.2% (15/182) patients, including 5.5% (10/182) patients who required systemic corticosteroid therapy and 2.7% (5/182) patients who required only hormone replacement therapy. Seven patients (3.8%) received an oral prednisone dose equivalent to >40 mg daily for an immune-mediated adverse reaction [see WARNINGS AND PRECAUTIONS (5)].
Table 2 summarizes the adverse reactions that occurred in ≥10% of patients, while Table 3 summarizes the Grade 3 − 4 selected laboratory abnormalities that occurred in ≥1% of patients treated with IMFINZI in Study 1.
Table 2. Adverse Reactions in ≥10% of Patients in UC Cohort Study 1
IMFINZI
N=182
Adverse Reaction All Grades
(%) Grades 3 – 4
(%)
All Adverse Reactions
96
43
Gastrointestinal Disorders
Constipation
21
1
Nausea
16
2
Abdominal pain1
14
3
Diarrhea/Colitis
13
1
General Disorders and Administration
Fatigue2
39
6
Peripheral edema3
15
2
Pyrexia/Tumor associated fever
14
1
Infections
Urinary tract infection4
15
4
Metabolism and Nutrition Disorders
Decreased appetite/Hypophagia
19
1
Musculoskeletal and Connective Tissue Disorders
Musculoskeletal pain5
24
4
Respiratory, Thoracic, and Mediastinal Disorders
Dyspnea/Exertional Dyspnea
13
2
Cough/Productive Cough
10
0
Skin and Subcutaneous Tissue Disorders
Rash6
11
1
1 Includes abdominal pain upper, abdominal pain lower and flank pain
2 Includes asthenia, lethargy, and malaise
3 Includes edema, localized edema, edema peripheral, lymphedema, peripheral swelling, scrotal edema, and scrotal swelling
4 Includes cystitis, candiduria and urosepsis
5 Includes back pain, musculoskeletal chest pain, musculoskeletal pain and discomfort, myalgia, and neck pain
6 Includes dermatitis, dermatitis acneiform, dermatitis psoriasiform, psoriasis, rash maculo-papular, rash pruritic, rash papular, rash pustular, skin toxicity, eczema, erythema, erythema multiforme, rash erythematous, acne, and lichen planus
Table 3. Grade 3-4 Laboratory Abnormalities Worsened from Baseline Occurring in ≥1% Patients in UC Cohort Study 1
Laboratory Test
Grade 3 - 4
%
Hyponatremia
12
Lymphopenia
11
Anemia
8
Increased alkaline phosphatase
4
Hypermagnesemia
4
Hypercalcemia
3
Hyperglycemia
3
Increased AST
2
Increased ALT
1
Hyperbilirubinemia
1
Increased creatinine
1
Neutropenia
1
Hyperkalemia
1
Hypokalemia
1
Hypoalbuminemia
1
6.2 Immunogenicity
As with all therapeutic proteins, there is a 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 antibody) 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 to IMFINZI to the incidence of antibodies to other products may be misleading.
Due to the limitations in assay p
