Table S1. Adverse events of study-drug–related
Study
Adverse events of study-drug–related
Vedolizumab
Placebo
Sands
et al.
2014
Serious adverse event(13/209), serious infection(2), Nasopharyngitis(9),
Headache(11), Nasopharyngitis(9), Upper respiratory tract infection(9),
Arthralgia(10), Nausea(12), Abdominal pain(9), Anemia(5), Fatigue(6), Crohn’s
disease exacerbation(6), Vomiting(9), Pyrexia(7), Dizziness(5), Aphthous
stomatitis(4), Urinary tract infection(6), Musculoskeletal pain(4), Any cancer(0),
death(0).
Serious adverse event(13/207), serious infection(0), Nasopharyngitis(9),
Headache(15/207), Nasopharyngitis(8), Upper respiratory tract infection(5),
Arthralgia(9), Nausea(5), Abdominal pain(6), Anemia(1), Fatigue(2), Crohn’s
disease exacerbation(21), Vomiting(5), Pyrexia(13), Dizziness(4), Aphthous
stomatitis(3), Urinary tract infection(0), Musculoskeletal pain(0), Any cancer(0),
death(0).
Feagan
et al.
2013
Serious adverse event(77/209), serious infection(12), Nasopharyngitis(80),
Headache(80/620), Nasopharyngitis(80), Upper respiratory tract infection(52),
Arthralgia(56), Nausea(38), Abdominal pain(35), Anemia(35), Fatigue(33),
Cough(36), Ulcerative colitis(97), Any cancer(1), death(1).
Serious adverse event(37/207), serious infection(8), Nasopharyngitis(26),
Headache(28/275), Nasopharyngitis(26), Upper respiratory tract infection(21),
Arthralgia(25), Nausea(19), Abdominal pain(10), Anemia(16), Fatigue(10),
Cough(13), Ulcerative colitis(58), Any cancer(3), death(0).
Sandborn
et al.
2013
Serious adverse event(199/814), serious infection(45),
Nasopharyngitis(100), Headache(97/814), Nasopharyngitis(100), Upper
respiratory tract infection(54), Arthralgia(110), Nausea(90), Abdominal pain(79),
Fatigue(53), Vomiting(49), Back pain(38), Pyrexia(103), Crohn’s disease
exacerbation (164), Any cancer(4), death(4).
Serious adverse event(46/301), serious infection(9), Nasopharyngitis(24),
Headache(47/301),Nasopharyngitis(24), Upper respiratory tract infection(17),
Arthralgia(40), Nausea(30), Abdominal pain(39), Fatigue(14), Vomiting(23), Back
pain(12), Pyrexia(40), Crohn’s disease exacerbation (65), Any cancer(1),
death(1).
Parikh
et al.
2012
Serious adverse event(2/37), Nasopharyngitis(7), Headache(7),
Nasopharyngitis(1), Upper respiratory tract infection(3), Pharyngolaryngeal
pain(2), Pyrexia(2), Colitis ulcerative(3), Cough(2), Hypertension(2), Influenza-like
illness(2), Constipation(1), Dizziness(1), Any cancer(0), death(0).
Serious adverse event(0/9), Nasopharyngitis(3), Headache(1),
Nasopharyngitis(3), Upper respiratory tract infection(3), Pharyngolaryngeal
pain(0), Pyrexia(0), Colitis ulcerative(4), Cough(0), Hypertension(0), Influenzalike illness(0), Constipation(1), Dizziness(1), Any cancer(0), death(0).
Feagan
et al.
2008
Serious adverse event(37/127), serious infection(1), Nasopharyngitis(19),
Headache(46), Nasopharyngitis(19), Pyrexia(14), Crohn’s disease aggravated(10),
Abdominal pain(19), Fatigue(23), Nausea(23), Any cancer(0), death(0).
Serious adverse event(19/58), serious infection(2), Nasopharyngitis(3),
Headache(14), Nasopharyngitis(3), Pyrexia(4), Crohn’s disease aggravated(5),
Abdominal pain(11), Fatigue(11), Nausea(7), Any cancer(0), death(0).
Feagan
et al.
2005
Serious adverse event(18/118), serious infection(1), Nasopharyngitis(19),
Headache(23), Nasopharyngitis(16), Arthralgia(11), Nausea(26), Abdominal
pain(11), Fatigue(13), Ulcerative colitis aggravated(51), Dizziness(10), Rash(10),
Vomiting(8), Blood in stool(9), Frequent bowel movements(15), Abdominal
tenderness(5), Any cancer(0), death(0).
Serious adverse event(6/63), serious infection(2), Nasopharyngitis(3),
Headache(13), Nasopharyngitis(5), Arthralgia(5), Nausea(10), Abdominal
pain(8), Fatigue(7), Ulcerative colitis aggravated(24), Dizziness(1), Rash(4),
Vomiting(5), Blood in stool(8), Frequent bowel movements(10), Abdominal
tenderness(8), Any cancer(0), death(0).
Table S2. Definitions of clinical response and clinical remission among included studies
Study, year
Diseases
Clinical/ CDAI-100 response
Clinical remission
Feagan et al.
2013
UC
Defined as a reduction in the Mayo Clinic score of at least 3 points and a decrease
of at least 30% from the baseline score, with a decrease of at least 1 point on the
rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1.
Defined as a Mayo Clinic score of 2 or lower
and no subscore higher than 1.
Parikh et al.
2012
UC
Defined as a PMS of ≤2 with no individual
subscore >1.
Feagan et al.
2005
UC
Defined as a decrease from baseline in the PMS of ≥2 points and ≥25%, with
an accompanying decrease in the subscore for rectal bleeding of≥1 point or an
absolute subscore for rectal bleeding of 0 or 1.
Defined as a reduction in the Mayo Clinic score of at least 3 points.
Sands et al.
2014
Sandborn et al.
2013
Feagan et al.
2008
CD
CDAI score≥100-point decrease in the CDAI score.
Defined as an ulcerative colitis clinical score
of 0 or 1 and a modified Baron score of 0 or
1 with no evidence of rectal bleeding.
CDAI score ≤150 points.
CD
CDAI score≥100-point decrease in the CDAI score.
CDAI score ≤150 points.
CD
CDAI score≥100-point decrease in the CDAI score.
CDAI score ≤150 points.
UC, Ulcerative colitis; CD, Crohn’s disease; PMS, partial Mayo score; CDAI, Crohn’s Disease Activity Index