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

Large Variability of Frequency and Type of Physical Therapy in Patients in the German Network for Systemic Sclerosis

Objective To determine the type and frequency of physical therapy (PT) prescribed by physicians for patients in the registry of the German Network for Systemic Sclerosis. Methods The data for 4,252 patients were analyzed using descriptive statistics, chi-square tests, and odds ratios (ORs). Results Overall, 37.4% of patients (1,590 of 4,252) receivedPTat the end of a yearly follow-up. The most frequently used type ofPTwas lymphatic drainage (n = 1,061, 36.8%), followed by exercise therapy (n = 1,047, 36.3%) and heat therapy (n = 689, 23.9%). More than three-fourths of treated patients (82%) received 1 or 2 different forms ofPTsimultaneously. The prescription ofPTwas associated with the extent of skin fibrosis as measured by the modified Rodnan skin thickness score (21 [63.9% of patients];P< 0.001). Patients with musculoskeletal involvement (e.g., arthritis, muscle weakness, joint contractures, tendon friction rubs) had a higher chance of receivingPTthan patients without these symptoms, with correspondingORs ranging from 1.96 (95% confidence interval [95%CI] 1.69-2.28) for joint contractures to 3.83 (95%CI2.89-5.08) for arthritis. When comparing the type ofPTprescription across the initial and all follow-up visits from 2003 to 2017, significant alterations with a decreasing frequency of patients receivingPTcould be observed (P= 0.001). Conclusion To our knowledge, this is the first study reporting the use ofPTin patients with systemic sclerosis (SSc) in a large cohort. AlthoughSSc is characterized by considerable disability and restriction of motion, PT