What monitoring and physical exams are recommended for a 50-year-old male with Crohn's disease (CD) in remission, taking Humira (adalimumab) weekly for 8 years, with hypertension (HTN), benign prostatic hyperplasia (BPH), chronic prostatitis, chronic pelvic pain, and health anxiety?

From the Guidelines

A 50-year-old male with Crohn's disease in remission on long-term Humira therapy should undergo comprehensive monitoring including complete blood counts, liver function tests, and renal function tests every 3-6 months, as recommended by the most recent guidelines 1. Annual skin examinations are essential due to increased skin cancer risk with TNF inhibitors like Humira. Regular blood pressure monitoring is needed for his hypertension, with target readings below 130/80 mmHg. For his BPH and prostatitis, annual digital rectal examinations and PSA testing are recommended, with urological evaluation if symptoms worsen, using the AUA Symptom Index for symptom assessment 1. Tuberculosis screening should be performed annually with either a tuberculin skin test or interferon-gamma release assay due to the increased TB risk with Humira. Periodic stool calprotectin measurements can help monitor Crohn's disease activity, even during apparent remission, and intestinal ultrasound can be used as a noninvasive tool for assessing and monitoring IBD activity 1. Bone density scanning every 2-3 years is advisable due to increased osteoporosis risk in inflammatory bowel disease patients. Given his health anxiety, incorporating mental health screening during regular visits can help address psychological aspects of his chronic conditions. Vaccination status should be reviewed annually, ensuring he receives inactivated vaccines as needed, while avoiding live vaccines while on Humira.

Some key points to consider:

• The patient's Crohn's disease activity should be monitored using a combination of symptoms, objective measures of inflammation, and factors that predict an increased risk of complications 1.
• The use of anti-TNF biologics, such as Humira, is recommended for patients with moderate to severe luminal Crohn's disease with risk factors of poor prognosis 1.
• Intestinal ultrasound can be used to guide treatment adjustments and clinical decision-making in patients with IBD 1.
• The patient's BPH and prostatitis symptoms should be assessed using the AUA Symptom Index, and urological evaluation should be performed if symptoms worsen 1.

Overall, a comprehensive monitoring plan should be implemented to ensure the patient's Crohn's disease, hypertension, BPH, prostatitis, and health anxiety are well-managed, and to minimize the risk of complications and morbidity.

From the FDA Drug Label

WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS (5.1,6. 1): • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. • Discontinue Adalimumab-fkjp if a patient develops a serious infection or sepsis during treatment • Perform test for latent TB; if positive, start treatment for TB prior to starting Adalimumab-fkjp. • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY (5. 2): • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. • Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

The patient should be monitored for:

• Serious infections, including tuberculosis (TB), bacterial sepsis, and invasive fungal infections
• Malignancy, including lymphoma and hepatosplenic T-cell lymphoma (HSTCL)
• Active TB during treatment, even if initial latent TB test is negative Recommended physical exams and monitoring include:
• Regular TB testing
• Complete blood counts to monitor for signs of infection or malignancy
• Liver function tests to monitor for signs of hepatotoxicity
• Physical exam to monitor for signs of infection or malignancy 2 2

From the Research

Monitoring and Physical Exams for a 50-year-old Male with Crohn's Disease and Other Conditions

The patient has a complex medical history, including Crohn's disease in remission, hypertension, benign prostatic hyperplasia (BPH), chronic prostatitis, chronic pelvic pain, and health anxiety, and has been taking Humira (adalimumab) weekly for 8 years.

• Crohn's Disease Monitoring:
  • Regular blood tests to monitor adalimumab levels, as higher levels are associated with biologic remission 3
  • C-reactive protein (CRP) and fecal calprotectin tests to assess gut inflammation and biologic remission 3
  • Clinical activity assessment using the Harvey-Bradshaw Index 3
• Hypertension Monitoring:
  • Regular blood pressure checks to monitor hypertension
• BPH Monitoring:
  • Regular check-ups with a urologist to monitor BPH symptoms and prostate size
  • Consideration of 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) to reduce prostate volume and improve lower urinary tract symptoms (LUTS) 4, 5
• Chronic Prostatitis and Pelvic Pain Monitoring:
  • Regular check-ups with a urologist to monitor symptoms and adjust treatment as needed
• Health Anxiety Monitoring:
  • Regular check-ups with a mental health professional to monitor anxiety levels and adjust treatment as needed
• Adalimumab Therapy Monitoring:
  • Regular monitoring for side effects, such as injection site reactions, infections, and rare serious complications (e.g., tuberculosis, deep fungal infections) 6
  • Consideration of laboratory monitoring, including blood counts and liver function tests, to detect potential side effects 6
• Physical Exams:
  • Regular physical exams to monitor overall health and detect any potential complications
  • Prostate exams to monitor prostate size and symptoms
  • Abdominal exams to monitor for any potential complications related to Crohn's disease

It is essential to work with a healthcare team, including a gastroenterologist, urologist, and mental health professional, to develop a comprehensive monitoring and treatment plan.