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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Firsekibart 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.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
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)
Time frame: From enrollment to the end of treatment at 12 weeks
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)
Time frame: From enrollment to the end of treatment at 24 weeks
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).
Time frame: From enrollment to the end of treatment at 12 weeks
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).
Time frame: From enrollment to the end of treatment at 24 weeks
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
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline in SLEDAI at 12 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
Time frame: From enrollment to the end of treatment at 12 weeks
Changes from baseline in PGA at 24 weeks
PGA stands for Physician's Global Assessment (PGA ) . It is used to assess the activity of systemic lupus erythematosus on a scale ranging from 0 to 3, where 0 indicates no disease activity and 3 indicates the most severe disease activity.
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline in PGA at 12 weeks
PGA stands for Physician's Global Assessment (PGA ) . It is used to assess the activity of systemic lupus erythematosus on a scale ranging from 0 to 3, where 0 indicates no disease activity and 3 indicates the most severe disease activity.
Time frame: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the SJC and TJC at 24 weeks
Swollen Joint Count(SJC) and Tender Joint Count(TJC) indicate the number of swollen and tender joints in 28 joints, respectively. 28 joints refer to both shoulders, both elbows, both wrists, both knees, 10 metacarpophalangeal joints, and 10 proximal interphalangeal joints, which ranging from 0 to 28, the higher value means more serious disease activity.
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the SJC and TJC at 12 weeks
Swollen Joint Count(SJC) and Tender Joint Count(TJC) indicate the number of swollen and tender joints in 28 joints, respectively. 28 joints refer to both shoulders, both elbows, both wrists, both knees, 10 metacarpophalangeal joints, and 10 proximal interphalangeal joints, which ranging from 0 to 28, the higher value means more serious disease activity.
Time frame: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the levels of Erythrocyte Sedimentation Rate (ESR) at 24 weeks
The erythrocyte sedimentation rate (ESR) is used to indicate the level of inflammation. In this study, the normal range is 0-15 mm/h. A value exceeding the upper limit of normal indicates an elevated level of inflammation, with higher values suggesting a greater degree of inflammation.
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the levels of Erythrocyte Sedimentation Rate (ESR) at 12 weeks
The erythrocyte sedimentation rate (ESR) is used to indicate the level of inflammation. In this study, the normal range is 0-15 mm/h. A value exceeding the upper limit of normal indicates an elevated level of inflammation, with higher values suggesting a greater degree of inflammation.
Time frame: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the CLASI score at 24 weeks
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) was used in this study to evaluate disease activity and lesion severity in cutaneous SLE involvement. Scores of 0-9 indicate mild disease, 10-20 moderate disease, and 21-70 severe disease.
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the CLASI score at 12 weeks
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) was used in this study to evaluate disease activity and lesion severity in cutaneous SLE involvement. Scores of 0-9 indicate mild disease, 10-20 moderate disease, and 21-70 severe disease.
Time frame: From enrollment to the end of treatment at 12 weeks
Changes from baseline of the levels of C-Reaction Protein (CRP) at 24 weeks
The c-reaction protein (CRP) is used to indicate the level of inflammation. In this study, the normal range is 0-10 mg/L. A value exceeding the upper limit of normal indicates an elevated level of inflammation, with higher values suggesting a greater degree of inflammation.
Time frame: From enrollment to the end of treatment at 24 weeks
Changes from baseline of the levels of C-Reaction Protein (CRP) at 12 weeks
The c-reaction protein (CRP) is used to indicate the level of inflammation. In this study, the normal range is 0-10 mg/L. A value exceeding the upper limit of normal indicates an elevated level of inflammation, with higher values suggesting a greater degree of inflammation.
Time frame: From enrollment to the end of treatment at 12 weeks
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