How to help manage two of the most common autoimmune diseases.
There are over 80 different autoimmune diseases that impact the some 50 million Americans who live with one of those diseases. The causes of many autoimmune diseases are unknown, but genetics, infections, and the environment may play a part. Unfortunately, there is generally no cure for autoimmune diseases; however, there are medications and lifestyle modifications that can help to manage the conditions. Pharmacists can play an important role through an interdisciplinary approach in managing patients with autoimmune diseases. This article will focus on two common autoimmune diseases and what pharmacists need to know about them: celiac disease and systemic lupus erythematosus (SLE).
Celiac Disease Management, Counseling Points, and Treatments on the Horizon
Celiac disease is an immune reaction, in the form of gastrointestinal (GI) symptoms, to eating gluten. There are different theories regarding the cause of celiac disease, which include genetics, GI infections, and stress; however, the exact cause is unknown. Approximately 1 in 100 individuals are diagnosed with celiac disease globally, and about 2.5 million Americans are undiagnosed, which can ultimately lead to long-term complications.
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GI symptoms may include: diarrhea, weight loss, bloating and gas, abdominal pain, nausea and vomiting, and constipation. Celiac disease can also cause various non-GI symptoms, including: anemia, osteoporosis, skin rash, mouth ulcers, headaches, fatigue, nervous system problems, joint pain, and altered spleen function. Serology and genetic blood testing along with an endoscopy can help to diagnose celiac disease.
The gold standard for managing celiac disease is adhering to a gluten-free diet, as chronic inflammation can cause damage to the inner lining of the small intestine. Gluten is a protein found in wheat, barley, and rye. Additionally, the FDA specifies that food carrying “gluten-free” labels must contain less than 20 parts per million of gluten. However, even trace amounts of gluten can cause GI issues.
Pharmacists can play an important role in guiding patients to select appropriate gluten-free foods and medications. Educate patients to always read product packaging to ensure they are labeled as gluten-free or have no gluten-containing ingredients (Table). Patients may have questions about whether their medications contain gluten. Most drug products contain gluten-free starches (e.g., corn, potato, rice).
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Medications won’t usually advertise the word gluten, so it’s important to focus on the ingredients which can be found through the product information on sites such as DailyMed, Gluten Free Drugs, or Pillbox. The drug manufacturer can also be contacted for additional information. If gluten is contained in an oral drug product, the amount is generally less than 0.5 mg per unit dose, which is considered less than a serving of gluten-free food.
Patients with celiac disease may require vitamin and mineral supplements (e.g., iron) if anemia or other nutritional deficiencies occur. Medications may be used to alleviate inflammation, which include steroids (e.g., budesonide) and immunosuppressive drugs (e.g., azathioprine). Dapsone may be used to treat the skin rash dermatitis herpetiformis, which can occur in patients with celiac disease. Pharmacists can educate patients that frequent blood tests are needed while receiving treatment with dapsone and immunosuppressive medications to monitor for adverse effects.
According to a study published in the Journal of Pediatrics, use of text messaging was an effective intervention to improve patients’ quality of life, ability to manage their condition, work with healthcare providers, and prevent disease exacerbation. This may offer an effective technique for pharmacists and other members of the healthcare team to monitor diet adherence in patients with celiac disease.
There are currently no FDA-approved medication treatments for celiac disease. However, there is a promising drug in the pipeline, larazotide acetate, that has received fast track designation and belongs to a new class of drugs known as tight junction regulators. Larazotide works by decreasing inflammation in the intestine triggered by gluten, and it is currently in a phase 3 trial that is expected to enroll about 600 patients.
SLE Management and Pipeline Drugs
According to the Lupus Foundation of America, approximately 5 million people globally are affected by lupus and about 16,000 new cases are reported annually. Lupus occurs when the body’s immune system attacks the tissues and organs, which can affect various body systems. Diagnosis is determined through a multifaceted approach with the combination of blood and urine tests, signs and symptoms, and physical examination. Symptoms generally include fatigue, fever, joint pain, photosensitivity, and a butterfly-shaped rash. Systemic lupus erythematosus (SLE) is the most common form of the four types of lupus.
According to a study published in Arthritis Research & Therapy, transitional care improved self-care and quality of life in SLE patients and reduced hospital readmissions. Pharmacists can play an important role in managing chronic medications for patients with SLE. NSAIDs, such as naproxen and ibuprofen, may be used for pain and swelling associated with SLE. Counseling points include an increased risk of cardiovascular and kidney adverse effects as well as stomach ulcers, which can occur even on short-term therapy with NSAIDs.
Hydroxychloroquine, the antimalarial drug, is commonly prescribed to decrease lupus flares. Side effects may include GI issues and damage to the retina, so it should be taken with food and patients should see an ophthalmologist prior to starting hydroxychloroquine.
Corticosteroids (e.g., prednisone) may be used to reduce inflammation, and adverse effects may include weight gain, osteoporosis, hypertension, diabetes, glaucoma, and increased risk of infection. Immunosuppressants such as azathioprine and mycophenolate mofetil are also used for severe SLE cases, and potential adverse effects may include infection risk, liver damage, decreased fertility, and an increased risk of cancer.
The biologic belimumab (Benlysta) was approved in 2011 for SLE in adults and received approval April 2019 as the first treatment for SLE in pediatric patients. The most common side effects associated with Benlysta include nausea, diarrhea, fever, and infusion reactions. Pharmacists should recommend that patients receive an antihistamine prior to Benlysta infusions to prevent a reaction.
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Adrijana Kekic, PharmD, BCACP, Pharmacogenomics Pharmacist at the Mayo Clinic College of Medicine and Science, Phoenix, AZ, uses pharmacogenomics testing when making medication recommendations for patients with SLE with a personalized medicine approach. One example Kekic provided was thiopurine methyltransferase (TPMT) genotyping prior to initiating treatment with azathioprine, which facilitates identifying patients who are at increased risk for toxicity. Kekic also provides counseling tips as part of her patient consultations. “I recommend exercise and stress reduction for my SLE patients,” says Kekic, which can help improve energy and decrease lupus flares.
There are various drugs in the pipeline for SLE in phase 3 clinical trials, according to Kekic. Baricitinib (Olumiant) is FDA approved for rheumatoid arthritis and has been granted fast track status for the treatment of SLE.
One promising therapy rigerimod (Lupuzor), a novel biologic, failed to meet the primary endpoint in a phase 3 study based on clinical trial results reported in 2018. However, rigerimod met the primary objective of the open label extension study evaluating the safety and tolerability of the drug in patients with SLE, demonstrating no serious adverse effects in 62 patients. However, further studies are necessary with a larger number of study participants to determine the rigerimod’s fate.