ACN_7.14_Full Issue digital | Page 7

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Charlie M . Wray , DO , MS
@ WrayCharles
If anyone is curious as to when and where my hospital will be using a leaf-blower , it ’ s usually when I have to give a talk and right outside my office window , so ...
PS . They know to stop after I ’ m done with my presentation though
Elin Roddy , MD
@ elinlowri
Just started to write my own name on a death certificate how ’ s your day going
Nicole Kucine , MD , MS
@ PedsHemeDoc
in hematology we don ’ t say “ I love you ” we say “ I picked up your patient ’ s smear for you when I stopped by the lab to get mine ” and I think that ’ s beautiful
IMBRUVICA ® ( ibrutinib ) IMBRUVICA ® ( ibrutinib )
Table 1 : Non-Hematologic Adverse Reactions in ≥ 10 % of Patients with CLL / SLL ( N = 51 ) in Study 1102
Body System
Adverse Reaction
All Grades (%)
Gastrointestinal
Diarrhea
59
4
disorders
Constipation
22
2
Nausea
20
2
Stomatitis
20
0
Vomiting
18
2
Abdominal pain
14
0
Dyspepsia
12
0
Skin and
Bruising
51
2
subcutaneous tissue
Rash
25
0
disorders
Petechiae
16
0
Infections and
Upper respiratory
infestations
tract infection
47
2
Sinusitis
22
6
Skin infection
16
6
Pneumonia
12
10
Urinary tract
12
2
infection
General disorders and
Fatigue
33
6
administration site
Pyrexia
24
2
conditions
Peripheral edema
22
0
Asthenia
14
6
Chills
12
0
Musculoskeletal and
Musculoskeletal pain
25
6
connective tissue
Arthralgia
24
0
disorders
Muscle spasms
18
2
Respiratory , thoracic
Cough
22
0
and mediastinal
Oropharyngeal pain
14
0
disorders
Dyspnea
12
0
Nervous system
Dizziness
20
0
disorders
Headache
18
2
Vascular disorders
Hypertension
16
8
Decreased appetite
16
2
Metabolism and nutrition disorders
Grade 3 or Higher (%)
Neoplasms benign , malignant , unspecified
Second malignancies
10
2 †
† One patient death due to histiocytic sarcoma .
Table 2 : Treatment-Emergent * Hematologic Laboratory Abnormalities
in Patients with CLL / SLL ( N = 51 ) in Study 1102
Percent of Patients ( N = 51 )
All Grades (%)
Grade 3 or 4 (%)
Platelets decreased
69
12
Neutrophils decreased
53
26
Hemoglobin decreased
43
0
* Based on laboratory measurements per IWCLL criteria and adverse reactions .
Treatment-emergent Grade 4 thrombocytopenia ( 8 %) and neutropenia ( 12 %)
occurred in patients .
RESONATE : Adverse reactions and laboratory abnormalities described
below in Tables 3 and 4 reflect exposure to IMBRUVICA with a median
duration of 8.6 months and exposure to ofatumumab with a median of
5.3 months in RESONATE in patients with previously treated CLL / SLL .
Table 3 : Adverse Reactions Reported in ≥ 10 % of Patients in the IMBRUVICA
Treated Arm in Patients with CLL / SLL in RESONATE
IMBRUVICA
Ofatumumab
( N = 195 )
( N = 191 )
All Grades (%)
Grade 3 or Higher (%)
All Grades (%)
Grade 3 or Higher (%)
Body System Adverse Reaction
Gastrointestinal disorders
Diarrhea
48
4
18
2
Nausea
26
2
18
0
Stomatitis *
17
1
6
1
Constipation
15
0
9
0
Vomiting
14
0
6
1
Table 3 : Adverse Reactions Reported in ≥ 10 % of Patients in the IMBRUVICA Treated Arm in Patients with CLL / SLL in RESONATE ( continued )
Body System Adverse Reaction
IMBRUVICA ( N = 195 )
All Grades (%)
Grade 3 or 4 (%)
Ofatumumab ( N = 191 )
All Grades (%)
Grade 3 or 4 (%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain *
28
2
18
1
Arthralgia
17
1
7
0
Muscle spasms
13
0
8
0
Skin and subcutaneous tissue disorders
Rash *
24
3
13
0
Petechiae
14
0
1
0
Bruising *
12
0
1
0
General disorders and administration site conditions
Pyrexia
24
2
15
2 †
Respiratory , thoracic and mediastinal disorders
Cough
19
0
23
1
Dyspnea
12
2
10
1
Infections and infestations Upper respiratory tract
16
1
11
2 †
infection
Pneumonia *
15
12 †
13
10 †
Sinusitis *
11
1
6
0
Urinary tract infection
10
4
5
1
Nervous system disorders Headache
14
1
6
0
Dizziness
11
0
5
0
Injury , poisoning and procedural complications
Contusion
11
0
3
0
Eye disorders Vision blurred
10
0
3
0
The body system and individual ADR terms are sorted in descending frequency
order in the IMBRUVICA arm .
* Includes multiple ADR terms
† Includes 3 events of pneumonia with fatal outcome in each arm , and 1 event
of pyrexia and upper respiratory tract infection with a fatal outcome in the
ofatumumab arm .
Table 4 : Treatment-Emergent Hematologic Laboratory Abnormalities in Patients with CLL / SLL in RESONATE
IMBRUVICA ( N = 195 )
All Grades (%)
Grade 3 or 4 (%)
Ofatumumab ( N = 191 )
All Grades (%)
Grade 3 or 4 (%)
Neutrophils decreased 51 23 57 26 Platelets decreased 52 5 45 10 Hemoglobin decreased 36 0 21 0
Treatment-emergent Grade 4 thrombocytopenia ( 2 % in the IMBRUVICA arm vs 3 % in the ofatumumab arm ) and neutropenia ( 8 % in the IMBRUVICA arm vs 8 % in the ofatumumab arm ) occurred in patients .
RESONATE-2 : Adverse reactions and laboratory abnormalities described below in Tables 5 and 6 reflect exposure to IMBRUVICA with a median duration of 17.4 months . The median exposure to chlorambucil was 7.1 months in RESONATE-2 .