Apremilast (Otezla):7 Tablets
Drug class: DMARD, phosphodieasterase 4 (PDE4) inhibitor
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Explore This IssueApril 2019
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Warnings & Precautions
- Depression: Individuals should be alerted to watch for the emergence or worsening of depression, suicidal thoughts or other mood changes. If these changes occur, they should contact their physician. Carefully weigh the risks and benefits of apremilast treatment in patients with a history of depression and/or suicidal thoughts or behavior.
- Weight decrease: Weight should be regularly monitored. If unexplained or clinically significant weight loss occurs, consider discontinuing apremilast.
- Drug interactions: Using apremilast with strong cytochrome P450 (CYP 450) enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended due to potential loss of efficacy.
Commentary: The safety and effectiveness of apremilast was evaluated in three clinical trials involving 1,493 patients with active PsA. In the trials, study participants were randomly assigned placebo or 20 or 30 mg apremilast twice daily. Patients were able to continue with DMARDs, low-dose corticosteroids or NSAIDs during the trial. The primary endpoint was ACR 20 response at Week 16. Apremilast plus DMARDs compared with placebo plus DMARDs was associated with greater improvement in signs and symptoms of PsA. Evidence of greater improvement in physical function was also apparent with apremilast (30 mg twice daily) compared with placebo. The most common adverse reactions (≥5%) are diarrhea, nausea and headache.
*Important Safety Information (ISI)
This ISI is applicable to all tumor necrosis factor inhibitors (TNFi’s) and some other immune modulators.
Serious Infections & Malignancies
- There is an increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis) and infections due to other opportunistic pathogens. If these develop, discontinue the drug.
- Before starting treatment, perform a test for latent tuberculosis (TB); if positive, start treatment for TB prior to starting the drug. Monitor all patients for development of active TB during treatment, even if the initial latent TB test was negative.
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNFi’s.
Etanercept (Enbrel):8 Injection
Biosimilar(s): etanercept-szzs (Erelzi)9
Drug class: DMARD, TNFi
Boxed warning: *Refer to *ISI (above)
Warnings & Precautions
- Do not start etanercept during an active infection. If an infection develops, monitor carefully, and stop etanercept if the infection becomes serious.
- Consider empiric anti-fungal therapy for patients at risk (those who reside in or travel to regions where mycoses are endemic) for invasive fungal infections or who develop a severe systemic illness on etanercept.
- Demyelinating disease, exacerbation or new onset, may occur.
- Cases of lymphoma have been observed in patients receiving TNFi’s.
- Congestive heart failure, worsening or new onset, may occur.
- Advise patients to seek immediate medical attention if symptoms of pancytopenia or aplastic anemia develop, and consider stopping etanercept.
- Monitor hepatitis B virus carriers for reactivation during and following therapy. If reactivation occurs, consider stopping etanercept and beginning anti-viral therapy.
- Anaphylaxis or serious allergic reactions may occur.
- Stop etanercept if lupus-like syndrome or autoimmune hepatitis develops.
Commentary: The U.S. Food and Drug Administration (FDA) approved etanercept for the reduction of signs and symptoms in patients with active PsA. The approval was based on two clinical trials, both comparing the efficacy of etanercept vs. placebo. The most common adverse reactions (≥5%) are infections and injection-site reactions.