Apremilast and Narrowband Ultraviolet-B Combination Therapy for Treating Moderate-to-Severe Plaque Psoriasis
October 2017 | Volume 16 | Issue 10 | Original Article | 957 | Copyright © October 2017
Jerry Bagel MD MS, Elise Nelson LPN, Brian R. Keegan MD PhD
Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ
BACKGROUND: Combining narrowband UVB (NB-UVB) phototherapy with biologics has been shown to enhance the therapeutic response of plaque psoriasis patients. The objective of this study was to evaluate the effectiveness of apremilast combined with NB-UVB in patients with moderate to severe plaque psoriasis.
METHODS: This was a 12-week, open-label study of 29 patients diagnosed with moderate to severe psoriasis. Patients received apremilast 30 mg twice daily, and increasing doses of NB-UVB (310-312 nm) 3 times per week for 12 weeks.
RESULTS: Twenty-two of 29 patients (76%) completed the 12-week apremilast and NB-UVB combination therapy; 73% (16 of 22 completers) achieved a PASI 75 response at week 12. Mean scores for PASI, VAS pain, VAS itch, DLQI, and PGA improved by 77%, 77%, 69%, 70%, and 67%, respectively, at week 12. The most commonly reported adverse events (AEs) were mild and moderate first-degree burns related to NB-UVB (n=11 [38%] patients). A second-degree NB-UVB burn was reported (likely due to an underlying photosensitivity) and was considered a serious AE.
CONCLUSION: The combination of apremilast with NB-UVB was effective for the treatment of moderate to severe plaque psoriasis, without any unexpected safety signals. Apremilast combined with NB-UVB provided a high treatment response in patients with moderate to severe plaque psoriasis, and may be an option for patients to enhance a patientâ€™s initial therapeutic response.
J Drugs Dermatol. 2017;16(10):957-962.
Approximately 1.5% to 3% of the populations in the United States and Europe have been estimated to have psoriasis.1,2 Those with plaque psoriasis have a high incidence of certain comorbidities,3,4 including coronary artery disease,5 atherosclerosis,6 metabolic syndrome,7-9 and diabetes.10 Plaque psoriasis also reduces quality of life,4 is a significant disability burden,11 and is associated with higher healthcare utilization and costs.3 Monotherapies such as phototherapy, conventional systemic agents, and newer biologics are commonly used to treat plaque psoriasis; however, single therapies do not always adequately control patients’ symptoms.12 Rather than increasing the dosage of monotherapies, which may be limited due to concerns of accumulating toxicity, combination therapy is often employed to improve overall treatment response and minimize adverse effects.12 Studies in those with plaque psoriasis have shown that incorporating narrowband UVB phototherapy (NB-UVB) with a biologic could improve patients’ disease,13-18 could be more efficacious than a biologic alone,16,18-21 could restore an initial therapeutic response with a biologic that had waned,19,22,23 or could accelerate the therapeutic response of a biologic.16,18,20,21 Apremilast is a small-molecule, phosphodiesterase 4 inhibitor given orally,24 rather than by injection as biologics are given. Two large, phase 3 studies have demonstrated efficacy, a good safety profile, and improved health-related quality of life with apremilast in patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.25-27 In a retrospective chart review (n=81), 81% of plaque psoriasis patients who completed 12 weeks of apremilast with photo-, systemic or biologic therapy achieved a psoriasis area severity index (PASI) of 75 after 12 weeks, with 8 of the 9 patients (89%) who completed apremilast and NB-UVB therapy achieving that response.28 To date, the addition of NB-UVB to apremilast has not been formally evaluated. Thus, this pilot study examined the effectiveness and safety of apremilast in combination with NB-UVB for 12 weeks in patients with moderate to severe plaque psoriasis to determine if NB-UVB could enhance the efficacy of apremilast. The proportion of patients who achieved PASI 75 after 12 weeks of treatment with apremilast plus NB-UVB was evaluated.
Study Design and Treatment
This was a single-center, 12-week, open-label, pilot study designed to evaluate the effectiveness and safety of apremilast (Otezla®, Celgene Corporation, Summit, NJ) combined with NB-UVB for the treatment of moderate to severe plaque psoriasis. The study protocol and informed consent were approved by an institutional review board and the study was conducted in