From the Guidelines
Inflammatory bowel disease (IBD) diagnosis and treatment should prioritize a step-up approach, starting with conventional immunosuppressive therapies such as azathioprine or methotrexate, and progressing to biologics like infliximab, adalimumab, or vedolizumab for insufficient response or intolerance, as recommended by the most recent guidelines 1.
Diagnosis of IBD
The diagnosis of IBD is generally made by assessment of symptoms, biochemical markers, and colonoscopy combined with radiology and histology 1. The different phenotypes of IBD share common clinical features but may have a heterogeneous presentation, which includes abdominal pain, vomiting, diarrhea, rectal bleeding, weight loss, and anemia. Extra-intestinal manifestations such as arthritis, skin disorders, and uveitis may also be present.
Treatment of IBD
IBD therapy is tailored, and the choice of the treatment regimen depends on several factors, including the type, distribution, and disease severity, as well as co-morbidity and patient preferences 1.
- Conventional immunosuppressive therapies include azathioprine, 6-mercaptopurine, methotrexate, and 6-thioguanine.
- Biologics such as anti-TNF (infliximab, adalimumab, golimumab), anti-integrin (vedolizumab), and interleukin 12/23 inhibitors (ustekinumab) are used in cases of insufficient response to immunosuppressive treatment or intolerance.
- Small molecule therapies like JAK inhibitors (tofacitinib) have also been approved for the treatment of UC, offering an oral administration option with little to no risk of immunogenicity 1.
Management and Monitoring
Regular monitoring through colonoscopies, blood tests, and stool samples is essential to track disease activity and medication effectiveness 1. Patients should maintain a balanced diet, avoiding trigger foods, staying hydrated, and taking prescribed supplements like vitamin B12, vitamin D, and iron if deficient.
- Lifestyle modifications and regular medical follow-ups can effectively manage symptoms and prevent complications like strictures, fistulas, or increased colorectal cancer risk.
- Surgery is still frequently required, although the number of cases performed seems to have decreased in recent years, likely due to the introduction of anti-TNF therapy and improved multidisciplinary IBD management 1.
Recent Guidelines and Recommendations
The most recent guidelines recommend a personalized approach to IBD treatment, taking into account the individual patient's disease severity, medical history, and preferences 1.
- The ECCO guidelines on therapeutics in Crohn's disease emphasize the importance of medical treatment in managing CD, including the use of mesalazine, locally active steroids, systemic steroids, thiopurines, methotrexate, and biologic therapies 1.
- The WSES-AAST guidelines for the management of IBD in the emergency setting highlight the need for prompt recognition and treatment of IBD complications, such as abscesses and fistulas, to prevent morbidity and mortality 1.
From the FDA Drug Label
HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Crohn’s Disease (CD) (1.5): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis (UC) (1. 6): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
The diagnosis of Inflammatory Bowel Disease (IBD) is not explicitly stated in the drug label. The treatment for IBD, specifically for Crohn's Disease (CD) and Ulcerative Colitis (UC), is adalimumab (HUMIRA).
- The recommended dosage for Crohn's Disease is:
- Adults: 160 mg on Day 1,80 mg on Day 15, and 40 mg every other week starting on Day 29.
- Pediatric Patients 6 Years of Age and Older: varies by weight.
- The recommended dosage for Ulcerative Colitis is:
- Adults: 160 mg on Day 1,80 mg on Day 15, and 40 mg every other week starting on Day 29.
- Pediatric Patients 5 Years of Age and Older: varies by weight. 2
From the Research
Diagnosis and Treatment of Inflammatory Bowel Disease (IBD)
- The diagnosis and treatment of IBD involve a step-by-step approach, with the goal of inducing and maintaining remission 3.
- Non-biological treatments, such as mesalamine and corticosteroids, remain valuable approaches in the therapeutic armamentarium of IBD 4.
- Biological treatments, such as infliximab and azathioprine, have become mainstays of treatment for IBD, and combination therapy with these agents may help optimize biologic pharmacokinetics and improve outcomes 5.
Treatment Options for IBD
- For steroid-refractory Crohn's disease, combined infliximab plus azathioprine or risankizumab may be preferred in first line, with ustekinumab or adalimumab as second-line options 6.
- For steroid-refractory ulcerative colitis, infliximab plus azathioprine or upadacitinib may be preferred in first line, with filgotinib, tofacitinib, or ustekinumab as second-line options 6.
- For steroid-dependent courses in both diseases, azathioprine or vedolizumab may be used in first line, with infliximab or Janus kinase inhibitors as second-line options 6.
Emerging Therapeutic Options
- New therapies are being developed to block the inflammatory process at the gastrointestinal level, with a focus on modifying signaling pathways and maintaining the integrity of the epithelial barrier 7.
- These emerging therapies may lead to more personalized treatments with higher success rates and fewer relapses, and may also focus on achieving macroscopic changes at the endoscopic level and microscopic changes by achieving mucosal healing 7.