Drug updated on 4/18/2024
| Dosage Form | Injection (intravenous; 1,100 mg/22 mL [50 mg/mL] in a single-dose vial) |
| Drug Class | Classical complement inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).
Summary
- Sutimlimab-jome (Enjaymo) is indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD). It selectively inhibits C1s of the C1 complex, preventing classical complement pathway activation without affecting alternative and lectin pathways.
- Three randomized controlled trials focused on sutimlimab-jome's efficacy and safety profile. These included the CARDINAL study parts A & B, as well as the CADENZA trial.
- In these studies, sutimlimab-jome showed rapid effects on halting hemolysis and improving anemia over a median of 144 weeks. Improvements in hemoglobin levels, bilirubin levels, and FACIT-Fatigue scores were noted with sustained effects.
- Sutimlimab-jome was generally well-tolerated across all trials. Common treatment-emergent adverse events included infections but did not include systemic lupus erythematosus or meningococcal infections. Other side effects like headache, hypertension, and rhinitis, though more frequent compared to placebo groups, were manageable.
- Upon cessation of sutimlimab-jome treatment, most adverse events observed aligned with recurrence of CAD symptoms, indicating ongoing treatment necessity for effective condition management.
- While direct comparisons within studies are lacking due to specificity of its mechanism and rarity of CAD, significant improvements in hematologic parameters along with a favorable safety profile position it as a potentially important advancement in managing this disease. This suggests broad applicability within the patient population suffering from a wide range of CAD severity, irrespective of recent transfusion history.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Enjaymo (sutimlimab-jome) Prescribing Information. | 2022 | Bioverativ USA Inc., Waltham, MA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Sustained inhibition of complement C1s with sutimlimab over 2 years in patients with cold agglutinin disease. | 22Subjects F: 68% M: 32% | 2023 | American Journal of Hematology |
| Sutimlimab provides clinically meaningful improvements in patient-reported outcomes in patients with cold agglutinin disease: Results from the randomised, placebo-controlled, phase 3 CADENZA study. | 42Subjects F: 79% M: 21% | 2023 | European Journal of Hematology |
| Sutimlimab in patients with cold agglutinin disease: Results of the randomized placebo-controlled phase 3 CADENZA trial. | 42Subjects F: 78.57% M: 21.43% | 2022 | Blood |
Document Title
Sex Distribution:
F:68%
M:32%
22Subjects
Year:
2023
Source:American Journal of Hematology
Sex Distribution:
F:79%
M:21%
42Subjects
Year:
2023
Source:European Journal of Hematology
Document Title
Sex Distribution:
F:78.57%
M:21.43%
42Subjects
Year:
2022
Source:Blood