Systemic lupus erythematosus (SLE) is a systemic autoimmune disorder in which pro-inflammatory factors of the IL-1 family play a pivotal role in its pathogenesis. In SLE patients, an innate immune hyperreactivity coupled with excessive inflammasome activation leads to substantial IL-1β production, triggering inflammatory phenotypes such as fever and serositis. For SLE patients unresponsive to conventional therapies, particularly those exhibiting high fever and serositis indicative of innate immune overactivation, effective targeted treatments remain scarce. Firsekibart, as a first anti-IL-1β biologic, holds promise in delivering novel therapeutic benefits for SLE patients with high-inflammatory phenotypes who prove refractory to standard therapies.
Aged 18 to 65 years, male or female; female participants must not be pregnant or breastfeeding and must agree to use effective contraception during the trial period.
Meets the 2012 SLICC classification criteria for SLE or the 2019 ACR/EULAR classification criteria for SLE;
Mild to moderate disease activity, 1 point ≤ SLEDAI ≤ 12 points (cSLEDAI ≠ 0);
The presence of at least one of the following recent clinical manifestations: fever (excluding fever caused by infection, tumor, endocrine or metabolic disorders, central nervous system diseases, medications, or physical factors), serositis (such as pericarditis or pleurisy), arthritis, rash, or alopecia;
SLE with major organ dysfunction, including impaired consciousness, cognitive decline, renal insufficiency, cardiac insufficiency (NYHA class 3 or 4), pulmonary hypertension, and pulmonary interstitial disease.
Active SLE organ involvement, including but not limited to active lupus encephalopathy, active lupus nephritis (proteinuria ≥1g/24h), cardiac involvement, gastrointestinal involvement, diffuse alveolar haemorrhage, thrombocytopenic purpura, hemophagocytic syndrome, and retinopathy.
SLE coexisting with other autoimmune diseases potentially affecting efficacy assessment, including but not limited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal; total bilirubin (TBIL) > 1 times the upper limit of normal.
Single group
Firsekibart
DrugFirsekibart combined with standard therapy: subcutaneous injection of 200mg Firsekibart at weeks 0, 4 and 8. Discontinue Firsekibart at weeks 12-24, with all other standard treatments unchanged. Observe for recurrence; if recurrence occurs, patients will be removed from the group and receive additional medication.
the percentage of patients achieving an BICLA response at the end of 12 weeks
The BICLA response was defined as a reduction of all severe (BILAG-2004 A) or moderately severe (BILAG-2004 B) disease activity at baseline to lower levels (BILAG-2004 B, C, or D and C or D, respectively) and no worsening in other organ systems (with worsening defined as ≥1 new BILAG-2004 A item or ≥2 new BILAG-2004 B items); no worsening in disease activity, as determined by the SLEDAI-2K score (no increase from baseline) and by the PGA score (no increase of ≥0.3 points from baseline)
the percentage of patients achieving an BICLA response at the end of 24 weeks
The BICLA response was defined as a reduction of all severe (BILAG-2004 A) or moderately severe (BILAG-2004 B) disease activity at baseline to lower levels (BILAG-2004 B, C, or D and C or D, respectively) and no worsening in other organ systems (with worsening defined as ≥1 new BILAG-2004 A item or ≥2 new BILAG-2004 B items); no worsening in disease activity, as determined by the SLEDAI-2K score (no increase from baseline) and by the PGA score (no increase of ≥0.3 points from baseline)
the percentage of patients achieving SRI-4 response at the end of 12 weeks.
The SRI-4（SLE Responder Index-4） response was defined as a reduction of at least 4 points in SLEDAI score compared with the baseline level, no new British Isles Lupus Assessment Group (BILAG) A organ domain score or no more than one new BILAG B organ domain score, and no worsening in the Physician's Global Assessment (PGA) (\<0.3 points worsening from the baseline level).
the percentage of patients achieving SRI-4 response at the end of 24 weeks.
The SRI-4（SLE Responder Index-4） response was defined as a reduction of at least 4 points in SLEDAI score compared with the baseline level, no new British Isles Lupus Assessment Group (BILAG) A organ domain score or no more than one new BILAG B organ domain score, and no worsening in the Physician's Global Assessment (PGA) (\<0.3 points worsening from the baseline level).
Changes from baseline in SLEDAI at 24 weeks
SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index, with a score of 0-6 representing mild disease activity, 7-12 representing moderate disease activity, and 12-16 representing severe disease activity
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