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GASTROENTEROLOGY
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Biosimilars in Inflammatory Bowel Disease 2017: State of the Science, State of the Art, and State of the Finances
1. Expression system 2. Manufacturing process 3. Assessment of physiochemical properties 4. Functional activities 5. Receptor binding and immunochemical properties 6. Measurement of impurities 7. Stability under multiple stress conditions…
Noninfectious and Nonmalignant Complications of Anti-TNF Therapy
Acute infusion/injection reactions Delayed infusion/injection reactions Timing of onset Within first hours of dose 3–14 days Clinical presentation Mild: Fever, nausea, vomiting, wheal formation, pruritus, erythema Serum sickness-like syndrome:…
Concomitant Use of Immunosuppressive Therapy with Tumor Necrosis Factor (TNF) Antagonists in Inflammatory Bowel Disease
Crohn’s disease Ulcerative colitis SONIC [7] COMMIT [9] UC-SUCCESS [8] IFX IFX + AZA IFX IFX + MTX IFX IFX + AZA Clinical remission (%) 44 57 78 76…
Tumor Necrosis Factor-Alpha Inhibitors and Risks of Malignancy
Fig. 13.1 (a) Relative risk by decade, Crohn’s disease. (b) Relative risk by decade, ulcerative colitis Non-melanoma Skin Cancer In the USA, NMSC is the most commonly diagnosed malignancy. NMSC…
Anti-integrin Agents in IBD: Efficacy and Risk of Complications
Fig. 16.1 Mechanism of action of adhesion molecules in the intestinal endothelium and their blockage by anti-adhesion drugs Integrins involved in T-cell migration are leucocyte function-associated antigen 1 (LFA-1 or…
Use of Biologics in the Postoperative Management of Crohn’s Disease
Time post-resection 1 year Clinical 0–44% Endoscopic 0–84% Surgical 4–25% 5 years Clinical 32% Endoscopic 55–77% Surgical 4–25% 10 years Clinical 52% Endoscopic 74% Surgical 12–57% Adapted from Connelly et…
Therapeutic Drug Monitoring of Biologic Agents
Assay type Advantages Disadvantages Commercial example in United States ELIS A • Ease of administration • Generally low cost • False positives • Interference in measuring antibodies in the presence of…
Quality, Safety, and Practical Considerations of Using Biologic Therapies
Fig. 18.1 Practical strategies for improving safety of biologic therapies Choice of Biologic Agents There are eight FDA-approved biologic agents to treat IBD, generally indicated for patients with active disease…