What exams, blood work, and monitoring should my primary care physician (PCP) perform during 6-month checkups for a patient with a history of Crohn's disease, benign prostatic hyperplasia (BPH), prostatitis, and hypertension, who is taking Humira (adalimumab)?

From the Guidelines

For a patient with Crohn's disease, BPH, prostatitis, and hypertension on Humira, your PCP should perform comprehensive monitoring every six months, including a complete blood count, comprehensive metabolic panel, C-reactive protein, fecal calprotectin, and tuberculosis screening annually. This monitoring is crucial for detecting complications early and ensuring the safe and effective use of Humira, as recommended by recent guidelines 1. The comprehensive metabolic panel will assess kidney and liver function, while the C-reactive protein and fecal calprotectin will monitor Crohn's inflammation. Blood pressure measurements are essential for hypertension management, and PSA testing and digital rectal exams will help monitor prostate conditions. Urinalysis can detect urinary tract infections that may complicate prostatitis. A thorough physical examination, including abdominal assessment for Crohn's symptoms, and evaluation for any Humira injection site reactions or signs of infection, is also necessary. A medication review is important to ensure all treatments remain appropriate and effective, as suggested by the Canadian Association of Gastroenterology clinical practice guideline for the management of luminal Crohn's disease 1. Your doctor may adjust this schedule based on your specific symptoms, disease activity, and response to treatment. Key aspects of the monitoring regimen include:

• Complete blood count to check for anemia or infections
• Comprehensive metabolic panel to assess kidney and liver function
• C-reactive protein and fecal calprotectin to monitor Crohn's inflammation
• Tuberculosis screening annually due to Humira's immunosuppressive effects
• Blood pressure measurements for hypertension management
• PSA testing and digital rectal exams to monitor prostate conditions
• Urinalysis to detect urinary tract infections that may complicate prostatitis
• Thorough physical examination, including abdominal assessment for Crohn's symptoms
• Evaluation for any Humira injection site reactions or signs of infection
• Medication review to ensure all treatments remain appropriate and effective.

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.

The patient's primary care physician (PCP) should perform the following exams, blood work, and monitoring at 6-month checkups:

• Latent TB test: to monitor for active TB, even if the initial test was negative 2
• Monitoring for serious infections: such as tuberculosis, bacterial sepsis, invasive fungal infections, and other opportunistic pathogens 2
• Blood work: to monitor for signs of infection, malignancy, or other adverse effects of adalimumab treatment, although specific blood work is not mentioned in the label It is essential to note that the provided drug labels do not explicitly outline a comprehensive monitoring plan for patients with Crohn's disease, BPH, prostatitis, and hypertension taking adalimumab. Therefore, the above recommendations are based on the available information and may not be exhaustive. 2 2

From the Research

Exams and Monitoring for Crohn's Disease

• Fecal calprotectin (FC) and C-reactive protein (CRP) levels should be monitored to assess inflammatory activity in Crohn's disease, as shown in a study published in Gastroenterologia y hepatologia 3
• The combined use of FC and CRP can provide a more accurate assessment of inflammatory activity, with a sensitivity of 96% and accuracy of 78% for FC, and a sensitivity of 75% and specificity of 67% for CRP 3
• Serum calprotectin levels can also be used as an inflammatory marker, with higher levels observed in patients with Crohn's disease, particularly during active disease 4

Exams and Monitoring for Prostate Health

• Patients with a history of benign prostatic hyperplasia (BPH) and prostatitis should be monitored for prostate cancer risk, as some studies suggest an increased risk of prostate cancer in patients with inflammatory bowel disease (IBD) 5
• A comprehensive daily six-month home-based patient empowerment program, such as PC-PEP, may lead to weight loss and improved overall health in men with prostate cancer 6

Blood Work and Monitoring for Hypertension

• Regular blood pressure checks should be performed to monitor hypertension
• Blood work, such as complete blood counts and metabolic panels, should be performed regularly to monitor overall health and potential side effects of medications, such as Humira (adalimumab)

Additional Monitoring

• Patients taking Humira (adalimumab) should be monitored for potential side effects, such as infections and allergic reactions
• Regular check-ups with a primary care physician (PCP) every 6 months can help monitor overall health and adjust treatment plans as needed, based on studies such as the development and validation of a test to monitor endoscopic activity in patients with Crohn's disease based on serum levels of proteins 7