Long-term clinical outcomes of imiquimod 5% cream vs. diclofenac 3% gel for actinic keratosis on the face or scalp: a pooled analysis of two randomized controlled trials
| Autor: | R Kunstfeld, Harald Gollnick, R Ostendorf, Helmut Kerl, Thomas Dirschka |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Male medicine.medical_specialty Diclofenac Keratosis Skin Cream Actinic keratosis (AK) Imiquimod Dermatology Gastroenterology law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Adjuvants Immunologic law Internal medicine medicine Carcinoma Clinical endpoint Humans 610.72 Aged Scalp business.industry Actinic keratosis Anti-Inflammatory Agents Non-Steroidal Middle Aged medicine.disease Keratosis Actinic 030104 developmental biology Infectious Diseases medicine.anatomical_structure diclofenac 3% gel Carcinoma Squamous Cell Female Imiquimod 5% cream Facial Neoplasms business Gels medicine.drug |
| Zdroj: | Journal of the European Academy of Dermatology and Venereology : JEADVReferences. 34(1) |
| ISSN: | 1468-3083 |
| Popis: | Background Actinic keratosis (AK) is an early in situ epidermal cancer which can progress to invasive squamous cell carcinoma (SCC). Imiquimod 5% cream (IMIQ) and diclofenac 3% gel (DIC) are frequently used to treat AK; however, their long-term effects following repeated treatment cycles have never been compared. Objective To compare IMIQ and DIC in the treatment of AK with respect to the risk of change to grade III AK or invasive SCC, after 3 years. Methods Data were pooled from two randomized, active-controlled, open-label, multicentre, multinational, phase IV studies (Clinicaltrials.gov NCT00777127/NCT01453179), with two parallel groups. Studies were conducted between 2008 and 2015 and were almost identical in design. Patients eligible for inclusion were immunocompetent adults with 5-10 visible AK lesions on the face/scalp and grade I/II AK. The primary endpoint was inhibition of histological change to grade III AK or invasive SCC in the study treatment area, observed until month 36. Patients applied either IMIQ or DIC for a maximum of six treatment cycles. Results In total, 479 patients (IMIQ 242; DIC 237) were included in the full analysis set. Histological change to grade III AK or invasive SCC was observed until month 36 in 13 (5.4%) patients treated with IMIQ, compared with 26 (11.0%) patients treated with DIC (absolute risk difference -5.6% [95% confidence interval -10.7%, -0.7%]). Time to histological change was greater in the IMIQ group than the DIC group (P = 0.0266). Frequency of progression to invasive SCC was lower with IMIQ than with DIC at all time points. Initial clearance rate was higher in the IMIQ group compared with the DIC group, while recurrence rate was lower. Both treatments were well tolerated. Conclusions Over 3 years, IMIQ was superior to DIC in clearing AK lesions and preventing histological change to grade III AK or invasive SCC and recurrence. |
| Databáze: | OpenAIRE |
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