Add-on multiple submucosal injections of the RNA oligonucleotide GUT-1 to anti-TNF antibody treatment in patients with moderate-to-severe ulcerative colitis: an open-label, proof-of concept study

Table 2 Individual summary

Case	Age/Sex	DD	DD^a-TNF	CM	Modified Mayo Score					RS W6	RM W6	EI W6	Recurrence W52
						BL	W2	W4	W6
1	23F	1	0.6 IFX	ADA, AZP, PSL, 5-ASA	ES	2	2	1	0	✔	✔	✔	(-)
1	23F	1	0.6 IFX	ADA, AZP, PSL, 5-ASA	mMS	8	7	3	0	✔	✔	✔	(-)
2	51 M	12	6 IFX	ADA, TAC, 5-ASA	ES	2	1	1	1	✔		✔	W44 ( +)^b
2	51 M	12	6 IFX	ADA, TAC, 5-ASA	mMS	6	3	2	2	✔		✔	W44 ( +)^b
3	35 M	7	4 IFX	IFX, AZP, 5-ASA	ES	2	2	2	1	✔	✔	✔	(-)
3	35 M	7	4 IFX	IFX, AZP, 5-ASA	mMS	7	4	3	2	✔	✔	✔	(-)
4	32 M	4	4 IFX	IFX, PSL, 5-ASA	ES	3	2	1	1	✔	✔	✔	W36 ( +)^b
4	32 M	4	4 IFX	IFX, PSL, 5-ASA	mMS	9	7	3	2	✔	✔	✔	W36 ( +)^b
5	50 M	5	4 IFX	IFX, AZP, PSL, TAC, 5-ASA	ES	3	2	2	2	✔			(-)
5	50 M		4 IFX	IFX, AZP, PSL, TAC, 5-ASA	mMS	9	3	3	3	✔			(-)

DD Duration of disease (year), CM Concomitant medication, ADA Adalimumab, AZP Azathioprine, PSL prednisolone, ASA, IFX Infliximab, TAC Tacrolimus, ES Endoscopy Subscore, mMS Modified Mayo Score, BL Baseline, W Week, RS Clinical response, RM Clinical remission, EI Endoscopic Improvement. ✔ Achieved RS, RM, EI at week 6
^aDD-TNF: Duration of disease (year) that exposed to prior anti-TNF antibody (IFX) before this study. In Case 1 and case 2, IFX was changed to ADA because of no response to IFX in the history and received ADA at least for 3 months before screening
^bClinical recurrence was confirmed by rectal bleeding and endoscopic examination (Week 44 for case 2 and week 36 for case 4) before the end of observation (Week 52)

ISSN: 1880-8190