This is a prospective, single-arm, open-lable, single-center study and we aimed to determine whether atorvastatin combined with N-acetyl-L-cysteine (NAC) plus romiplostim could induce sustained response off-treatment (SRoT) in adult patients with ITP following CS failure.
Diagnosed with primary ITP;
Aged ≥18 years;
Patients with treatment failure or relapse after first-line corticosteriod therapy for ITP;
Platelet count <30×10⁹/L.
Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;
Presence of active malignant tumors;
Active HBV, HCV or HIV infection;
Active infection requiring systematic treatment;
Single group
atorvastatin, NAC, and romiplostim
DrugFrom Week 1 to Week 24, atorvastatin and NAC was administrated as the dose of 20mg qd and 400mg tid,respectively, and were discontinued at the end of Week 24. For romiplostim, the initial dose was 3 μg/kg per week. The weekly dose was adjusted based on platelet counts, with a maximum dose of 10 μg/kg per week, to maintain platelet levels within the range of 100-200×10⁹/L during the initial 24-week period. From Week 25 to Week 35, romiplostim was gradually tapered and discontinued with the goal of maintaining a platelet count ≥30×10⁹/L and no less than twice the baseline level. After all medications (including atorvastatin, NAC, and romiplostim) were discontinued (no later than Week 36), patients were followed up for an additional 24 weeks to evaluate the sustained response rate at 24 weeks post-treatment cessation.
24-week SRoT rate
Sustained response off-treatment (SRoT) rate is defined as the proportion of patients who maintain a platelet count ≥30×10\^9/L and at least a two-fold increase from the baseline count without active bleeding following treatment discontinuation.
24-week SCRoT rate
Sustained complete response off-treatment (SCRoT) rate was defined as the proportion of patients who maintain a platelet count of ≥100×10⁹/L without active bleeding after treatment discontinuation.
ORR
Overall response rate (ORR) is defined as the proportion of patients who achieve platelet count ≥30×10\^9/L and more than twice the baseline level, with no signs of active bleeding.
CR rate
Complete response (CR) rate is defined as the proportion of patients who achieve a platelet count ≥100×10⁹/L with no signs of active bleeding.
TTR
Time to response (TTR) is defined as the days from treatment initiation to first platete count reaching ≥30×10\^9/L
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