Erratum to: Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars?

Erratum to: AAPS J

DOI 10.1208/s12248-013-9534-y

Minor errors were published in Table II. The corrected Table II appears below.

Table II.

Efficacy of Infliximab in the Approved Indications

Indication	Study	Efficacy endpoint	Week	Response, %
				Infliximab	Placebo	Differencea
Crohn’s disease	Targan et al. (18)	Clinical response	4	81	16	65
		Clinical response	12	41	12	29
	ACCENT I (15)	Clinical remission	30	42	21	21
	Present et al. (16)	Fistula response	6	68	26	42
	ACCENT II (17)	Fistula response	54	46	23	23
Ulcerative colitis	UC I (38)	Clinical response	8	69	37	32
		Clinical response	30	52	30	22
		Clinical response	54	45	20	25
	UC II (38)	Clinical response	8	65	29	36
		Clinical response	30	47	26	21
Rheumatoid arthritis	ATTRACT (12)	ACR20	54	42	17	25
		ACR50	54	21	8	13
		ACR70	54	10	2	8
	ASPIRE (13)	ACR20	54	62	54	8
		ACR50	54	46	32	14
		ACR70	54	33	21	12
Ankylosing spondylitis	ASSERT (39)	ASAS20	24	61	19	42
		ASAS40	24	47	12	35
		ASAS70b	24	28	4	24
Psoriatic arthritis	IMPACT 1 (40)	ACR20	16	66	10	56
		ACR50	16	46	0	46
		ACR70	16	29	0	29
	IMPACT 2 (41)	ACR20	24	54	16	38
		ACR50	24	41	4	37
		ACR70	24	27	2	25
Plaque psoriasis	EXPRESS (30)	PASI 75	10	80	3	77
	EXPRESS II (29)	PASI 75	10	76	2	74
	SPIRIT (42)	PASI 75	10	88	6	82

ACR20, ACR50, and ACR70 American College of Rheumatology 20, 50, and 70% response criteria, respectively; ASAS20, ASAS40, and ASAS70 Assessments in Ankylosing Spondylitis 20, 40, and 70% response criteria, respectively; PASI75 75% reduction in the Psoriasis Area and Severity Index score

^aPlacebo-adjusted difference (i.e., infliximab - placebo) in percentage point

^bFrom the label of REMICADE^® (infliximab) available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5345lbl.pdf (accessed on May 1, 2013)