Clinical outcomes and sick leave in relation to UDCA treatment in Swedish patients with primary biliary cholangitis

Figures & data

Table 1. Baseline characteristics for patients with PBC by treatment categories according to Paris-1 (n = 526).

	Untreated (n = 96)	Non-Responder (n = 56)	Responder (n = 350)	Response unknown* (n = 24)	p-value**
Age at diagnosis, years, median (IQR)	63.0 (53.5–74.5)	54.0 (43.5–66.5)	60.0 (51.0–68.0)	60.5 (49.0–68.0)	.003
Female, n (%)	83 (86.5%)	47 (83.9%)	304 (86.9%)	22 (91.7%)	.838
Cirrhosis at diagnosis, n (%)	18 (18.8%)	9 (16.1%)	30 (8.6%)	2 (8.3%)	<.001
Variables not included in Cox regression
ALP IU/L, median (IQR)***	192 (126–330)	582 (300–828)	228 (150–360)	282 (210–336)	<.001
Bilirubin µmol/L; median (IQR)	9.1 (6.2–15.0)	20.0 (10.0–28.0)	9.0 (7.0–13.0)	8.6 (6.0–17.0)	<.001
Globe score, high risk n (%)****	–	26 (53.1%)	17 (4.9%)	–	–
Positive AMA, n (%)*****	80 (83.3%)	52 (92.9%)	323 (92.3%)	23 (95.8%)	.779
Concurrent autoimmune disease, n (%)	40 (41.7%)	11 (19.6%)	114 (32.6%)	8 (33.3%)	.029
Fatigue, n (%)	17 (17.7%)	9 (16.1%)	70 (20.0%)	4 (16.7%)	.992
Pruritus, n (%)	14 (14.6%)	27 (48.2%)	68 (19.4%)	3 (12.5%)	<.001

*Responder status could not be evaluated due to missing laboratory data after one year on UDCA. **Kruskal-Wallis is used for continuous variables, Fisher´s exact test is used for categorical variables. ***ALP: ALP, alkaline phosphatase (IU/L), ****Globe score, large number of missing cases in untreated and response unknown *****AMA: antimitochondrial antibody.

Table 2. Cox regression for transplantation-free survival (n = 526).

	Unadjusted HR 95% CI	p	Adjusted HR 95%CI	P
Response according to Paris-1
Responder (n = 350) (ref)	1.00	–	1.00	–
Untreated (n = 96)	4.28 (2.43–7.55)	<.001	3.62 (2.02–6.49)	<.001
Non-responder (n = 56)	4.06 (2.03–8.10)	<.001	3.78 (1.87–7.66)	<.001
Response unknown* (n = 24)	3.64 (1.39–9.51)	.008	4.89 (1.85–12.94)	.001
Response according to Toronto
Responder (n = 317) (ref)	1.00	–	1.00	–
Untreated (n = 93)	3.75 (2.13–6.60)	<.001	3.08 (1.72–5.50)	<.001
Non-responder (n = 95)	1.68 (0.84–3.35)	.140	1.57 (0.78–3.18)	.210
Response unknown* (n = 20)	4.42 (1.69–11.56)	.002	5.43 (2.06–14.33)	.001

Cox regression for transplantation-free survival, adjusted for age at diagnosis, sex and cirrhosis at diagnosis. *Response unknown = Response to treatment according to Paris-1 or Toronto score could not be calculated due to missing laboratory data after one year of treatment with UDCA.

Table 3. Logistic regression for the association with sick leave ≥30 registered net days per year in patients with PBC.

	Sick leave during first year (n = 277) OR 95% CI	p	Sick leave during second year (n = 277) OR 95% CI	p
No UDCA treatment	2.28 (0.93–5.62)	.073	3.22 (1.12–9.25)	.030
Treatment (ref)	1.00	–	1.00	–
Age at diagnosis	1.00 (0.96–1.03)	.922	1.03 (0.98–1.07)	.227
Sex (male)	0.55 (0.19–1.57)	.264	0.12 (0.02–0.97)	.046
Sick leave before diagnosis
0 net days* (ref)	1.00	–	1.00	–
1–30 net days	2.44 (0.95–6.29)	.064	2.03 (0.68–6.08)	.206
>30 net days	11.92 (5.60–25.35)	<.001	8.31 (3.39–20.40)	<.001

The logistic regression model was adjusted for age at diagnosis, sex, UDCA treatment and sick leave one year before diagnosis. Only adjusted numbers shown. *One net day is one full-time calendar day with sick leave, e.g., two days with 50% part-time sick leave constitute one net day.

Table 4. Conditional logistic regression analysis on sick leave one year after diagnosis in patients with PBC compared to matched controls.

	PBC*/matched controls (n)	OR (95% CI)
All	165/1,642	2.50 (1.69–3.70)
Excluding untreated	145/1,438	2.28 (1.50–3.46
Excluding all but responder Paris-1**	116/1,153	2.18 (1.36–3.47)
Excluding all but non-responder P1***	20/191	2.19 (0.62–7.76)
Excluding cirrhosis	143/1,423	2.34 (1.54–3.55)
Excluding other AID****	111/1,078	2.16 (1.32–3.51)
Excluding pruritus	119/1,190	2.54 (1.59–4.06)
Excluding fatigue	90/895	3.30 (2.01–5.43)

*Patients with missing data on each comorbidity were excluded from respective analysis. **Responder-status one year after diagnosis, ***P1 short for Paris 1. ****AID, concurrent autoimmune diseases.