ASH Clinical News ACN_5.2_digital | Page 31

CLINICAL NEWS
REACHing Children With Sickle Cell Anemia in
Sub-Saharan Africa
Léon Tshilolo, MD, PhD, at the plenary session.
Daily treatment with hydroxyurea was
feasible, well-tolerated, and safe for
children with sickle cell anemia (SCA)
living in sub-Saharan Africa, according
to results from the Realizing Effective-
ness Across Continents with Hydroxyurea
(REACH) trial presented as a plenary
abstract at the 2018 ASH Annual Meeting.
This is the largest prospective trial
of hydroxyurea in this population, and
“based on these data, we believe that
wider access to hydroxyurea for SCA has
REVLIMID [lenalidomide] capsules, for oral use
Table 4: All Adverse Reactions in ≥5.0% and Grade 3/4 Adverse Reactions in ≥ 1.0% of Patients in the Rd Continuous or Rd18 Arms*
All Adverse Reactions a
Grade 3/4 Adverse Reactions b
Rd
Continuous
(N = 532) Rd18
(N = 540) MPT
(N = 541) Anemia 233 (43.8) 193 (35.7) 229 (42.3) 97 ( 18.2) 85 ( 15.7) 102 (18.9)
Neutropenia 186 (35.0) 178 (33.0) 328 (60.6) 148 ( 27.8) 143 (26.5) 243 (44.9)
Thrombocytopenia 104 (19.5) 100 (18.5) 135 (25.0) 44 ( 8.3) 43 ( 8.0) 60 (11.1)
Febrile neutropenia 7 ( 1.3) 17 ( 3.1) 15 ( 2.8) 6 ( 1.1) 16 ( 3.0) 14 ( 2.6)
Pancytopenia 5 ( 0.9) 6 ( 1.1) 7 ( 1.3) 1 ( 0.2) 3 ( 0.6) 5 ( 0.9)
Cough f 121 (22.7) 94 (17.4) 68 (12.6) < 1% < 1% < 1%
Dyspnea c,e 117 (22.0) 89 (16.5) 113 (20.9) 30 ( 5.6) 22 ( 4.1) 18 ( 3.3)
Epistaxis f 32 ( 6.0) 31 ( 5.7) 17 ( 3.1) < 1% < 1% 0 ( 0.0)
Oropharyngeal pain f 30 ( 5.6) 22 ( 4.1) 14 ( 2.6) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0)
Dyspnea exertional e 27 ( 5.1) 29 ( 5.4) < 5% 6 ( 1.1) 2 ( 0.4) 0 ( 0.0)
Body System
Adverse Reaction
Rd
Continuous
(N = 532)
Rd18
(N = 540)
MPT
(N = 541)
Blood and lymphatic system disorders d
Respiratory, thoracic and mediastinal disorders
Metabolism and nutrition disorders
Decreased appetite
123 (23.1) 115 (21.3) 72 (13.3) 14 ( 2.6) 7 ( 1.3) 5 ( 0.9)
Hypokalemia % 91 (17.1) 62 (11.5) 38 ( 7.0) 35 ( 6.6) 20 ( 3.7) 11 ( 2.0)
Hyperglycemia 62 (11.7) 52 ( 9.6) 19 ( 3.5) 28 ( 5.3) 23 ( 4.3) 9 ( 1.7)
Hypocalcemia 57 (10.7) 56 (10.4) 31 ( 5.7) 23 ( 4.3) 19 ( 3.5) 8 ( 1.5)
Dehydration % 25 ( 4.7) 29 ( 5.4) 17 ( 3.1) 8 ( 1.5) 13 ( 2.4) 9 ( 1.7)
Gout e < 5% < 5% < 5% 8 ( 1.5) 0 ( 0.0) 0 ( 0.0)
Diabetes mellitus % e < 5% < 5% < 5% 8 ( 1.5) 4 ( 0.7) 2 ( 0.4)
Hypophosphatemia e < 5% < 5% < 5% 7 ( 1.3) 3 ( 0.6) 1 ( 0.2)
Hyponatremia % e < 5% < 5% < 5% 7 ( 1.3) 13 ( 2.4) 6 ( 1.1)
139 (26.1) 151 (28.0) 105 (19.4) 39 ( 7.3) 38 ( 7.0) 33 ( 6.1)
47 ( 8.8) 49 ( 9.1) 24 ( 4.4) < 1% < 1% < 1%
147 (27.6) 127 (23.5) 53 ( 9.8) 4 ( 0.8) 6 ( 1.1) 0 ( 0.0)
58 (10.9) 46 ( 8.5) 30 ( 5.5) 10 ( 1.9) 4 ( 0.7) 1 ( 0.2)
Deep vein thrombosis c% 55 (10.3) 39 ( 7.2) 22 ( 4.1) 30 ( 5.6) 20 ( 3.7) 15 ( 2.8)
Hypotension c% 51 ( 9.6) 35 ( 6.5) 36 ( 6.7) 11 ( 2.1) 8 ( 1.5) 6 ( 1.1)
Skin and subcutaneous tissue disorders
Rash
Pruritus f
Psychiatric disorders
Insomnia
Depression
Vascular disorders
Injury, Poisoning, and Procedural Complications
Fall f 43 ( 8.1) 25 ( 4.6) 25 ( 4.6) < 1% 6 ( 1.1) 6 ( 1.1)
Contusion f 33 ( 6.2) 24 ( 4.4) 15 ( 2.8) < 1% < 1% 0 ( 0.0)
73 (13.7) 31 ( 5.7) 5 ( 0.9) 31 ( 5.8) 14 ( 2.6) 3 ( 0.6)
< 5% < 5% < 5% 7 ( 1.3) 0 ( 0.0) 0 ( 0.0)
72 (13.5) 78 (14.4) 48 ( 8.9) 11 ( 2.1) 4 ( 0.7) 4 ( 0.7)
37 ( 7.0) 25 ( 4.6) 25 ( 4.6) 13 ( 2.4) 9 ( 1.7) 6 ( 1.1)
< 5% < 5% < 5% 10 ( 1.9) 3 ( 0.6) 5 ( 0.9)
49 ( 9.2) 54 (10.0) 37 ( 6.8) 28 ( 5.3) 33 ( 6.1) 29 ( 5.4)
4 ( 0.7) 0 ( 0.0)
< 1% 0 ( 0.0)
Eye disorders
Cataract
Cataract subcapsular e
Investigations
Weight decreased
Cardiac disorders
Atrial fibrillation c
Myocardial infarction (including acute) c ,e
Renal and Urinary disorders
Renal failure (including acute) c@,f
Neoplasms benign, malignant and unspecified (Incl cysts and polyps)
Squamous cell carcinoma c e < 5% < 5% < 5% 8 ( 1.5)
Basal cell carcinoma c e,f < 5% < 5% < 5% < 1%
Note: A subject with multiple occurrences of an adverse reaction is counted only once under the applicable Body System/Adverse Reaction.
All treatment-emergent adverse reactions in at least 5.0% of subjects in the Rd Continuous or Rd18 Arms and at least a 2.0% higher frequency (%) in either
the Rd Continuous or Rd18 Arms compared to the MPT Arm.
b All grade 3 or 4 treatment-emergent adverse reactions in at least 1.0% of subjects in the Rd Continuous or Rd18 Arms and at least a 1.0% higher frequency
(%) in either the Rd Continuous or Rd18 Arms compared to the MPT Arm.
c Serious treatment-emergent adverse reactions in at least 1.0% of subjects in the Rd Continuous or Rd18 Arms and at least a 1.0% higher frequency (%) in
either the Rd Continuous or Rd18 Arms compared to the MPT Arm.
d Preferred terms for the blood and lymphatic system disorders body system were included by medical judgment as known adverse reactions for
Rd Continuous/Rd18, and have also been reported as serious.
a
Cosmos Communications
1
Q1
Q2
the potential to save millions of lives in
Africa,” lead study author Léon Tshilolo,
MD, PhD, of the Centre Hospitalier
Monkole in Kinshasa in the Democratic
Republic of the Congo, said during his
presentation.