ENJAYMO SIDE EFFECTS
- Generic Name: sutimlimab-jome injection
- Brand Name: Enjaymo
- Drug Class: IMMUNOMODULATORS
SIDE EFFECTS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Serious Infections
- Infusion-Related Reactions
- Risk of Autoimmune Disease
- Recurrent Hemolysis After ENJAYMO Discontinuation
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ENJAYMO in patients with a confirmed diagnosis of CAD and history of blood transfusion in the 6 months prior to study enrollment was evaluated in a six-month, open-label single-arm trial (CARDINAL) (n=24) [see CLINICAL PHARMACOLOGY]. The median duration of treatment was 26.1 weeks and 92% completed 26 weeks of therapy.
In CARDINAL, the most common adverse reactions occurring in ≥10% of patients were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis and peripheral edema. Serious adverse reactions were reported in 13% (3/24) of patients who received ENJAYMO. These serious adverse reactions were streptococcal sepsis and staphylococcal wound infection (n=1), arthralgia (n=1), and respiratory tract infection (n=1). None of the adverse reactions led to discontinuation of ENJAYMO in CARDINAL. Dosage interruptions due to an adverse reaction occurred in 17% (4/24) of patients who received ENJAYMO.
Adverse reactions occurring in ≥5% or more patients in CARDINAL are summarized in Table 2.
Table 1: Adverse Reactions (≥5%) in Patients Receiving ENJAYMO in CARDINAL
| Adverse Reaction | n (%) N=24 |
| Infections | |
| Respiratory tract infection*a | 6 (25) |
| Viral infection*b | 3 (13) |
| Urinary tract infection*c | 2 (8) |
| Bacterial infection*d | 2 (8) |
| Vascular disorders | |
| Cyanosis | 2 (8) |
| Systemic hypertensione | 2 (8) |
| Gastrointestinal disorders | |
| Diarrhea | 3 (13) |
| Dyspepsiaf | 3 (13) |
| Gastroenteritis | 2 (8) |
| Abdominal pain | 2 (8) |
| Respiratory, thoracic and mediastinal disorders | |
| Coughg | 2 (8) |
| Musculoskeletal and connective tissue disorders | |
| Arthralgia, arthritis*h | 3 (13) |
| General disorders and administration site conditions | |
| Peripheral edema | 3 (13) |
| Fatigue*i | 2 (8) |
| Infusion reaction | 2 (8) |
| Nervous system disorders | |
| Headache | 2 (8) |
| * Events may be counted in more than one grouped term, e.g., viral upper respiratory tract infection is counted in viral infection and respiratory tract infection. The following terms were combined: a Includes nasopharyngitis, respiratory tract infection, respiratory tract infection viral, upper respiratory tract infection, viral upper respiratory tract infection b Includes oral herpes, respiratory tract infection viral, viral infection, viral upper respiratory tract infection c Includes cystitis bacterial, urinary tract infection d Includes cystitis bacterial, streptococcal sepsis, wound infection staphylococcal e Includes hypertension, blood pressure increased f Ipncludes dyspepsia, abdominal pain upper g Includes cough, productive cough h Includes arthralgia, osteoarthritis i Includes fatigue and mental fatigue |
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Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibodies) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with incidence of antibodies in other studies may be misleading.
Immunogenicity of sutimlimab-jome was assessed in CAD patients in CARDINAL at baseline, during the treatment period, and at end of treatment (Week 26). None of the 24 patients enrolled in CARDINAL who received at least one dose of sutimlimab-jome developed treatmentemergent antidrug antibodies (ADAs).
SRC: NLM .