What is the use of Otezla (Apremilast)?

From the Guidelines

Otezla (apremilast) should be initiated at a lower dose of 10mg, titrated up over 5 days to reduce gastrointestinal adverse effects, and then dosed at 30mg by mouth twice daily. This dosing regimen is based on the joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies 1. The medication is metabolized in the liver by cytochrome P450, and its use with strong inducers of cytochrome P450, such as rifampin, phenobarbital, carbamazepine, and phenytoin, is not recommended due to decreased efficacy 1.

Some key points to consider when prescribing Otezla include:

• Common adverse effects, such as diarrhea, nausea, upper respiratory tract infections, and headache, which are more pronounced in patients 65 and older, who are also prone to dehydration and its complications 1
• The potential for apremilast to be associated with the emergence or worsening of depression, necessitating a discussion of this risk with patients before initiating therapy 1
• The need to reduce the dose to 30mg once daily in patients with severe renal impairment (creatinine clearance < 30 mL/min) 1
• Regular monitoring of weight, as a small percentage of patients may experience weight loss on apremilast, and discontinuation should be considered if weight loss exceeds 5% from baseline 1

Overall, Otezla is a beneficial treatment option for moderate to severe plaque psoriasis and psoriatic arthritis, offering the advantages of oral administration and no requirement for laboratory monitoring 1. However, it is essential to carefully evaluate the potential benefits and risks, particularly in patients with a history of depression or those taking strong CYP450 inducers.

From the FDA Drug Label

1 INDICATIONS AND USAGE 1.2 Psoriasis Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

INDICATIONS AND USAGE Apremilast, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. (1.2) APREMILAST tablets, for oral use Initial U. S. Approval: 2014 INDICATIONS AND USAGE Apremilast, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. (1. 2)

Otezla (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy 2, 2, 2.

• The recommended dose is 30 mg twice daily, with a titration schedule to reduce the risk of gastrointestinal symptoms.
• Contraindications include known hypersensitivity to apremilast or any excipients in the formulation.
• Warnings and precautions include diarrhea, nausea, and vomiting, depression, weight decrease, and drug interactions with strong cytochrome P450 enzyme inducers.

From the Research

Otezla Overview

• Otezla, also known as apremilast, is an orally administered, small molecule inhibitor of phosphodiesterase 4 (PDE4) 3, 4.
• It is indicated for the treatment of adults with psoriasis and psoriatic arthritis (PsA) 4.

Efficacy in Psoriasis and Psoriatic Arthritis

• Apremilast has been shown to reduce the severity of moderate to severe plaque psoriasis, including nail, scalp, and palmoplantar manifestations, versus placebo in adults 3, 4.
• It has also been shown to improve signs and symptoms of PsA, including enthesitis, dactylitis, physical function, and fatigue, in adults with active disease despite treatment with conventional synthetic and/or biologic disease-modifying anti-rheumatic drugs 3, 4.
• Apremilast has demonstrated significant efficacy versus placebo at Week 16 in biologic-naive patients with psoriasis, which was sustained over 52 weeks 5.

Combination Therapy

• Apremilast can be safely and effectively combined with phototherapy, systemic, and/or biological agents in patients with plaque psoriasis not responding adequately to these agents alone 6.
• A case study reported a patient with recalcitrant psoriasis achieving near-complete remission after therapy with a combination of adalimumab and apremilast 7.

Safety and Tolerability

• Apremilast is generally well tolerated, with the most common adverse events being diarrhea, nausea, upper respiratory tract infection, and nasopharyngitis 3, 4, 5.
• Diarrhea and nausea generally resolve in the first month of treatment 5.
• No new safety or tolerability issues were observed with apremilast through Week 52 5.