Comparative short-term response and remission rates for tacrolimus, cyclosporine, and infliximab for steroid-refractory ulcerative colitis
Details
Serval ID
serval:BIB_8A42FCDC8986
Type
Inproceedings: an article in a conference proceedings.
Publication sub-type
Abstract (Abstract): shot summary in a article that contain essentials elements presented during a scientific conference, lecture or from a poster.
Collection
Publications
Institution
Title
Comparative short-term response and remission rates for tacrolimus, cyclosporine, and infliximab for steroid-refractory ulcerative colitis
Title of the conference
DDW 2012, Digestive Disease Week
Address
San Diego, California, United-States, May 20-22, 2012
ISBN
0016-5085
ISSN-L
0021-9355
Publication state
Published
Issued date
2012
Volume
142
Series
Gastroenterology
Pages
S358
Language
english
Abstract
BACKGROUND: Calcineurin inhibitors (cyclosporine (CsA) and tacrolimus (Tcl)) and the
anti-TNF-antibody infliximab (IFX) are established therapeutic options in steroid-refractory
ulcerative colitis (UC). In acute severe UC failing steroids, a randomized trial showed an
85% short term response to CsA or IFX, with avoidance of colectomy. Comparative responses
to the three drugs in outpatients with steroid-refractory UC are unknown. METHOD:
Response to treatment in patients with steroid-refractory moderate to severe UC was retrospectively
studied in three cohorts of patients: Cohort A (n=24) treated with oral Tcl (initially
0.05mg/kg twice daily, aiming for serum trough levels of 5-10 ng/mL); Cohort B (n=19)
treated with intravenous CsA 2mg/kg/daily and then oral CsA 5mg/kg/daily; Cohort C. (n=
41) treated with IFX (5mg/kg intravenously at week 0, 2, 6 and then every 8 weeks). After
successful rescue therapy with Tcl or CsA, thiopurine maintenance therapy was introduced.
The endpoint was evaluation of clinical remission or response at week 6, on the basis of
modified Truelove-Witts severity index (MTWSI). RESULTS: After 6 weeks, 42% (10/24)
of patients treated with Tcl achieved remission (MTWSI score ≤4) compared to 47% (9/
19) on CsA and 66% (27/41) of patients treated with IFX (Tcl & CsA vs IFX p=0.127).
Clinical response (decrease of MTWSI score of more than 4 points) at week 6 was reached
in 25% (6/24) patients on Tcl, compared to 11% (2/19) on CsA and 20% (8/41) given IFX
(p=0.484). Subgroup analysis showed the highest rates of remission in those with moderate
steroid-refractory UC treated with IFX: 29% (2/7) in Tcl group compared to 50% (2/4) in
CsA group and 76 % (19/25) in IFX group (Tcl & CsA vs IFX p= 0.058) Patients with severe
colitis showed similar rates of remission in all three groups: 47% (8/17) on Tcl, 47% (7/
15) on CsA and 50% (8/16) on IFX (p= 0.700). Colectomy within 6 weeks occurred in 4%
(1/24) after Tcl, 5% (1/19) after CsA and 0% (0/41) after IFX. Adverse effects in the first
6 weeks were observed in 13% (3/24) on Tcl, 26% (5/19) on CsA, and 10% (4/41) on IFX
(p=0.224) CONCLUSION: No significant differences in response, remission, colectomy rate
or adverse events between the three agents were found, although the study is too small for
definitive conclusions. There are intriguing differences, with potentially greater response to
IFX in moderate, steroid-refractory UC.
anti-TNF-antibody infliximab (IFX) are established therapeutic options in steroid-refractory
ulcerative colitis (UC). In acute severe UC failing steroids, a randomized trial showed an
85% short term response to CsA or IFX, with avoidance of colectomy. Comparative responses
to the three drugs in outpatients with steroid-refractory UC are unknown. METHOD:
Response to treatment in patients with steroid-refractory moderate to severe UC was retrospectively
studied in three cohorts of patients: Cohort A (n=24) treated with oral Tcl (initially
0.05mg/kg twice daily, aiming for serum trough levels of 5-10 ng/mL); Cohort B (n=19)
treated with intravenous CsA 2mg/kg/daily and then oral CsA 5mg/kg/daily; Cohort C. (n=
41) treated with IFX (5mg/kg intravenously at week 0, 2, 6 and then every 8 weeks). After
successful rescue therapy with Tcl or CsA, thiopurine maintenance therapy was introduced.
The endpoint was evaluation of clinical remission or response at week 6, on the basis of
modified Truelove-Witts severity index (MTWSI). RESULTS: After 6 weeks, 42% (10/24)
of patients treated with Tcl achieved remission (MTWSI score ≤4) compared to 47% (9/
19) on CsA and 66% (27/41) of patients treated with IFX (Tcl & CsA vs IFX p=0.127).
Clinical response (decrease of MTWSI score of more than 4 points) at week 6 was reached
in 25% (6/24) patients on Tcl, compared to 11% (2/19) on CsA and 20% (8/41) given IFX
(p=0.484). Subgroup analysis showed the highest rates of remission in those with moderate
steroid-refractory UC treated with IFX: 29% (2/7) in Tcl group compared to 50% (2/4) in
CsA group and 76 % (19/25) in IFX group (Tcl & CsA vs IFX p= 0.058) Patients with severe
colitis showed similar rates of remission in all three groups: 47% (8/17) on Tcl, 47% (7/
15) on CsA and 50% (8/16) on IFX (p= 0.700). Colectomy within 6 weeks occurred in 4%
(1/24) after Tcl, 5% (1/19) after CsA and 0% (0/41) after IFX. Adverse effects in the first
6 weeks were observed in 13% (3/24) on Tcl, 26% (5/19) on CsA, and 10% (4/41) on IFX
(p=0.224) CONCLUSION: No significant differences in response, remission, colectomy rate
or adverse events between the three agents were found, although the study is too small for
definitive conclusions. There are intriguing differences, with potentially greater response to
IFX in moderate, steroid-refractory UC.
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