As someone who has been on the front lines of caring for people with inflammatory bowel disease (IBD) for a cumulative 25+ years, I've witnessed a remarkable evolution in not only the treatment options used to manage the disease, but also how we approach patient care. We've moved well beyond just trying to extinguish the fire—addressing the immediate symptoms as quickly as possible—to a more holistic approach that targets underlying mechanisms of the disease, considers the entire patient journey, and ultimately, improves outcomes.
The incorporation of a multidisciplinary healthcare team has played a significant role in this shift and improvement in patient care. I started my career as a registered nurse and then transitioned to a nurse practitioner, also known as a type of advanced practice provider (APP). This allows me to go more in-depth in a hands-on way, providing some of the same medical interventions as a physician to help guide medical decisions. It's truly incredible to see how the APP role has evolved from treating the disease to treating the whole person, and how empowered patients, and APPs, are today at the forefront of the treatment decision-making process.
Challenges in IBD Management
IBD—which includes Crohn's disease and ulcerative colitis—is characterized by chronic inflammation of the digestive tract, with an average age of onset between 20 and 30 years old. can cause abdominal pain, weight loss, loss of appetite, fatigue, and loose or more urgent bowel movements, among other symptoms. While ulcerative colitis affects the colon and rectum, can affect any part of the gastrointestinal tract, and symptoms vary among patients based on their specific form of the disease. IBD symptoms can take a , interfering with school, work, relationships, and starting a family.
It can be a long and challenging process to confirm an IBD diagnosis and then to further distinguish between Crohn's disease and ulcerative colitis. Diagnosing IBD requires a multidisciplinary approach, involving a range of tests and evaluation of symptoms that may cause frustration for patients looking for answers and relief. That's why as a nurse practitioner, I work closely with patients to ask questions and understand their specific symptoms, needs, and treatment goals in both the short and long term.
The Need for Individualized Treatment Plans
Over the last decade, greater research and understanding of IBD has led to the influx of novel IBD treatments and therapeutic approaches. These new therapies have provided patients with more options of clinical significance. But to give patients the best care, it's crucial we utilize a tailored treatment approach that helps them reach their goals—such as the freedom to not worry about urgently finding a bathroom when traveling.
When developing a multidisciplinary treatment approach, we conduct a comprehensive assessment of the needs, habits, and experiences of each patient, including their clinical history, diet, lifestyle, and coping skills. We assess the severity of their symptoms and the presence of complications such as fibrosis and fistulas, as well as comorbidities and extraintestinal symptoms.
Working together in a holistic decision-making team is the best way to approach advances in IBD treatment. I consider the patient as the captain of this team, and our role is to guide them with as much information and support as possible. Ongoing and honest communication with the patient enables us to see how they respond to a particular treatment and quickly change course if warranted.
It is also helpful to have therapies with a safety profile I'm familiar with and that I have a great deal of experience with. One such medication is the biologic , approved for adults in the treatment of moderately to severely active Crohn's disease or ulcerative colitis.
When discussing a treatment plan with a patient, achieving long-term sustainable remission and factoring in safety are often considered the top priorities. The efficacy and safety of STELARA® were studied in both induction and maintenance trials as well as in the long-term extension through five years for Crohn's disease and four years for ulcerative colitis. (Click for Crohn's disease data and for ulcerative colitis data to see the full results.)
STELARA® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or excipients. Serious adverse reactions have been reported in STELARA®-treated patients, including bacterial, mycobacterial, fungal, and viral infections, malignancies, hypersensitivity reactions, Posterior Reversible Encephalopathy Syndrome (PRES), and noninfectious pneumonia. STELARA® should not be given to patients with any clinically important active infection. Patients should be evaluated for tuberculosis prior to initiating treatment with STELARA®. Live vaccines should not be given to patients receiving STELARA®. If PRES is suspected or if noninfectious pneumonia is confirmed, discontinue STELARA®. Please see related and other Important Safety Information below.
The long-term efficacy and safety profile of STELARA® make it a therapy I can, and do, recommend to many of my patients.
All said, the outlook for the IBD community is extremely bright, with more options available than we've ever seen before. As healthcare professionals navigating the evolving IBD landscape and treatment options, patients are the north star—not just their symptoms. We should continue to remember what these clinical advances mean for patients when identifying a treatment option at the beginning and throughout their patient journey.
Kim Kearns, MS, APN, is a nurse practitioner specializing in adult gastroenterology. Kearns was paid honoraria by Johnson & Johnson for drafting this article.
Indications
STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.
STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
Important Safety Information
STELARA® (ustekinumab) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients.
Infections
STELARA® may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections requiring hospitalization or otherwise clinically significant infections were reported. In patients with plaque psoriasis, these included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. In patients with psoriatic arthritis, this included cholecystitis. In patients with Crohn's disease, these included anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and Listeria meningitis. In patients with ulcerative colitis, these included gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.
Treatment with STELARA® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA® in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA® and discontinue STELARA® for serious or clinically significant infection until the infection resolves or is adequately treated.
Theoretical Risk for Vulnerability to Particular Infections
Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA® may be susceptible to these types of infections. Consider diagnostic testing, e.g., tissue culture, stool culture, as dictated by clinical circumstances.
Pre-Treatment Evaluation of Tuberculosis (TB)
Evaluate patients for TB prior to initiating treatment with STELARA®. Do not administer STELARA® to patients with active tuberculosis infection. Initiate treatment of latent TB before administering STELARA®. Closely monitor patients receiving STELARA® for signs and symptoms of active TB during and after treatment.
Malignancies
STELARA® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among patients who received STELARA® in clinical trials. The safety of STELARA® has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA® who had risk factors for developing non-melanoma skin cancer (NMSC). All patients receiving STELARA®, especially those >60 years or those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.
Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA®. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA®.
Posterior Reversible Encephalopathy Syndrome (PRES)
Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.
Monitor all patients treated with STELARA® for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STELARA®.
Immunizations
Prior to initiating therapy with STELARA®, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STELARA® should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with STELARA® or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STELARA® because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of STELARA® may not elicit an immune response sufficient to prevent disease.
Noninfectious Pneumonia
Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA®. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and, in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue STELARA® and institute appropriate treatment.
Allergen Immunotherapy
STELARA® may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.
Most Common Adverse Reactions
The most common adverse reactions (≥3% and higher than that with placebo) in adults from plaque psoriasis clinical trials for STELARA® 45 mg, STELARA® 90 mg, or placebo were: nasopharyngitis (8%, 7%, 8%), upper respiratory tract infection (5%, 4%, 5%), headache (5%, 5%, 3%), and fatigue (3%, 3%, 2%), respectively. The safety profile in pediatric patients with plaque psoriasis was similar to that of adults with plaque psoriasis. In psoriatic arthritis (PsA) trials, a higher incidence of arthralgia and nausea was observed in patients treated with STELARA® when compared with placebo (3% vs 1% for both). In Crohn's disease induction trials, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 8 for STELARA® 6 mg/kg intravenous single infusion or placebo included: vomiting (4% vs 3%). In the Crohn's disease maintenance trial, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 44 for STELARA® 90 mg subcutaneous injection or placebo were: nasopharyngitis (11% vs 8%), injection site erythema (5% vs 0%), vulvovaginal candidiasis/mycotic infection (5% vs 1%), bronchitis (5% vs 3%), pruritus (4% vs 2%), urinary tract infection (4% vs 2%), and sinusitis (3% vs 2%). In the ulcerative colitis induction trial, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 8 for STELARA® 6 mg/kg intravenous single infusion or placebo included: nasopharyngitis (7% vs 4%). In the ulcerative colitis maintenance trial, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 44 for STELARA® 90 mg subcutaneous injection or placebo included: nasopharyngitis (24% vs 20%), headache (10% vs 4%), abdominal pain (7% vs 3%), influenza (6% vs 5%), fever (5% vs 4%), diarrhea (4% vs 1%), sinusitis (4% vs 1%), fatigue (4% vs 2%), and nausea (3% vs 2%).
Please see full and for STELARA®. Provide the Medication Guide to your patients and encourage discussion.
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