. Author manuscript; available in PMC: 2020 Aug 1.

Published in final edited form as: Clin Gastroenterol Hepatol. 2019 Mar 27;17(9):1655–1668.e3. doi: 10.1016/j.cgh.2019.03.037

Table 3.

Association of anti-drug antibodies with therapeutic outcomes in inflammatory bowel disease.

Drug	IBD type		ADA	Therapeutic outcome	TDM assay	Assay type	Ref.
IFX	CD		≥282 ng/mL-eq	Lower success rate of treatment optimization	ELISA	Leuven drug-tolerant assay	75
IFX	CD		>8 μg/mL-eq	Shorter clinical response	ELISA	Prometheus	28
IFX	CD		Detectable	Lack of mucosal healing	ELISA	MP Biomedicals	17
IFX	CD		Detectable	Elevated CRP (>5 mg/L)	HMSA	Prometheus	56
IFX	CD		Detectable	Elevated CPP (>5 mg/L)	HMSA	Prometheus	60
IFX	CD		Detectable	Lack of fistula healing	HMSA	Prometheus	12
IFX	CD		Detectable	SLR	ELISA	Prometheus	88
IFX	CD		Detectable	SLR	RIA	Biomonitor A/S	87
IFX	UC		Detectable	Lack of endoscopic response	HMSA	Prometheus	33
IFX	UC		Detectable	Lack of mucosal healing	ELISA	Leuven drug-tolerant assay	67
IFX	CD/UC		≥8.8 U/ml	Drug discontinuation	HMSA	Prometheus	86
IFX	CD/UC		Detectable	PNR	ELISA	AHLC	73
IFX	CD/UC		Detectable	Drug discontinuation	HMSA	Prometheus	63
IFX	CD/UC		>9.1 U/ml	Failure of dose intensification after SLR	HMSA	Prometheus	63
IFX	CD/UC		>12 U/mL	Surgery	HMSA	Prometheus	85
IFX	CD/UC		Undetectable	Mucosal healing	ELISA	AHLC	13
IFX	CD/UC		Undetectable	Short-term clinical response	HMSA	Prometheus	27
IFX	CD/UC	Detectable		SLR	ELISA	AHLC	32
IFX	CD/UC	Detectable		SLR	ELISA	AHLC	84
IFX	CD/UC	>9 μg/mL-eq		When SLR, longer duration of response when anti-TNF agents are switched than when dosage is increased	ELISA	AHLC	10
IFX	CD/UC	≥3.3 U/mL		Lack of post-adjustment endoscopic remission	HMSA	Prometheus	37
IFX	CD/UC	Detectable		Treatment related adverse events	ELISA	Promonitor Menarini / ImmunDiagnostik	83
IFX	CD/UC	Detectable^a		PNR (w14)	ELISA	AHLC	73
IFX	CD/UC	>4.3 μg/mL-eq^b		PNR (w14)	ELISA	AHLC	73
IFX	CD/UC	>9.1 U/mL		IFX discontinuation	HMSA	Prometheus	82
IFX	CD/UC	>9.1 U/mL		Infusion reactions	HMSA	Prometheus	82
IFX	CD/UC	>200 ng/mL-eq		No response to treatment optimization	ELISA	Theradiag	81
ADM	CD	Detectable		PNR	ELISA	AHLC	23
ADM	CD	Detectable		Drug discontinuation	HMSA	Prometheus	29
ADM	CD	Detectable		Drug discontinuation	ELISA	In-house	57
ADM	CD	>12 U/mL		Lack of clinical response	RIA	Biomonitor A/S	58
ADM	CD	Detectable		Active disease	ELISA	AHLC	15
ADM	CD	Detectable		Higher CRP and ESR	ELISA	Sumitomo Bakelite Co., Ltd	16
ADM	CD	Detectable^d		No clinical remission (w52)	RIA	Sanquin	21
ADM	CD	Detectable (w12)		Higher needs for dose escalation less frequently sustained clinical benefit due to PNR or SLR	ELISA	R-Biopharm AG	31
ADM	CD/UC	Detectable		Drug discontinuation	RIA	Biomonitor A/S	80
ADM	CD/UC	>4 μg/mL-eq		When SLR, longer duration of response when anti-TNF agents are switched than when dosage is increased	ELISA	AHLC	10
ADM	CD/UC	Detectable		SLR	RIA	Biomonitor A/S	14

either week 2 or 6;

week 2;

Université François-Rabelais, Immuno-Pharmaco-Genetics of Therapeutic Antibodies, Tours, France;

week 26.

ADA: anti-drug antibody; IFX: infliximab; ADM: adalimumab; ELISA: enzyme-linked immunosorbent assay; CD: Crohn’s disease; UC: ulcerative colitis; CRP: C-reactive protein; RIA: Radio-immunoassay; eq: equivalent; SLR: secondary loss of response; U: units; HMSA: homogeneous mobility shift assay; ESR: erythrocyte sedimentation rate; AHLC: antihuman lambda chain antibody; TDM: therapeutic drug monitoring; TNF: tumor necrosis factor; w: week; PNR: primary non-response; Ref.: references.