A non-interventional, post-marketing surveillance study evaluating the safety and effectiveness of biosimilar rituximab (CT-P10) during routine clinical practice in the Republic of Korea

Figures & data

Figure 1. Study flow diagram.

*Multiple reasons for exclusion from the safety population were present for 8 patients. Five patients were excluded due to meeting exclusion criteria, loss to follow-up, and not receiving study drug. One patient was excluded due to not meeting inclusion criteria, not receiving study drug, receiving study drug prior to contract, and loss to follow-up. One patient was excluded due to meeting exclusion criteria and loss to follow-up. One patient was excluded due to not meeting inclusion criteria and receiving study drug prior to contract.CLL, chronic lymphocytic leukemia; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; GPA, granulomatosis with polyangiitis; MPA, microscopic polyangiitis; NHL, non-Hodgkin’s lymphoma; RA, rheumatoid arthritis.

Table 1. Patient demographics and baseline characteristics (safety population).

Characteristic	NHL (n = 604)*	CLL (n = 16)	RA (n = 42)	GPA/MPA (n = 15)^†
Age, median (range), years	62.0 (18.0–91.0)	62.0 (50.0–69.0)	57.5 (31.0–77.0)	59.0 (22.0–79.0)
Male, n (%)	356 (58.9)	13 (81.3)	2 (4.8)	6 (40.0)
Weight, mean (SD), kg	64.2 (12.9)	64.5 (9.7)	57.2 (9.8)	58.8 (11.5)
Prior rituximab use, n (%)	68 (11.3)	1 (6.3)	32 (76.2)	2 (13.3)
Disease duration, median (range), years	0.04 (0–24.0)	0.13 (0–6.0)	14.75 (1.4–30.0)	0.08 (0–4.0)
Ann Arbor stage,^‡ n (%) I II III IV	110 (18.2) 131 (21.7) 135 (22.4) 211 (34.9)
Rai stage,^‡ n (%) 0 I II III IV		2 (12.5) 1 (6.3) 3 (18.8) 3 (18.8) 6 (37.5)

*FL, n = 108 (17.88%) and DLBCL, n = 496 (82.12%).

^†GPA, n = 7 (46.67%) and MPA, n = 8 (53.33%).

^‡At baseline.CLL, chronic lymphocytic leukemia; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; GPA, granulomatosis with polyangiitis; MPA, microscopic polyangiitis; NHL, non-Hodgkin’s lymphoma; RA, rheumatoid arthritis; SD, standard deviation.

Table 2. Summary of safety, by indication (safety population).

Patients, n (%)	NHL/CLL (n = 620)	RA (n = 42)	GPA/MPA (n = 15)
Any AE	424 (68.4)	13 (31.0)	13 (86.7)
ADR*	172 (27.7)	6 (14.3)	2 (13.3)
Any serious AE	102 (16.5)	5 (11.9)	7 (46.7)
Serious ADR	31 (5.0)	3 (7.1)	1 (6.7)
Any unexpected AE	195 (31.5)	11 (26.2)	11 (73.3)
Unexpected ADR	29 (4.7)	4 (9.5)	1 (6.7)
Any AE leading to discontinuation of study drug	36 (5.8)	1 (2.4)	2 (13.3)
ADR leading to discontinuation of study drug	16 (2.6)	1 (2.4)	0
Death	14 (2.3)	0	2 (13.3)
Death due to ADR	5^† (0.8)	0	0

*Causal relationship to treatment with CT-P10 determined as ‘certain,’ ‘probable/likely,’ ‘possible,’ ‘conditional/unclassified,’ or ‘unassessable/unclassifiable.’

^†Three deaths classified as ‘unassessable/unclassifiable,’ and 2 deaths classified as ‘possible.’

ADR, adverse drug reaction; AE, adverse event; CLL, chronic lymphocytic leukemia; GPA, granulomatosis with polyangiitis; MPA, microscopic polyangiitis; NHL, non-Hodgkin’s lymphoma; RA, rheumatoid arthritis.

Table 3. Summary of serious ADRs by Preferred Term, by indication (safety population).

System Organ Class Preferred Term, n (%)	NHL/CLL (n = 620)
Any serious ADR	31 (5.0)
Infections and infestations
Pneumonia	7 (1.1)
Herpes zoster	3 (0.5)
Atypical pneumonia	1 (0.2)
Cytomegalovirus infection	1 (0.2)
Fungal pneumonia	1 (0.2)
Herpes simplex	1 (0.2)
Mycobacterial infection	1 (0.2)
Sepsis	1 (0.2)
Septic shock	1 (0.2)
Blood and lymphatic system disorders
Febrile neutropenia	5 (0.8)
Neutropenia	2 (0.3)
Pancytopenia	1 (0.2)
Thrombocytopenia	1 (0.2)
General disorders and administration site conditions
Death*^,†	3 (0.5)
Asthenia	1 (0.2)
Pyrexia	1 (0.2)
Respiratory, thoracic, and mediastinal disorders
Interstitial lung disease	1 (0.2)
Pneumonitis*	1 (0.2)
Respiratory arrest*	1 (0.2)
Cardiac disorders
Supraventricular tachycardia	1 (0.2)
Gastrointestinal disorders
Vomiting	1 (0.2)
Nervous system disorders
Dizziness	1 (0.2)
System Organ Class Preferred Term, n (%)	RA (n = 42)
Any serious ADR	3 (7.1)
Infections and infestations
Osteomyelitis*	1 (2.4)
Pneumocystis jirovecii pneumonia*	1 (2.4)
Pneumonia*	1 (2.4)
System Organ Class Preferred Term, n (%)	GPA/MPA (n = 15)
Any serious ADR	1 (6.7)
Infections and infestations
Atypical pneumonia	1 (6.7)

*Unexpected serious ADR.^†Event was unassessable/unclassifiable as cause of death was unknown.ADR, adverse drug reaction; CLL, chronic lymphocytic leukemia; GPA, granulomatosis with polyangiitis; MPA, microscopic polyangiitis; NHL, non-Hodgkin’s lymphoma; RA, rheumatoid arthritis.

Table 4. Summary of effectiveness, by indication (effectiveness population).

	n	Responders, n (%)	Non-responders, n (%)	Not evaluable, n (%)
NHL
Rituximab-naïve	484	468 (96.7)	16 (3.3)	0
Switched	65	33 (50.8)	3 (4.6)	29 (44.6)
FL
Rituximab-naïve	78	77 (98.7)	1 (1.3)	0
Switched	23	16 (69.6)	2 (8.7)	5 (21.7)
DLBCL
Rituximab-naïve	406	391 (96.3)	15 (3.7)	0
Switched	42	17 (40.5)	1 (2.4)	24 (57.1)
CLL
Rituximab-naïve	15	15 (100.0)	0	0
Switched	0	0	0	0
RA
Rituximab-naïve	9	7 (77.8)	1 (11.1)	1 (11.1)
Switched	23	23 (100.0)	0	0
GPA/MPA
Rituximab-naïve	13	5 (38.5)	8 (61.5)*	0
Switched	2	2 (100.0)	0	0

*No change in response for 4 (30.8%) patients, and deterioration in response for 4 (30.8%) patients.

CLL, chronic lymphocytic leukemia; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; GPA, granulomatosis with polyangiitis; MPA, microscopic polyangiitis; NHL, non-Hodgkin’s lymphoma; RA, rheumatoid arthritis.

Data availability statement

The data that support the findings of this study are available from the corresponding author, SG Cho, upon reasonable request.