Table 3.
Anti-TNF therapy in patients with pouchitis, case reports, case series and cohort studies with < 10 patientsa
| Author/ Year |
Design | n | Drug | Indication for therapy |
Outcome/ Follow-up |
Outcome measures |
Outcome |
|---|---|---|---|---|---|---|---|
| Ricart 199962 | Retrospective; single center |
7 | IFX (n=2) + AZA (n=4) or MTX (n=1), |
CD and IPAA with perianal or pouch vaginal fistula (n=5) or pre-pouch ileitis with granuloma on histology (n=2) |
Clin. Ass. | Complete response: 6/7 (86%). Partial response: 1/7 (14%). Fistulae: 4/5 (80%) closure of fistula. |
|
| Viscido 200365 | Prospective | 7 | IFX + AZA |
Antibiotic refractory pouchitis (4 months) + Fistulae |
Short term: 10 weeks Long term 11 months (range 7- 33 months) |
Clin.assess. PDAI |
Short term: Complete response: 6/7 (86%) Partial response: 1/7 Fistulae: 5/7 (71%) fistula closure. Long term: Clinical response 7/7 (100%). Short term: PDAI mean 12 (10–15) decrease to 5 (3–8) |
| Kooros 200459 | Case series single center |
4 | IFX + AZA (n=3) or steroids (n=1) |
Fistula (n=2), histogy granuloma n=1), perianal skin tag (n=1) |
ND | PCDAI PDAI |
All patients improved clinically and endoscopically. |
| Mohanty 200460# | Case series single center |
8 | IFX | Pouchitis | ND | Clin.assess. | Complete response: 7/8 (88%). Partial response 1/8 (12%). |
| Molnar 200861 | Case study | 1 | IFX | Antibiotic resistant pouchitis, pyoderma |
16 months |
Clin.assess. PDAI |
Clinical and endoscopic remission. |
| Yeats 201066 | Case study | 1 | IFX | Antibiotic and 6-MP refractory pouchitis |
36 months |
Clin.ass. Endoscopy |
Clinical and endoscopic remission. |
| Akitake 201056 | Case study | 1 | IFX | Pouchitis + enteritis | ND | Clin.assess. + endoscopy |
Remission. |
| Barreiros-de Acosta 201249 | Retrospective, Multi-center |
8b | ADA; 5 monothe rapy, 3 +AZA |
Chronic antibiotic refractory (4 weeks) pouchitis |
1 year | Clin.assess. and if available PDAI |
Week 8: Remission: 1/8 (13%). Response: 5/8 (63%). No response: 2/8 (25%). Week 52: Remission: 2/8 (25%). Response: 2/8 (25%). No response: 2/8 (50%). |
| Viazis 201164 | Prospective cohort, single center |
7 | IFX | Chronic antibiotic refractory (4 weeks); n=4; fistula (n=3) |
1 year | PDAI + Clin.assess. |
Complete response: 5/7 (71%). Partial response: 1/7 (14%). No response: 1/7 (14%). Fistula closure: 2/3 (67%). |
| Viazis 201363 | Prospective cohort, single center |
7c | IFX | Chronic antibiotic refractory (4 weeks); n=4; fistula (n=3) |
3 years | Clin.assess. | 6/7 (86%) ongoing complete response. |
| Alvarez 201457# | Case study | 1 | ADA | Collagenous pouchitis |
ND | Clin.assess. | Improvement and resolution of collagen layer |
| Iizuka 201458 | Case study | 1 | IFX | Chronic antibiotic refractory+ fistula |
12 months |
Clin.assess. PDAI |
Remission, recurrence of symptoms while off IFX, then again remission after restart IFX |
Only English language articles were included in this systematic review. A Danish language case series of 3 patients with pouchitis and fistulizing complications treated with IFX was published in 200870
All patients had been previously treated with IFX; in five cases IFX was discontinued due to adverse events, in three cases because of a loss of response.
Same patients as in Viazis 2011 but longer follow-up
meeting abstract
Clin.assess.; Clinical assessment: no predefined score was utilized. Success or partial success are derived from patient reported outcomes (e.g improvement of abdominal pain, bleeding and diarrhea frequency, reduction of fistula drainage) and physician assessments (e.g fistula closure);PDAI; pouch disease activity index68;PCDAI; pediatric Crohn’s activity index.71