Combination treatment of inflammatory bowel disease: Present status and future perspectives

Table 1 Results of clinical trials with dual biologic therapy in patients with active inflammatory bowel disease

Ref.	No. of patients/disease	Kind of DBT	Efficacy	Side-effects
Sands et al[14], 2007	79 (two arms: 52 and 27 respectively) CD	IFX + Natali-zumab vs IFX + placebo	Better results in DBT but not significant	Headache, infections (27%), nausea, nasopharyngitis
Privitera et al[11], 2020	16 (11 with CD & 5 with UC)	anti-TNF + VDZ or UST or VDZ & UST for 8 wk	Clinical improvement (intestinal and extraintestinal manifestations): In all patients	In 3 patients, all non-serious
Glassner et al[12], 2020	50 IBD patients (32 CD, 18 UC)	29 out of 50 patients received DBT	DBT: More patients in clinical and endoscopic remission at follow-up vs baseline	In 26% of pts. Infections: In patients on DBT. Lower risk in those not on a concomitant immunomodulator
Yang et al[15], 2020	22 patients with CD with 24 therapeutic trials of DBT	Six biologic agents were used in: Anti-TNF + UST or VDZ	Endoscopic improvement: In 43% of trials. Endoscopic remission: 26%. Clinical response: 50%. Clinical remission: 41%	Similar rates of adverse events (13% of trials)
Kwapisz et al[13], 2021	15 (14 CD, 1 UC)	Various biologics VDZ + anti-TNF/UST; UST + anti-TNF/VDZ	DBT may be effective. Anti-TNF or VDZ plus UST were most effective	DBT may be safe
Feagan et al[19], 2023	Severe UC	GUS + GOL (71) vs GUS alone (72) vs GOL alone (71 pts)	At week 12, 83% of DBT patients had clinical response vs 61% and 75% on GOL and GUS monotherapy, respectively	At week 50, 63%, 76% and 65% of patients experienced at least one side-effect (infections, fever, nasopharyngitis, neutropenia
Miyatani et al[18], 2024	CD	UPA + UST	5/6 patients, achi-evedremission. Two with severe arthritis: Signifi-cant improvement	Mild respiratory symptoms and nausea

CD: Crohn’s disease; GOL: Golimumab; GUS: Guselkumab, IBD: Inflammatory bowel disease; IFX: Infliximab; TNF: Tumor necrosis factor; UC: Ulcerative colitis; UST: Ustekinumab; UPA: Upadacitinib; VDZ: Vedolizumab; DBT: Dual biologic therapy.