safety, and clinical parameters across different dose groups. Results Between Septemper 2019 and July 2024, a total of 152 patients were randomized in a 1:1:1:1 ratio to receive IL-2 at different doses: 0.2 M IU (n=38), 0.5 M IU (n=38), 1 M IU (n=37), or placebo (n=39). At week 24, SRI-4 response rates were 87.9%, 79.4%, and 62.9% for the 1 million IU, 0.5 million IU, and 0.2 million IU groups, respectively, compared to 44.1% for placebo. Significantly higher patients achieved Lupus Low Disease Activity State (LLDAS) and improvements in Physician’s Global Assessment (PGA) scores were also observed. Secondary end points with respect to mucocutaneous, musculoskeletal, and hematological involvement also showed a significant benefit with Ld-IL2. Patients in 1 M IU exhibited significant expansion of Treg cells and reduced glucocorticoid usage, compared to lower doses and placebo. The safety profile across all IL-2 groups was favorable with fewer infection complications reported, including upper respiratory tract infection and urinary tract infection. At week 24, the 1 M IU IL2 group showed significantly more patients achieving improvement than the placebo group Conclusions This study demonstrated a dose-dependent response with Ld-IL2 in reducing disease activity in SLE, particularly with the 1 million IU dose, which showed optimal clinical and immunological benefits.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".