The addition of a 6-week course of narrow-band (NB) ultraviolet B (UVB) phototherapy to fumaric acid esters (FAEs) helps accelerate clinical response and improvement in quality of life in patients with moderate to severe plaque psoriasis, according to the results of a randomized prospective Austrian trial (ClinicalTrials.gov identifier: NCT01320164) published in the British Journal of Dermatology.
The investigators sought to evaluate the synergistic effect of 6 weeks of NB UVB phototherapy combined with FAEs in 30 adult patients with moderate to severe plaque psoriasis. Participants with a Psoriasis Area and Severity Index (PASI) of ≥10 and a body surface area of ≥10 were randomly assigned to treatment with either monotherapy containing FAEs (n=16) or combination therapy with FAEs plus NB UVB (n=14).
The primary study outcome was mean PASI reduction after 6 weeks of treatment. Secondary outcome measures included PASI 75 response (ie, ≥75% improvement in PASI from baseline), Psoriasis Log-based Area and Severity Index (PLASI), and Dermatology Life Quality Index (DLQI).
Of the 30 participants, 19 were men; mean patient age was 52. Mean absolute and relative reduction in PASI after 6 weeks of treatment was significantly greater in the combination therapy group (10.1% and 68.9%, respectively) compared with the FAE monotherapy group (4.8% and 36.5%, respectively; P =.016). At the conclusion of the study, median PASI scores were 2.9 in the combination group and 2.4 in the monotherapy group.
After 6 weeks of treatment, mean absolute and relative reduction in PLASI was significantly greater with combination therapy (17.5% and 65.4%, respectively) compared with FAE monotherapy (8.8% and 36.1%, respectively; P =.016). PLASI 75 was achieved by 78.6% (11 of 14) of patients in the combination group but none of the participants in the monotherapy group.
A faster improvement in DLQI was reported in patients in the combination treatment group compared with patients in the FAE-alone group. Mean absolute and relative DLQI reduction after 8 weeks of treatment was significantly greater with combination therapy (8.9% and 73.2%, respectively) vs FAE monotherapy (8.0% and 55.4%, respectively; P =.031).
Adverse effects associated with FAE use were reported in 75% (12 of 16) of patients in the monotherapy group vs 21% (3 of 14) in the combination therapy group. Most of the adverse effects were gastrointestinal complaints.
The investigators concluded that significant improvements in short-term clinical outcomes reported with combination therapy in patients with plaque psoriasis might be due, in part, to their regular contact with healthcare providers while undergoing phototherapy. This might also have an impact on adherence to FAE therapy in real-life settings.
Tzaneva S, Geroldinger A, Trattner H, Tanew A. Fumaric acid esters in combination with a 6-week course of narrow-band UVB provides for an accelerated response as compared to fumaric acid esters monotherapy in patients with moderate to severe plaque psoriasis: a randomized prospective clinical study [published online November 8, 2017]. Br J Dermatol. doi:10.1111/bjd.16106