|Year : 2019 | Volume
| Issue : 1 | Page : 63-65
Viva voce on apremilast
Uday S Khopkar1, Kinjal Deepak Rambhia2
1 Department of Dermatology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
2 Department of Dermatology, HBT Medical College and Dr. RN Cooper Hospital, Mumbai, Maharashtra, India
|Date of Web Publication||22-Jul-2019|
Dr. Kinjal Deepak Rambhia
B-105 Kalpataru Classic, Chincholi Bunder Road, Malad West, Mumbai - 400 064, Maharashtra
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Khopkar US, Rambhia KD. Viva voce on apremilast. Indian J Drugs Dermatol 2019;5:63-5
1. What are the indications for which you have used apremilast?
Dr. Uday Khopkar: The most common indication for which I have used apremilast is psoriasis.
Among the different types of psoriasis, I have used in guttate or eruptive psoriasis, unstable psoriasis (though not the pustular type), and chronic plaque psoriasis. I have also used apremilast in a few patients having psoriasis with concomitant atopic diathesis or atopic dermatitis. However, its efficacy in atopic dermatitis is not as much as in psoriasis.
The other indications for which apremilast has been used are shown in [Box 1].
2. What are the clinical scenarios in psoriasis where you will prefer apremilast over other systemic immunosuppressants such as methotrexate or cyclosporine?
Dr. Uday Khopkar: Patients having mild-to-moderate psoriasis, eruptive psoriasis, and chronic plaque psoriasis progressing to unstable psoriasis (not pustular variety) generally respond well to apremilast treatment in my opinion. Apremilast can also be considered in individuals not responding to topical treatment or where immunosuppressants such as cyclosporine or methotrexate have to be avoided.
3. Which forms of psoriasis give unsatisfactory results to apremilast according to you?
Dr. Uday Khopkar: In my experience, the following types of psoriasis do not show satisfactory response to apremilast:
- Pustular psoriasis
- Chronic plaque psoriasis with thick scales where the response is delayed
- Scalp involvement frequently responds incompletely
- Nail psoriasis is slow to respond.
4. Do you perform any investigations before starting a patient on apremilast?
Dr. Uday Khopkar: Initially, when I started using apremilast, I used to advise complete hemogram and liver and renal function tests as baseline investigations. Later, in my practice, I gradually observed no change in these parameters in my patients. Now, I suggest these investigations to my patients only if I am combining apremilast with other drugs such as methotrexate or acitretin.
5. What are the most common adverse effects to apremilast noted/seen in your practice?
Dr. Uday Khopkar: The major issue in prescribing apremilast to patients is the side effects. Although the side effects are rarely severe, they are troublesome to the patients. Diarrhea, nausea, vomiting, abdominal pain, headache, weight loss, dizziness, and fainting episodes have all occurred in some of my patients. Earlier when I initiated my patients with the twice daily regimen, a few of my patients had such severe diarrhea that they had to be hospitalized for intravenous fluid therapy. Also, one of my patients who was on methotrexate and apremilast combination therapy for >6 months complained of severe weight loss and reduced appetite, was investigated further, and was diagnosed with an intra-abdominal malignancy.
[Table 1] shows the list of adverse effects seen due to apremilast.
6. What is the longest duration that you have administered apremilast without any side effects?
Dr. Uday Khopkar: The major limiting factor for the long-term use of apremilast is the gastrointestinal adverse effects. For about 50% of patients who tolerated the medicine well, I have continued the treatment for more than 6 months to 1 year. However, I have noticed that the effects of apremilast tend to plateau out after a certain time.
7. Which other drugs have you used in combination with apremilast in your practice?
Dr. Uday Khopkar: In my practice, I have combined methotrexate or acitretin with apremilast and found reasonably good response without any side effects. I have not had the opportunity to combine apremilast with biologics much due to the expense of biologics. Further, I do not recommend combining apremilast with cyclosporine due to increased risk of gastrointestinal side effects. I have not combined apremilast with phototherapy in my patients, but I feel it can be done if facilities for phototherapy are available.
However, one must be extra cautious and monitor the patients' laboratory parameters (complete hemogram and liver and renal function tests) when combining these drugs.
[Box 2] provides the list of combination treatments of apremilast with other drugs described in literature.
8. How would you rate the onset of action of apremilast in comparison to methotrexate, cyclosporine, and acitretin?
Dr. Uday Khopkar:
- In unstable plaque psoriasis from rapid to slow onset of action, cyclosporine – apremilast – methotrexate – acitretin
- In pustular psoriasis, acitretin – cyclosporine – methotrexate – apremilast
- In palmoplantar psoriasis, acitretin – cyclosporine – methotrexate – apremilast.
9. What was your experience of using apremilast in the following types of psoriasis:
Dr. Uday Khopkar:
- Nail psoriasis: My experience with the use of apremilast in nail psoriasis is limited, but I have not seen much improvement in the nail findings with apremilast when administered for generalized psoriasis
- Palmoplantar psoriasis: Apremilast is not as effective as acitretin or methotrexate in palmoplantar psoriasis
- Scalp psoriasis: Improves with apremilast treatment, but rarely completely
- Pustular psoriasis: Does not respond well to apremilast treatment
- Psoriatic arthritis: Apremilast has shown moderate improvement in joint symptoms in psoriatic arthritis. However, in my opinion, the response is inferior to that of methotrexate in psoriatic arthritis.
10. What are the contraindications of apremilast?
Dr. Uday Khopkar:
- Known hypersensitivity to the active substance or any of its excipients
I use apremilast with extreme caution in geriatric population due to the higher incidence of gastrointestinal side effects and their proneness for water and electrolyte disturbance. I have also noticed that apremilast in the regular adult dose is not tolerated well by women of all age groups. Hence, I try to avoid using this drug in the regular dosage in female patients. I have no experience of using apremilast in the pediatric age group as of now.
11. What are the drug interactions to be kept in mind?
Dr. Uday Khopkar: When apremilast is coadministered with strong inducers of CYP3A4 enzyme (rifampicin, carbamazepine, phenytoin, and phenobarbitone), it reduces clinical response in patients of psoriasis.
12. What are your views on use of apremilast in the following clinical scenarios?
Dr. Uday Khopkar:
- Pregnancy – contraindicated
- Lactation – contraindicated
- Geriatric patients – use with caution as gastrointestinal side effects may have serious consequences and less tolerance to the medication
- Pediatric patients – I have not used apremilast for pediatric patients till now
- Liver function derangement – Can be used but with strict monitoring of laboratory parameters (liver function tests)
- Renal function derangement – Dose adjustment is recommended, use with caution, lower dosages, strict monitoring of renal function tests, and be vigilant to diagnose side effects early as they are prone to electrolyte disturbances.1
13. Do you think the dose for Indian population should be modified?
Dr. Uday Khopkar:
After treating my initial 25-odd psoriasis patients with apremilast, I realized that dosage of 30 mg twice daily is too high for our Indian patients. I have found that approximately 70% of my patients were able to tolerate only 30 mg once daily. The major side effect which I have encountered in patients while administering a dose of 30 mg twice daily is nausea, vomiting, diarrhea, headache, and hyperacidity. Some of my patients did not tolerate even the initial 10 mg once daily dose.
Learning from my experience, now, I have started stepping up the dose very slowly. I initiate the treatment with the starter pack, but with once daily dosage only. For patients who tolerate the once daily starter pack, I continue 30 mg once daily for a month before deciding to step up. I have found this method to be safe and effective.
In some patients, who do not tolerate even that dose, and are ready to give another try, I build up the dose steadily as 10 mg once daily for a month and then only increase to 20 and then 30 over 2 months.
However, more studies on the use of lower doses of apremilast for our population need to be done before we can conclude on its efficacy and safety.
The current recommended dosage schedule is shown in [Table 2].
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]