Table 2. Open in new tab Background...

		Post-ADR status
		Number and proportion (%) of patients
Demographics
Sex
Male	56	25	23%	31	21%
Female	203	85	77%	118	79%
Age (years)
<65	118	59	54%	59	40%
≥65	141	51	46%	90	60%
Mean ± SD	64.7 ± 11.5	62.3 ± 11.1	66.4 ± 11.6
Weight (kg)
<40	14	4	4%	10	7%
≥40	144	57	52%	87	58%
Not recorded	101	49	45%	52	35%
History of surgery for rheumatoid arthritis
No	208	89	81%	119	80%
Yes	44	15	14%	29	19%
Unknown	7	6	5%	1	1%
Duration of rheumatoid arthritis
<5 years	101	44	40%	57	38%
5 –<10 years	57	26	24%	31	21%
≥10 years	85	33	30%	52	35%
Unknown	16	7	6%	9	6%
Mean ± SD	9.59 ± 9.91	9.44 ± 9.98	9.70 ± 9.89
Steinbrocker stage classification
Stage I	51	19	17%	32	21%
Stage II	81	40	36%	41	28%
Stage III	52	23	21%	29	19%
Stage IV	72	26	24%	46	31%
Unknown	3	2	2%	1	1%
Steinbrocker functional classification
Class I	56	24	22%	32	21%
Class II	160	69	63%	91	61%
Class III	38	15	14%	23	15%
Class IV	4	1	1%	3	2%
Unknown	1	1	1%	0	0%
Allergy history
No	202	89	81%	113	76%
Yes	57	21	19%	36	24%
Comorbidities
Comorbidities
No	49	23	21%	26	17%
Yes	210	87	79%	123	83%
Liver dysfunction at baseline
No	230	98	89%	132	89%
Yes	29	12	11%	17	11%
Kidney dysfunction at baseline
No	245	103	94%	142	95%
Yes	14	7	6%	7	5%
Drug treatment
Prior MTX treatment
No	129	49	45%	80	54%
Yes	130	61	55%	69	46%
Concomitant drugs
No	2	0	0%	2	1%
Yes	257	110	100%	147	99%
Concomitant MTX
No	136	46	42%	90	60%
Yes	123	64	58%	59	40%
≤8 mg	67	31	28%	36	24%
>8 mg	56	33	30%	23	15%
Concomitant biologics
No	234	101	92%	133	89%
Yes	25	9	8%	16	11%
Concomitant steroids (maximum dose/PSL conversion) (oral drugs only)
No	123	55	50%	68	46%
Yes	136	55	50%	81	54%
≤5 mg	97	37	34%	60	40%
>5 mg	37	18	16%	19	13%
Not recorded	2	0	0%	2	1%
Concomitant NSAID
No	81	33	30%	48	32%
Yes	178	77	70%	101	68%
Concomitant folic acid
No	172	60	55%	112	75%
Yes	87	50	45%	37	25%

Post-ADR status

All patients (N =259)

Continuation (n = 110)

Discontinuation (n = 149)

Number and proportion (%) of patients

Demographics

Sex

Male

23%

21%

Female

203

77%

118

79%

Age (years)

<65

118

54%

40%

≥65

141

46%

60%

Mean ± SD

64.7 ± 11.5

62.3 ± 11.1

66.4 ± 11.6

Weight (kg)

<40

≥40

144

52%

58%

Not recorded

101

45%

35%

History of surgery for rheumatoid arthritis

208

81%

119

80%

Yes

14%

19%

Unknown

Duration of rheumatoid arthritis

<5 years

101

40%

38%

5 –<10 years

24%

21%

≥10 years

30%

35%

Unknown

Mean ± SD

9.59 ± 9.91

9.44 ± 9.98

9.70 ± 9.89

Steinbrocker stage classification

Stage I

17%

21%

Stage II

36%

28%

Stage III

21%

19%

Stage IV

24%

31%

Unknown

Steinbrocker functional classification

Class I

22%

21%

Class II

160

63%

61%

Class III

14%

15%

Class IV

Unknown

Allergy history

202

81%

113

76%

Yes

19%

24%

Comorbidities

21%

17%

Yes

210

79%

123

83%

Liver dysfunction at baseline

230

89%

132

89%

Yes

11%

Kidney dysfunction at baseline

245

103

94%

142

95%

Yes

Drug treatment

Prior MTX treatment

129

45%

54%

Yes

130

55%

46%

Concomitant drugs

Yes

257

110

100%

147

99%

Concomitant MTX

136

42%

60%

Yes

123

58%

40%

≤8 mg

28%

24%

>8 mg

30%

15%

Concomitant biologics

234

101

92%

133

89%

Yes

11%

Concomitant steroids (maximum dose/PSL conversion) (oral drugs only)

123

50%

46%

Yes

136

50%

54%

≤5 mg

34%

40%

>5 mg

16%

13%

Not recorded

Concomitant NSAID

30%

32%

Yes

178

70%

101

68%

Concomitant folic acid

172

55%

112

75%

Yes

45%

25%

		Post-ADR status
		Number and proportion (%) of patients
Demographics
Sex
Male	56	25	23%	31	21%
Female	203	85	77%	118	79%
Age (years)
<65	118	59	54%	59	40%
≥65	141	51	46%	90	60%
Mean ± SD	64.7 ± 11.5	62.3 ± 11.1	66.4 ± 11.6
Weight (kg)
<40	14	4	4%	10	7%
≥40	144	57	52%	87	58%
Not recorded	101	49	45%	52	35%
History of surgery for rheumatoid arthritis
No	208	89	81%	119	80%
Yes	44	15	14%	29	19%
Unknown	7	6	5%	1	1%
Duration of rheumatoid arthritis
<5 years	101	44	40%	57	38%
5 –<10 years	57	26	24%	31	21%
≥10 years	85	33	30%	52	35%
Unknown	16	7	6%	9	6%
Mean ± SD	9.59 ± 9.91	9.44 ± 9.98	9.70 ± 9.89
Steinbrocker stage classification
Stage I	51	19	17%	32	21%
Stage II	81	40	36%	41	28%
Stage III	52	23	21%	29	19%
Stage IV	72	26	24%	46	31%
Unknown	3	2	2%	1	1%
Steinbrocker functional classification
Class I	56	24	22%	32	21%
Class II	160	69	63%	91	61%
Class III	38	15	14%	23	15%
Class IV	4	1	1%	3	2%
Unknown	1	1	1%	0	0%
Allergy history
No	202	89	81%	113	76%
Yes	57	21	19%	36	24%
Comorbidities
Comorbidities
No	49	23	21%	26	17%
Yes	210	87	79%	123	83%
Liver dysfunction at baseline
No	230	98	89%	132	89%
Yes	29	12	11%	17	11%
Kidney dysfunction at baseline
No	245	103	94%	142	95%
Yes	14	7	6%	7	5%
Drug treatment
Prior MTX treatment
No	129	49	45%	80	54%
Yes	130	61	55%	69	46%
Concomitant drugs
No	2	0	0%	2	1%
Yes	257	110	100%	147	99%
Concomitant MTX
No	136	46	42%	90	60%
Yes	123	64	58%	59	40%
≤8 mg	67	31	28%	36	24%
>8 mg	56	33	30%	23	15%
Concomitant biologics
No	234	101	92%	133	89%
Yes	25	9	8%	16	11%
Concomitant steroids (maximum dose/PSL conversion) (oral drugs only)
No	123	55	50%	68	46%
Yes	136	55	50%	81	54%
≤5 mg	97	37	34%	60	40%
>5 mg	37	18	16%	19	13%
Not recorded	2	0	0%	2	1%
Concomitant NSAID
No	81	33	30%	48	32%
Yes	178	77	70%	101	68%
Concomitant folic acid
No	172	60	55%	112	75%
Yes	87	50	45%	37	25%

Table 2.

Open in new tab

Background characteristics of patients with liver dysfunction ADRs.

		Post-ADR status
	All patients (N =259)	Continuation (n = 110)	Discontinuation (n = 149)
		Number and proportion (%) of patients
Demographics
Sex
Male	56	25	23%	31	21%
Female	203	85	77%	118	79%
Age (years)
<65	118	59	54%	59	40%
≥65	141	51	46%	90	60%
Mean ± SD	64.7 ± 11.5	62.3 ± 11.1	66.4 ± 11.6
Weight (kg)
<40	14	4	4%	10	7%
≥40	144	57	52%	87	58%
Not recorded	101	49	45%	52	35%
History of surgery for rheumatoid arthritis
No	208	89	81%	119	80%
Yes	44	15	14%	29	19%
Unknown	7	6	5%	1	1%
Duration of rheumatoid arthritis
<5 years	101	44	40%	57	38%
5 –<10 years	57	26	24%	31	21%
≥10 years	85	33	30%	52	35%
Unknown	16	7	6%	9	6%
Mean ± SD	9.59 ± 9.91	9.44 ± 9.98	9.70 ± 9.89
Steinbrocker stage classification
Stage I	51	19	17%	32	21%
Stage II	81	40	36%	41	28%
Stage III	52	23	21%	29	19%
Stage IV	72	26	24%	46	31%
Unknown	3	2	2%	1	1%
Steinbrocker functional classification
Class I	56	24	22%	32	21%
Class II	160	69	63%	91	61%
Class III	38	15	14%	23	15%
Class IV	4	1	1%	3	2%
Unknown	1	1	1%	0	0%
Allergy history
No	202	89	81%	113	76%
Yes	57	21	19%	36	24%
Comorbidities
Comorbidities
No	49	23	21%	26	17%
Yes	210	87	79%	123	83%
Liver dysfunction at baseline
No	230	98	89%	132	89%
Yes	29	12	11%	17	11%
Kidney dysfunction at baseline
No	245	103	94%	142	95%
Yes	14	7	6%	7	5%
Drug treatment
Prior MTX treatment
No	129	49	45%	80	54%
Yes	130	61	55%	69	46%
Concomitant drugs
No	2	0	0%	2	1%
Yes	257	110	100%	147	99%
Concomitant MTX
No	136	46	42%	90	60%
Yes	123	64	58%	59	40%
≤8 mg	67	31	28%	36	24%
>8 mg	56	33	30%	23	15%
Concomitant biologics
No	234	101	92%	133	89%
Yes	25	9	8%	16	11%
Concomitant steroids (maximum dose/PSL conversion) (oral drugs only)
No	123	55	50%	68	46%
Yes	136	55	50%	81	54%
≤5 mg	97	37	34%	60	40%
>5 mg	37	18	16%	19	13%
Not recorded	2	0	0%	2	1%
Concomitant NSAID
No	81	33	30%	48	32%
Yes	178	77	70%	101	68%
Concomitant folic acid
No	172	60	55%	112	75%
Yes	87	50	45%	37	25%

		Post-ADR status
	All patients (N =259)	Continuation (n = 110)	Discontinuation (n = 149)
		Number and proportion (%) of patients
Demographics
Sex
Male	56	25	23%	31	21%
Female	203	85	77%	118	79%
Age (years)
<65	118	59	54%	59	40%
≥65	141	51	46%	90	60%
Mean ± SD	64.7 ± 11.5	62.3 ± 11.1	66.4 ± 11.6
Weight (kg)
<40	14	4	4%	10	7%
≥40	144	57	52%	87	58%
Not recorded	101	49	45%	52	35%
History of surgery for rheumatoid arthritis
No	208	89	81%	119	80%
Yes	44	15	14%	29	19%
Unknown	7	6	5%	1	1%
Duration of rheumatoid arthritis
<5 years	101	44	40%	57	38%
5 –<10 years	57	26	24%	31	21%
≥10 years	85	33	30%	52	35%
Unknown	16	7	6%	9	6%
Mean ± SD	9.59 ± 9.91	9.44 ± 9.98	9.70 ± 9.89
Steinbrocker stage classification
Stage I	51	19	17%	32	21%
Stage II	81	40	36%	41	28%
Stage III	52	23	21%	29	19%
Stage IV	72	26	24%	46	31%
Unknown	3	2	2%	1	1%
Steinbrocker functional classification
Class I	56	24	22%	32	21%
Class II	160	69	63%	91	61%
Class III	38	15	14%	23	15%
Class IV	4	1	1%	3	2%
Unknown	1	1	1%	0	0%
Allergy history
No	202	89	81%	113	76%
Yes	57	21	19%	36	24%
Comorbidities
Comorbidities
No	49	23	21%	26	17%
Yes	210	87	79%	123	83%
Liver dysfunction at baseline
No	230	98	89%	132	89%
Yes	29	12	11%	17	11%
Kidney dysfunction at baseline
No	245	103	94%	142	95%
Yes	14	7	6%	7	5%
Drug treatment
Prior MTX treatment
No	129	49	45%	80	54%
Yes	130	61	55%	69	46%
Concomitant drugs
No	2	0	0%	2	1%
Yes	257	110	100%	147	99%
Concomitant MTX
No	136	46	42%	90	60%
Yes	123	64	58%	59	40%
≤8 mg	67	31	28%	36	24%
>8 mg	56	33	30%	23	15%
Concomitant biologics
No	234	101	92%	133	89%
Yes	25	9	8%	16	11%
Concomitant steroids (maximum dose/PSL conversion) (oral drugs only)
No	123	55	50%	68	46%
Yes	136	55	50%	81	54%
≤5 mg	97	37	34%	60	40%
>5 mg	37	18	16%	19	13%
Not recorded	2	0	0%	2	1%
Concomitant NSAID
No	81	33	30%	48	32%
Yes	178	77	70%	101	68%
Concomitant folic acid
No	172	60	55%	112	75%
Yes	87	50	45%	37	25%

Background characteristics of patients who developed liver dysfunction. The composition ratio shows the percentage of continuations and discontinuations relative to all patients.

ADR: adverse drug reaction; MTX: methotrexate; PSL: prednisolone; NSAID: non-steroidal anti-inflammatory drug.

This Feature Is Available To Subscribers Only