Real-world data on therapy response to inflammatory bowel disease biological treatments in patients with concurrent primary sclerosing cholangitis: a case-control study

Introduction: Biological therapies have improved outcomes of patients diagnosed with Inflammatory Bowel Diseases (IBD) such as Ulcerative colitis (UC) and Crohn’s disease (CD). However, nonresponse or loss of response remains a significant challenge. Primary sclerosing cholangitis (PSC) is associated with IBDs, but the impact of concurrent PSC on response to IBD therapy is not well explored.

Aims: This study compared therapy response to IBD treatment with Infliximab (IFX), Vedolizumab (VDZ) and Ustekinumab (UST) in patients diagnosed with PSC and IBD (PSC/IBD group) versus patients diagnosed with IBD only (control group).

Methods: We identified 46 patients in the PSC/IBD group and 180 in the control group treated with IFX, VDZ and/or UST at our IBD outpatient clinic at Charité – Universitätsmedizin Berlin. Propensity score matching was employed to match the groups with a ratio of 1:1 based on age, sex, BMI, smoking status, Charlson Comorbidity Index (CCI), IBD subtype, duration of IBD, age at IBD diagnosis and Montreal-Classification (tolerance=0.2).

The primary outcome was clinical therapy response within 20 weeks, defined as remission (partial Mayo Score (pMS)≤1/Harvey-Bradshaw-Index (HBI)<5) or partial response (decrease of pMS≥2/HBI>3). Group differences were compared using Fisher´s Exact test ([Fig. 1] [2] [3]).

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Secondary outcomes included time to loss of response, mucosal healing (defined as no or mild inflammation e.g. Mayo Endoscopic Score 0 or 1) and decreased levels of C-reactive Protein (CRP)<5mg/l and faecal calprotectin (FC)<50mg/g. Only patients achieving clinical remission or partial response were included in the secondary analyses.

Results: After matching, 46 patients per group were analysed, with a total of 136 treatments administered ([Table 1]). While clinical response rates did not significantly differ between groups in patients receiving IFX or VDZ, in patients treated with UST clinical remission and partial response rates were significantly lower in the PSC/IBD group (p=0.04, [Table 2]). The time to loss of response was not different between groups across all therapies. Mucosal healing rates were lower in the PSC/IBD group compared to controls as well as decreased levels of CRP and FC ([Table 2]).

Table 1 Propensity Score matched cohort demographics and disease characteristics

Variables		PSC/IBD group (n=46)	Control group (n=46)	p-value (Chi-2/t-test)
Age (Mean±SD)		39.7±12.4	39.9±13.9	0.962
Sex – male (%)		31 (67.4%)	24 (52.2%)	0.137
BMI (Mean±SD)		23.1±3.9	23.8±4.8	0.443
Smoker – yes (%)		9 (20.0%)	13 (31.7%)	0.214
CCI (Mean±SD)		0.6±1.1	0.5±1.0	0.692
UC	N (%)	34 (73.9%)	34 (73.9%)	1.000
	Pancolitis (% from UC)	31 (93.9%)	26 (81.3%)	0.150
CD (%)		12 (26.1%)	12 (26.1%)	1.000
Patients treated with Infliximab		19	20
Patients treated with Vedolizumab		28	22
Patients treated with Ustekinumab		21	26

Table 2 Comparison of therapy response to IBD treatment with Infliximab, Vedolizumab and Ustekinumab between patients.

Variables	IFX-PSC (n=19)	IFX-control (n=20)	VDZ-PSC (n=28)	VDZ-control (n=22)	UST-PSC (n=21)	UST-control (n=26)
IBD-subtype UC (%)	11 (57.9%)	16 (80.0%)	24 (85.7%)	20 (90.9%)	14 (66.7%)	16 (61.5%)
Primary Outcome
clinical remission (%)	13 (68.4%)	14 (70.0%)	19 (67.9%)	18 (81.8%)	8 (38.1%)	18 (69.2%)
clinical partial response (%)	2 (10.5%)	1 (5.0%)	4 (14.3%)	1 (4.6%)	1 (4.8%)	2 (7.7%)
p-values (Fisher´s Exact test)	p=1.0		p=0.521		p=0.044
Secondary outcomes (only patients with clinical remission or partial response included)
Time to loss of response (M±SD)	13±11 months	16±9 months	25±18 months	32±21 months	13±4 months	12±9 months
Mucosal healing (%)	4 (50.0%)	7 (87.5%)	9 (45.0%)	11 (84.6%)	1 (20.0%)	9 (75.0%)
Decreased CRP and FC (%)	10 (76.9%)	13 (86.7%)	8 (47.1%)	16 (88.9%)	2 (40.0%)	14 (77.8%)

Conclusion: IFX and VDZ appear equally efficient for achieving clinical response in IBD patients with and without PSC, while the efficacy of UST is significantly lower in IBD patients with PSC. Future prospective data is needed to strengthen our knowledge of treatment outcomes in this population.

 

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Publication History

Article published online:
04 September 2025