The AAPS Journal, Vol. 17, No. 6, November 2015 ( # 2015) DOI: 10.1208/s12248-015-9813-x
Erratum Erratum to: Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars? Howard Lee1,2
Published online 12 August 2015
Erratum to: AAPS J DOI 10.1208/s12248-013-9534-y Minor errors were published in Table II. The corrected Table II appears below.
The online version of the original article can be found at doi:10.1208/ s12248-013-9534-y. 1
Clinical Trials Center, Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, 101 DaehakroJongno-gu Seoul, 110-744, South Korea. 2 To whom correspondence should be addressed. (e-mail: [email protected]) 1550-7416/15/0600-1520/0 # 2015 American Association of Pharmaceutical Scientists
1520
Is Extrapolation of the Safety and Efficacy Data
1521
Table II. Efficacy of Infliximab in the Approved Indications Response, % Indication
Study
Efficacy endpoint
Week
Infliximab
Placebo
Differencea
Crohn’s disease
Targan et al. (18)
Ulcerative colitis
ACCENT I (15) Present et al. (16) ACCENT II (17) UC I (38)
Clinical response Clinical response Clinical remission Fistula response Fistula response Clinical response Clinical response Clinical response Clinical response Clinical response ACR20 ACR50 ACR70 ACR20 ACR50 ACR70 ASAS20 ASAS40 ASAS70b ACR20 ACR50 ACR70 ACR20 ACR50 ACR70 PASI 75 PASI 75 PASI 75
4 12 30 6 54 8 30 54 8 30 54 54 54 54 54 54 24 24 24 16 16 16 24 24 24 10 10 10
81 41 42 68 46 69 52 45 65 47 42 21 10 62 46 33 61 47 28 66 46 29 54 41 27 80 76 88
16 12 21 26 23 37 30 20 29 26 17 8 2 54 32 21 19 12 4 10 0 0 16 4 2 3 2 6
65 29 21 42 23 32 22 25 36 21 25 13 8 8 14 12 42 35 24 56 46 29 38 37 25 77 74 82
UC II (38) Rheumatoid arthritis
ATTRACT (12)
ASPIRE (13)
Ankylosing spondylitis
ASSERT (39)
Psoriatic arthritis
IMPACT 1 (40)
IMPACT 2 (41)
Plaque psoriasis
EXPRESS (30) EXPRESS II (29) SPIRIT (42)
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 a Placebo-adjusted difference (i.e., infliximab - placebo) in percentage point b From the label of REMICADE® (infliximab) available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5345lbl.pdf (accessed on May 1, 2013)
Erratum Erratum to: Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars? Howard Lee1,2
Published online 12 August 2015
Erratum to: AAPS J DOI 10.1208/s12248-013-9534-y Minor errors were published in Table II. The corrected Table II appears below.
The online version of the original article can be found at doi:10.1208/ s12248-013-9534-y. 1
Clinical Trials Center, Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, 101 DaehakroJongno-gu Seoul, 110-744, South Korea. 2 To whom correspondence should be addressed. (e-mail: [email protected]) 1550-7416/15/0600-1520/0 # 2015 American Association of Pharmaceutical Scientists
1520
Is Extrapolation of the Safety and Efficacy Data
1521
Table II. Efficacy of Infliximab in the Approved Indications Response, % Indication
Study
Efficacy endpoint
Week
Infliximab
Placebo
Differencea
Crohn’s disease
Targan et al. (18)
Ulcerative colitis
ACCENT I (15) Present et al. (16) ACCENT II (17) UC I (38)
Clinical response Clinical response Clinical remission Fistula response Fistula response Clinical response Clinical response Clinical response Clinical response Clinical response ACR20 ACR50 ACR70 ACR20 ACR50 ACR70 ASAS20 ASAS40 ASAS70b ACR20 ACR50 ACR70 ACR20 ACR50 ACR70 PASI 75 PASI 75 PASI 75
4 12 30 6 54 8 30 54 8 30 54 54 54 54 54 54 24 24 24 16 16 16 24 24 24 10 10 10
81 41 42 68 46 69 52 45 65 47 42 21 10 62 46 33 61 47 28 66 46 29 54 41 27 80 76 88
16 12 21 26 23 37 30 20 29 26 17 8 2 54 32 21 19 12 4 10 0 0 16 4 2 3 2 6
65 29 21 42 23 32 22 25 36 21 25 13 8 8 14 12 42 35 24 56 46 29 38 37 25 77 74 82
UC II (38) Rheumatoid arthritis
ATTRACT (12)
ASPIRE (13)
Ankylosing spondylitis
ASSERT (39)
Psoriatic arthritis
IMPACT 1 (40)
IMPACT 2 (41)
Plaque psoriasis
EXPRESS (30) EXPRESS II (29) SPIRIT (42)
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 a Placebo-adjusted difference (i.e., infliximab - placebo) in percentage point b From the label of REMICADE® (infliximab) available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5345lbl.pdf (accessed on May 1, 2013)
