331hepatotoxicity, 231
infliximab, 316
infusion/injection site reactions, 231
leukocyte trafficking inhibition, 114
lupus-like reaction, 231
mycobacterial infections
invasive fungal infections, 195
Pneumocystis jiroveci pneumonia,
195
tuberculosis, 194
natalizumab, 316
patient education, 315, 318
patient selection, 317
psoriasiform, 231
safety monitoring, 315, 316, 323
screening tests
anti-IL12/IL23, 321
anti-integrin therapies, 320
anti-TNF therapy, 319, 320
and baseline lab, 315
ustekinumab, 321
therapy costs, 316
treatment
patient selection, 324
safety monitoring, 322, 323
ustekinumab, 316
vaccination schedules, 315, 321, 322
vedolizumab, 316
viral infections
antiviral prophylaxis, 199
cytomegalovirus infection, 200
Epstein-Barr virus infection, 201
hepatitis B virus infection, 198
hepatitis C virus, 200
herpes simplex virus infection, 202
influenza infection, 198
serologic testing, 198
varicella zoster infection, 201
Biosimilars, 3, 266–270
clinical criteria
inflammatory bowel diseases, CT-P13,
268, 270
pharmacokinetic properties, 266
rheumatoidarthritis, CT-P13, 268
CT-P13
in ankylosing spondylitis, 267, 268
in inflammatory bowel diseases,
268–270
drug development, 262
economic considerations, 276, 277
extrapolation, 270–272
FDA guidance, 263
gastroenterological concerns, 276
immunogenicity, 262
interchangeability, 273–275
manufacturing process, 263, 264
market financials, 277
post-translational modification, 262
quality features, 263
synthetic process, 264
Bone metabolism, 54
Breastfeeding, 93, 94
anti-TNF agents
adalimumab, 94
certolizumab pegol, 94
infliximab, 93, 94C
Certolizumab pegol, 38–41
CD
clinical efficacy, 39–41
fistula healing, 41
mucosal healing, 41
Cervical cancer, 221, 222
Clinical assessment of adalimumab safety and
efficacy studied as induction
therapy in Crohn’s disease
(CLASSIC I) trial, 37
Clostridium difficile infection (CDI), 186
Colorectal cancer (CRC), 222
Complement-dependent cytotoxicity
(CDC), 3
Complete blood counts (CBC), 323
C-reactive protein (CRP), 62
Crohn’s disease (CD), 33, 60–71, 73, 169
in children (see Pediatric Crohn’s
disease)
postoperative recurrence
abdominal ultrasound, 62, 63
anastomotic technique, 65, 66
CRP, 62
disease behavior, 65
endoscopy, 60, 61, 70
fCal, 61
intra-observer reliability, 61
management algorithm, 73
patient-related factors, 63–65
prevention, 66–71
Rutgeerts scoring system, 60, 61
types, 60
transmural inflammatory process, 113
treatment, anti-TNF (see Anti-tumor
necrosis factor (anti-TNF) agents)
Crohn’s Disease Activity Index (CDAI), 34
Crohn’s Trial of the Fully Human Antibody
Adalimumab for Remission
Maintenance (CHARM) study, 37Index