Ingenol mebutate as topical treatment for actinic keratosis based on a prospective, non-interventional, multicentre study of real-life clinical practice in Germany: efficacy and quality of life.

BACKGROUND: The use of ingenol mebutate (IM) as a field-directed therapy over a short period of time has been shown to be effective and well tolerated in randomized Phase III trials. OBJECTIVES: To assess the efficacy and patient-reported outcomes for IM as treatment for actinic keratosis (AK) under daily "real-life" practice conditions. MATERIALS AND METHODS: A total of 826 adult patients with AK were enrolled by 292 dermatologists in Germany in a prospective, open, non-interventional, non-controlled, multicentre study. All patients were treated with IM and followed for eight weeks. RESULTS: The mean number of clinically visible AK lesions decreased significantly from 7.1±6.8 to 2.8±4.5 (p<0.0001). Most dermatologists (79.0%) rated global efficacy of IM as "very good"/"good" and 82.6% of the patients were "very satisfied" or "rather satisfied" with the efficacy of IM. Patient-reported outcomes showed greater efficacy and treatment comfort with IM compared to any last previous AK treatment with a comparable tolerability profile. Skin-related QoL data revealed a significant improvement of 50.2% after IM treatment (p<0.0001). Adverse events were reported in 7.0% of all patients, which were in most cases mild in intensity. CONCLUSION: Field-directed treatment with IM over a short period was associated with a high level of treatment satisfaction, as reported by dermatologists and patients. This observational study demonstrates the effectiveness and tolerability of IM in everyday clinical practice in addition to the known efficacy and safety obtained by randomized controlled clinical trials.

Practicability of combined treatment with calcipotriol/betamethasone gel (Daivobet® Gel) and improvement of quality of life in patients with psoriasis.

BACKGROUND: The successful treatment of psoriasis depends not only on the efficacy of the medication but also on patientsí acceptance and adherence to the prescribed regimen. PATIENTS AND METHODS: In this non-interventional, prospective trial 579 patients with psoriasis were treated once daily with the fixed combination of calcipotriol 50 µg/g plus betamethasone 0.5 mg/g (Daivobet® Gel) for 4 weeks. Comparing the new medication to their previous treatment, patients assessed their quality of life by means of the Dermatology Life Quality Index (DLQI), reported their therapy- associated burden in daily life by the Psoriasis Disability Index (PDI) and assessed how easy the new medication was to employ. Disease severity was rated at the start and end of the study by physicians and patients using a Global Assessment (PGA from 0-5 points) and the Body Surface Area (BSA) assessed by the physicians. RESULTS: Quality of life improved from 8.7 to 3.2 points (p < 0.0001) parallel to a significant decrease of PGA by 39.6% (p < 0.0001) and BSA (72.5% of patients with BSA > 4% before vs. 37.3% after therapy). The application of the study medication was 30% less time-consuming and handling associated with significantly higher patient satisfaction. Efficacy and tolerability of Daivobet® Gel versus prior treatment were judged "very good" in 85.7% vs. 27.6% of patients. CONCLUSIONS: The study substantiates a significant improvement of the quality of life during therapy with the fixed combination. Patients benefit from the convenience and time-saving as compared to their prior treatment. Thus, Daivobet® Gel can be recommended as an effective and well-tolerated treatment which may easily be integrated into daily life of patients with psoriasis.

Effective treatment and improvement of quality of life in patients with scalp psoriasis by topical use of calcipotriol/betamethasone (Xamiol®-gel): results.

BACKGROUND: Quality of life of patients with scalp psoriasis is greatly impaired due to itch and scaling. To control the disease long-term therapy is necessary and treatment success is greatly dependent on compliance. PATIENTS AND METHODS: In a prospective, non-interventional trial in German dermatological practices 721 patients with scalp psoriasis received Xamiol(®) gel (calcipotriol 50 µg/g, betamethasone 0,5 mg/g) topically for 4 weeks. Severity was assessed by physician's global assessment (PGA) and quality of life by using a scalp-specific questionnaire at the beginning of the study and after 4 weeks of treatment. RESULTS: The mean disease severity of scalp psoriasis (PGA) improved from 4.26 to 2.49 (-41.8 %, p < 0.0001) during 4 weeks of treatment and quality of life improved from 10.57 to 3.22 (-69.5 %, p < 0.0001). Among patients with pre-treatment 89.5 % of patients and 87.9 % of dermatologists judged treatment response to Xamiol(®) gel as better/much better compared to previous therapy. Tolerability of Xamiol(®) gel was rated good/very good by 98 % of dermatologists and patients, respectively. The use of Xamiol(®) gel was found easy/very easy by 90.4 % of the patients. CONCLUSIONS: Due to the major improvement of quality of life and quick onset of improvement together with the high acceptance by the patients Xamiol(®) gel may be regarded as the topical treatment of choice for scalp psoriasis.