Apremilast

Apremilast Brand Name– Otezla

What is Apremilast

Apremilast is an oral phosphodiesterase-4 (PDE4) inhibitor and is considered a targeted synthetic DMARD (tsDMARD).

The drug is indicated for use in adults oral ulcers associated with Behcet’s Disease, moderate-to-severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, and for adults with active psoriatic arthritis (PsA).

The drug has also been shown to be effective in treating psoriasis of the nails, dactylitis, and enthesitis.

Psoriasis treatment guidelines recommend the use of PDE4 inhibitors as an initial treatment option for plaque psoriasis, and also recommend the use of apremilast for adults with plaque psoriasis in whom other standard DMARD treatments have been unsuccessful.

Apremilast has been studied in large clinical trials for PsA and reduces the clinical manifestations of PsA, but the drug is not considered as efficacious as biologic therapies. Compared to biologic agents commonly used for PsA (e.g., TNF-blockers, interleukin-targeted treatments), definitive evidence of apremilast efficacy for reducing the progression of radiographic damage is lacking.

Most PsA guidelines position apremilast as an alternative limited to patients who failed to reach the treatment target on conventional DMARDs and for whom biologic treatments may be contraindicated or inappropriate.

In adult patients with active PsA and predominant enthesitis who are naive to conventional DMARDs and biologics, apremilast may be considered as an option.

Compared to traditional DMARDs for PsA, apremilast does not require routine therapeutic drug monitoring. However, the drug is expensive and thus is often considered second line in comparison to conventional DMARD therapies.

Apremilast is often used in conjunction with other conventional DMARDs to try to optimize treatment, given its relatively low evidence for efficacy when used alone.

Use of the drug has been associated with cases of severe diarrhea, nausea, and vomiting; some requiring hospitalization. If these symptoms develop during treatment, consider reducing the dosage or suspending therapy.

Indications

  1. aphthous ulcer
  2. Behcet’s syndrome
  3. psoriasis
  4. psoriatic arthritis

For the treatment of active psoriatic arthritis

Side Effects

  1. abdominal pain
  2. anorexia
  3. arthralgia
  4. back pain
  5. cough
  6. depression
  7. diarrhea
  8. dyspepsia
  9. fatigue
  10. folliculitis
  11. gastroesophageal reflux
  12. headache
  13. infection
  14. insomnia
  15. migraine
  16. nausea
  17. pharyngitis
  18. rash
  19. suicidal ideation
  20. vomiting
  21. weight loss

Monitoring Parameters

  • serum creatinine
  • weight

Contraindications

  • breast-feeding
  • children
  • dehydration
  • depression
  • diarrhea
  • geriatric
  • hypovolemia
  • labor
  • pregnancy
  • renal failure
  • renal impairment
  • suicidal ideation
  • vomiting

Interactions

  • Acetaminophen; Butalbital
  • Acetaminophen; Butalbital; Caffeine
  • Acetaminophen; Butalbital; Caffeine; Codeine
  • Amobarbital
  • Apalutamide
  • Aspirin, ASA; Butalbital; Caffeine
  • Aspirin, ASA; Butalbital; Caffeine; Codeine
  • Atropine; Hyoscyamine; Phenobarbital; Scopolamine
  • Barbiturates
  • Belladonna Alkaloids; Ergotamine; Phenobarbital
  • Butabarbital
  • Carbamazepine
  • Enzalutamide
  • Fosphenytoin
  • Isoniazid, INH; Pyrazinamide, PZA; Rifampin
  • Isoniazid, INH; Rifampin
  • Lumacaftor; Ivacaftor
  • Lumacaftor; Ivacaftor
  • Mephobarbital
  • Methohexital
  • Mitotane
  • Pentobarbital
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Rifampin
  • Secobarbital
  • St. John’s Wort, Hypericum perforatum
  • Thiopental
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