Efficacy of tacrolimus 0.1% ointment in cutaneous lupus erythematosus: a multicenter, randomized, double-blind, vehicle-controlled trial.

BACKGROUND: Topical calcineurin inhibitors are licensed for the treatment of atopic dermatitis; however, the efficacy of tacrolimus in cutaneous lupus erythematosus (CLE) has only been shown in single case reports. OBJECTIVE: In a multicenter, randomized, double-blind, vehicle-controlled trial, we sought to evaluate the efficacy of tacrolimus 0.1% ointment for skin lesions in CLE. METHODS: Thirty patients (18 female, 12 male) with different subtypes of CLE were included, and two selected skin lesions in each patient were treated either with tacrolimus 0.1% ointment or vehicle twice daily for 12 weeks. The evaluation included scoring of clinical features, such as erythema, hypertrophy/desquamation, edema, and dysesthesia. RESULTS: Significant improvement (P < .05) was seen in skin lesions of CLE patients treated with tacrolimus 0.1% ointment after 28 and 56 days, but not after 84 days, compared with skin lesions treated with vehicle. Edema responded most rapidly to tacrolimus 0.1% ointment and the effect was significant (P < .001) in comparison to treatment with vehicle after 28 days. Clinical score changes in erythema also showed remarkable improvement (P < .05) after 28 days, but not after 56 and 84 days. Moreover, patients with lupus erythematosus tumidus revealed the highest degree of improvement. None of the patients with CLE demonstrated any major side effects. LIMITATIONS: The study was limited by the small sample size. CONCLUSION: Explorative subgroup analyses revealed that topical application of tacrolimus 0.1% ointment may provide at least temporary benefit, especially in acute, edematous, non-hyperkeratotic lesions of CLE patients, suggesting that calcineurin inhibitors may represent an alternative treatment for the various disease subtypes.

Photoprotective effects of a broad-spectrum sunscreen in ultraviolet-induced cutaneous lupus erythematosus: a randomized, vehicle-controlled, double-blind study.

OBJECTIVE: We sought to assess if the exclusive use of a broad-spectrum sunscreen can prevent skin lesions in patients with different subtypes of cutaneous lupus erythematosus (CLE) induced by ultraviolet (UV) irradiation under standardized conditions. METHODS: A total of 25 patients with a medical history of photosensitive CLE were included in this monocentric, randomized, vehicle-controlled, double-blind, intraindividual study. The test product and its vehicle were applied 15 minutes before UVA and UVB irradiation of uninvolved skin areas on the upper aspect of the back in a random order, and standardized phototesting was performed daily for 3 consecutive days. RESULTS: Characteristic skin lesions were induced by UVA and UVB irradiation in 16 patients with CLE in the untreated area, and 14 patients showed a positive test result in the vehicle-treated area. In contrast, no eruptions compatible with CLE were observed in the sunscreen-treated area in any of the 25 patients. This resulted in significant differences (P < .001) between UV-irradiated sunscreen-treated versus vehicle-treated areas, and between UV-irradiated sunscreen-treated versus untreated areas. Furthermore, a significant difference (P < .05) was observed concerning the age of disease onset and the patient history of photosensitivity. Patients who were younger than 40 years at onset of CLE reported photosensitivity significantly more often than patients with a higher age of disease onset. None of the patients showed any adverse events from application of the test product or the vehicle. LIMITATIONS: Data resulting from standardized experimental phototesting might not be transferable to a clinical setting. CONCLUSION: These results indicate clearly that the use of a highly protective broad-spectrum sunscreen can prevent skin lesions in photosensitive patients with different subtypes of CLE.

Effect of bosentan on skin fibrosis in patients with systemic sclerosis: a prospective, open-label, non-comparative trial.

OBJECTIVES: To assess the effect of the ET-receptor antagonist bosentan on skin fibrosis and functionality in patients with SSc. METHODS: In this prospective, open-label, non-comparative trial, a total of 10 patients with SSc received 62.5 mg of bosentan twice daily for 4 weeks and then 125 mg twice daily for 20 weeks. The primary endpoint was skin thickening as measured by the modified Rodnan skin score (mRSS). Further assessments included 20 MHz ultrasound, examination of digital ulcers (DUs) and evaluation of hand function by examining patients' fist closure. Furthermore, patients with SSc used the UK SSc Functional Score (UKFS), the modified scleroderma HAQ (SHAQ) and its visual analogue scale (VAS) to rate their disability related to specific organ systems. RESULTS: The mean change from baseline mRSS (the primary endpoint) was 6.4 at Week 24 of bosentan treatment, which was statistically significant (P < 0.001). Patients with both diffuse and limited SSc exhibited a statistically significant mean difference in the mRSS. Moreover, there was a significant healing of DUs noted between baseline and at Week 24 of bosentan treatment (P < 0.001); however, the 20 MHz ultrasound and the fist closure evaluation revealed no significant differences. There were also no statistically significant changes between baseline and Week 24 in the UKFS, the modified SHAQ and its VAS. CONCLUSION: In addition to the well-known effect of bosentan in prevention of DUs, the results of this study demonstrate that bosentan may also be effective at reducing skin fibrosis in patients with SSc.