Table 2.

Summary of safety and efficacy of anti-cytokine therapies in randomized, controlled trials

Study	Drug name	Targeted cytokine	Indication	No. of patients	Follow-up	Clinical response (%)	Clinical remission (%)	SAE (%)
Mannon et al[49]	ABT-874	IL-12/23	CD	79	8 wk	69	38	10
Sandborn et al[56]	Ustekinumab	IL-12/23	CD	131	8 wk	49	19	4
Sands et al[57]	Apilimod mesylate	IL-12/23	CD	220	168 d	25.7	NA	NSb
Ito et al[64]	Tocilizumab	IL-6	CD	36	12 wk	80	20	13
Hommes et al[68]	Fontolizumab	IFN-γ	CD	133	28 d	38-44	19-31	4.5
Reinisch et al[69]	Fontolizumab	IFN-γ	CD	201	29 d	31-38	21	13.6
Van assche et al[79]	Daclizumab	IL-2	UC	159	8 wk	25-33	2-7	4.3-12.5
Schreiber et al[85]	rhuIL-10	IL-10	CD	320	29 d	NA	23.5	7
Schreiber et al[86]	rhuIL-10	IL-10	UC	94	28 d	NA1	NA1	7.5
Colombel et al[87]	Tenovil	IL-10	Postoperative CD	65	12 wk	46% of patients with endoscopic recurrence		9
Sands et al[95]	rhIL-11	IL11	CD	148	8 wk	31.54	36.74	NS2
Herrlinger et al[90]	rhIL-11	IL-11	CD	51	12 wk	193	43	8
Pena-Rossi et al[96]	IFN-β1a	IFN-β1a	UC	194	12 wk	NA	20-29.2	12.3
Tilg et al[97]	PEG-IFN-α	IFN-α	UC	60	12 wk	NA	40	15

¹No difference between placebo and rhuIL-10 treatment;

²More headache, edema and increased platelet count;

³Significantly inferior than prednisolone;

⁴Significantly superior than placebo at a dose of 15 microg/kg weekly. SAE: Severe adverse event; IL: Interleukin; IFN: Interferon; CD: Crohn’s disease; UC: Ulcerative colitis; NA: Not available; NS: Not significant.