Otezla (apremilast) is an oral prescription medication primarily used to treat moderate to severe plaque psoriasis, psoriatic arthritis (PsA), and oral ulcers associated with Behçet’s Disease. While its main function is to manage inflammation related to these chronic conditions, emerging research and patient experiences indicate a potential side effect of weight loss. This article explores the relationship between Otezla and weight loss, examining the clinical evidence, potential mechanisms, and considerations for patients.
What is Otezla?
Otezla, with the active ingredient apremilast, is a phosphodiesterase 4 (PDE4) inhibitor. It works by inhibiting the action of the PDE4 enzyme, which plays a crucial role in the body's inflammatory process. By reducing PDE4 activity, Otezla helps to modulate the immune response, providing relief from the pain and discomfort associated with psoriasis and psoriatic arthritis.
Approved by the FDA in 2014, Otezla offers a convenient tablet form, contrasting with earlier treatments like biologics that required injections or infusions. It is prescribed for adult patients with plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
Clinical Evidence of Weight Loss with Otezla
Research suggests that Otezla can lead to weight loss in some individuals. A study from the University of Pennsylvania indicated that Otezla could help people lose weight and reduce the risk of heart disease. In clinical trials, approximately 10-12% of patients taking Otezla experienced a 5-10% reduction in their body weight, compared to only 5% in the placebo group. Additionally, around 2% of patients treated with Otezla lost more than 10% of their body weight.
A pooled analysis of the ESTEEM 1 and ESTEEM 2 trials showed an average weight change of -1.51 kg (-3.33 lb) at week 16 for patients receiving Otezla 30mg twice daily. By week 52, about 19% of patients had lost more than 5% of their initial weight.
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A real-world analysis of 8250 patients initiating apremilast between March 2013 and November 2021, observed improvements in weight and HbA1c among obese and severely obese patients after a 6-month regimen of apremilast. Severely obese patients showed the most significant improvement in RAPID3 scoring, while obese patients reported a notable mean improvement per PGA.
A prospective, open-label study (Immune Metabolic Associations in Psoriatic Arthritis) of adults receiving apremilast 30 mg as part of routine care for PsA and/or psoriasis found that apremilast was associated with a mean weight loss of 2.2 kg and a mean BMI decrease of 0.8 kg/m2 after 6 months of treatment.
Potential Mechanisms Behind Weight Loss
The exact mechanism for weight loss with Otezla remains undetermined, but several theories exist. It is speculated that the phosphodiesterase (PDE4) inhibitory activity of Otezla may play a role. Some theories suggest that Otezla’s side effects, such as diarrhea and nausea, may lead to reduced food intake and water weight loss. These conditions can also result in poor nutrient absorption, contributing to weight loss.
Another theory suggests that Otezla may alter metabolism, although concrete evidence is still lacking. Additionally, mood changes like anxiety and depression, sometimes associated with Otezla, may affect a patient's appetite and, consequently, their body weight.
Managing Weight Loss While Taking Otezla
While some patients may view weight loss as a welcome side effect, it can be concerning or even dangerous for others, particularly those already at a healthy weight or underweight. It is crucial to monitor weight closely and consult with a healthcare team if weight loss becomes rapid or excessive.
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Steps to Promote Healthy Weight Management
- Dietary Assessment: Evaluate your diet to ensure adequate intake of nutrient-dense foods. Consider incorporating nuts, lean proteins, and avocados to maintain weight.
- Increase Protein Intake: Protein can help preserve muscle mass during weight loss.
- Consult a Dietitian: Seek personalized advice from a dietitian to address unique nutritional needs.
- Regular Health Check-ups: Prioritize regular health check-ups and bloodwork to stay informed about your health status.
Monitoring and When to Seek Medical Advice
Losing more than 5% of total body weight within a short period can significantly impact the body. Watch out for mood changes, gastrointestinal issues, or decreased energy levels, as these may indicate the need for an alternative treatment.
Other Side Effects of Otezla
Besides weight loss, Otezla may cause other side effects, including:
- Headache
- Upper respiratory infection
- Nausea or vomiting
- Diarrhea
- Depression
- Insomnia
Severe side effects may include severe diarrhea or vomiting, major depression, and severe allergic reactions. It is important to promptly discuss any persistent or severe side effects with your doctor.
Otezla Alternatives
There are alternatives to Otezla for treating psoriasis and psoriatic arthritis:
- Biologic Medications: These drugs, derived from living cells, target specific parts of the immune system. Examples include Enbrel, Humira, and Stelara.
- DMARDs (Disease-Modifying Antirheumatic Drugs): Traditional DMARDs like methotrexate and sulfasalazine are effective for psoriasis and arthritis but do not typically cause weight loss.
Lifestyle Modifications
- Anti-Inflammatory Diet: Following a healthy diet can improve joint conditions and protect against future problems.
- Regular Physical Activity: Incorporating physical activity can reduce stiffness and improve joint function.
- Stress Management: Managing stress can significantly improve quality of life.
Cost and Availability
Otezla is a brand-name medication, and the cost can be substantial. The cash price is around $5096 for a month's supply (60 tablets) using an online coupon. However, costs can vary based on pharmacy location, insurance coverage, and available discounts. Amgen, the manufacturer, offers the Otezla $0 Co-pay Card Program for eligible patients.
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It is also possible to purchase brand-name Otezla through online pharmacies like NorthWestPharmacy.com for potentially lower prices.
Otezla and Mental Health
Otezla's effects on mental health should not be overlooked. Mood changes, including anxiety and depression, can occur, which may indirectly affect appetite and weight.
When starting Otezla, it's crucial to establish acceptable weight loss ranges with your doctor and monitor your weight regularly. Consistent weigh-ins can help determine if the drug is causing you to lose weight.
Otezla Use in Children
Otezla is approved for treating moderate to severe plaque psoriasis in children ages 6 years and older who weigh at least 20 kilograms (about 44 pounds). During treatment, a doctor will monitor the child’s body weight and height for unexpected changes, and may recommend stopping the drug if growth changes occur.
Interactions with Other Substances
Alcohol is not known to directly interact with Otezla, but drinking alcohol while taking Otezla might worsen certain side effects like diarrhea, nausea, vomiting, headache, and fatigue.
Otezla can interact with medications that induce drug metabolism, such as carbamazepine, phenobarbital, phenytoin, primidone and rifampin. The herbal supplement St. John’s wort can also interact with Otezla, potentially making it less effective.