A new dosing regimen of ropeginterferon alfa-2b is highly effective and tolerable: findings from a phase 2 study in Chinese patients with polycythemia vera

Jin, Jie; Zhang, Lei; Qin, Albert; Wu, Daoxiang; Shao, Zonghong; Bai, Jie; Chen, Suning; Duan, Minghui; Zhou, Hu; Xu, Na; Zhang, Sujiang; Zuo, Xuelan; Du, Xin; Wang, Li; Li, Pei; Zhang, Xuhan; Li, Yaning; Zhang, Jingjing; Wang, Wei; Shen, Weihong; Zagrijtschuk, Oleh; Urbanski, Raymond; Sato, Toshiaki; Xiao, Zhijian

doi:10.1186/s40164-023-00415-0

Table 1 Treatment-emergent adverse events (TEAEs) occurring in ≥ 10% of patients

From: A new dosing regimen of ropeginterferon alfa-2b is highly effective and tolerable: findings from a phase 2 study in Chinese patients with polycythemia vera

System organ class Preferred term	Patients (n = 49)^a
	Grade 1	Grade 2	Grade 3^b	Grade 4	Grade 5	Total
	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Metabolism and nutrition disorders
Hyperuricemia	16 (32.7%)	0	0	0	0	16 (32.7%)
Hypertriglyceridemia	9 (18.4%)	0	2 (4.1%)	0	0	11 (22.4%)
Decreased appetite	5 (10.2%)	0	0	0	0	5 (10.2%)
General disorders and administration site conditions
Fatigue	7 (14.3%)	3 (6.1%)	0	0	0	10 (20.4%)
Skin and subcutaneous tissue disorders
Alopecia	9 (18.4%)	0	0	0	0	9 (18.4%)
Infections and infestations
Urinary tract infection	5 (10.2%)	4 (8.2%)	0	0	0	9 (18.4%)
Musculoskeletal and connective tissue disorders
Back pain	5 (10.2%)	0	0	0	0	5 (10.2%)
Renal and urinary disorders
Albuminuria	6 (12.2%)	1 (2.0%)	0	0	0	7 (14.3%)
Nervous system disorders
Hypoesthesia	6 (12.2%)	0	0	0	0	6 (12.2%)
Investigations
Alanine aminotransferase increased*	21 (42.9%)	3 (6.1%)	1 (2.0%)	0	0	25 (51.0%)
Aspartate aminotransferase increased**	20 (40.8%)	5(10.2%)	0	0	0	25 (51.0%)
Gamma glutamyl transferase increased***	13 (26.5%)	3 (6.1%)	2 (4.1%)	0	0	18 (36.7%)
White blood cell count decreased^#	8 (16.3%)	9 (18.4%)	2 (4.1%)	0	0	19 (38.8%)
Neutrophil count decreased	7 (14.3%)	6 (12.2%)	2 (4.1%)	0	0	15 (30.6%)
Lymphocytopenia	2 (4.1%)	6 (12.2%)	1 (2.0%)	0	0	9 (18.4%)
Beta 2 microglobulin urine increased	8 (16.3%)	0	0	0	0	8 (16.3%)
Thrombocytopenia	8 (16.3%)	0	0	0	0	8 (16.3%)
Weight loss	6 (12.2%)	1 (2.0%)	0	0	0	7 (14.3%)
Bilirubin increased^##	6 (12.2%)	0	0	0	0	6 (12.2%)
Blood alkaline phosphatase increased	6 (12.2%)	0	0	0	0	6 (12.2%)
White blood cell urine positive	5 (10.2%)	0	0	0	0	5 (10.2%)
Lactate dehydrogenase increased	5 (10.2%)	0	0	0	0	5 (10.2%)
Anemia	3 (6.1%)	2 (4.1%)	0	0	0	5 (10.2%)

^aPatients had previously received hydroxyurea treatment and 61.2% of the patients received prior interferon therapy
^bIn this table representing TEAEs occurring in ≥ 10% of patients, ten grade 3 TEAEs occurred in eight patients. Among them, possibly treatment-related TEAEs occurred in five patients
^*Four patients (8.2%) had a prior history of grade 1 alanine aminotransferase increase
^**One patient (2.0%) had a prior history of grade 1 aspartate aminotransferase increase
^***Three patients (6.1%) had a prior history of grade 1 gamma glutamyl transferase increase
^#Two patients received G-CSF management of the blood count decrease during treatment
^##Two patients (4.1%) had a prior history of grade 1 bilirubin increase

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ISSN: 2162-3619

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