By Gary M. White, MD
Note: This is a summary only. Please consult the latest information when prescribing.
- FDA-approved for moderate to severe psoriasis as well as psoriatic arthritis.
- Common side effects include diarrhea, headache, and nausea which peak about two weeks into therapy and then tend to improve.
- No need for laboratory monitoring or alcohol consumption restrictions. No category X classification, or immunosuppressive infection or cancer risk. No evidence of potential for reactivation of tuberculosis.
- Mechanism of action includes selective inhibition of phosphodiesterase 4 (PDE4).
- PASI 75 is achieved in 33% of patients in the first 4 months [J Am Acad Dermatol. 2014;70(suppl 1):AB164].
- In Phase III studies, one in five patients lost more than 5% body weight. The weight loss continued through 65 weeks of therapy and then plateaued.
- Effective for nail and scalp psoriasis.
- Patients have used apremilast for up to 5 years in studies with good results. Side effects are mild-moderate and discontinuation rates are low [JAAD 2015;73;37].
- Apremilast seems particularly good for nail and scalp psoriasis [JAAD 2015 Published online Nov 5th Rich et al].
Indications for Adults 18 Years of Age or Older
- Active psoriatic arthritis
Mechanism of Action
Inhibits PDE4 but full mechanism of action is not fully understood.
Efficacy in Psoriasis
- Lower in comparison to the biologics.
- 33% PASI 75 at week 16. After 16 weeks, PASI 75 levels off.
- Effective for nail and scalp psoriasis [JAAD 2016;74;134].
Trade Name in US
- 30 mg po BID
- Reduce to 30 mg QAM for severe renal impairment.
Warnings and Precautions
Depression occurred in 1.3% of patients on Otezla compared with 0.4% of patients on placebo.
Adverse Reactions (Otezla %, placebo %)
- Weight decrease 5-10% (12,5)
- Weight decrease > 10% (2,1)
- Diarrhea (17,6)
- Nausea (17,7)
- URI (9,6)
- Tension Headache (8,4)
- Headache (6,4)
- Depression (1.3,0.4)
There is some interest and some data that apremilast can improve atopic dermatitis. [Arch Dermatol. 2012 Aug;148(8):890-7].
Multiple lentigines have occurred in patients with psoriasis treated with apremilast (in this report, a total of 5) [JAAD 2016;75;1251]. All cases occurred in the first four months of treatment only on psoriatic lesions that had regressed. None of the patients received phototherapy, and lentigines appeared in most cases in sun-protected areas. Lentigines were still present five years after their occurrence.
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