Patient‐reported outcomes of topical therapies in actinic keratosis: A systematic review

Grada, Ayman; Feldman, Steven R.; Bragazzi, Nicola Luigi; Damiani, Giovanni

doi:10.1111/dth.14833

Cited by 21 publications

(27 citation statements)

References 31 publications

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“…Real-world data investigating the underlying motivation of patients undergoing AK treatment also confirms that most patients decide for treatment to avoid the transition to invasive SCC and since AK are widely considered precancerous lesions 25 . To this end, it is surprising how little information on patient-reported outcmes and patient perspectives in AK treatment is yet available 26 . Despite this, the transformation risk is presumably low for single lesions as progression rates have been estimated to range between 0 and 0.075% per lesion-year 8 .…”

Section: Discussionmentioning

confidence: 99%

Spontaneous regression rates of actinic keratosis: a systematic review and pooled analysis of randomized controlled trials

Steeb

Petzold

Hornung

et al. 2022

Sci Rep

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Actinic keratosis (AK) are precancerous lesions of the skin which may progress to invasive squamous cell carcinoma. However, single lesions may also persist or even regress and heal spontaneously. Until now, evidence on the natural course of AK including spontaneous regression is limited. We aimed to synthesize regression rates of AK. We performed a systematic literature research in Medline, Embase, and CENTRAL for eligible trials until 3rd March 2020. Spontaneous regression rates were pooled using a random-effects model to calculate pooled proportions of participant-specific and lesion-specific complete clearance rates reported for the placebo arms of randomized controlled trials. Subgroup analyses were performed to dissect differences according to the type of placebo, immunocompetence of the participants, and localization of the lesions. Data from 38 records was included. The pooled participant-specific clearance rate was 8% (95% CI 6–10%, I2 = 71%) while the lesion-specific clearance rate was 23% (95% CI 16–31%, I2 = 97%). The highest participant- and lesion-specific clearance rates were achieved 12 weeks after the end of treatment (12% and 33%, respectively). Subgroup analysis revealed participant- as well as lesion-specific clearance rates of 0% for organ transplant recipients (OTR). We conclude that only a few participants achieve complete regression of their AK without any active treatment. Besides, the results underline that lesion clearance without active treatment is unlikely in OTR. Thus, early and consequent treatment of AK is recommended. Special attention should be paid when treating AK of OTR.

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Section: Discussionmentioning

confidence: 99%

Spontaneous regression rates of actinic keratosis: a systematic review and pooled analysis of randomized controlled trials

Steeb

Petzold

Hornung

et al. 2022

Sci Rep

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“…Topical therapies with simpler and shorter treatment regimens have higher patient satisfaction and better adherence and improve overall quality of life. 6 Tirbanibulin may be an effective medication to circumvent these issues because patients do not have to apply tirbanibulin for prolonged periods of time, and observed LSRs are mostly mild. 14 Tirbanibulin is currently approved for topical use only.…”

Section: Discussionmentioning

confidence: 99%

“…2,5 Ingenol mebutate has been discontinued in the European, Canadian, and US markets because of its association with increased risk of nonmelanoma skin cancer (NMSC). 6 Diclofenac gel, imiquimod, ingenol mebutate, and 5-fluorouracil have similar efficacies in treating AKs. 7 Whereas treatment of AKs is prefaced on destruction of underlying precancerous cells, preventive measures can be utilized and include topical retinoids, chemical peels, and photoprotection.…”

Section: Introductionmentioning

confidence: 99%

1% Tirbanibulin Ointment for the Treatment of Actinic Keratoses

Dao

Sahni

et al. 2021

Ann Pharmacother

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Objective Actinic keratoses (AKs) are cutaneous lesions that arise in sun-damaged skin. AKs may transform into squamous cell carcinoma in situ. Tirbanibulin 1% ointment is a new topical treatment for AKs, recently approved by the Food and Drug Administration. Data Sources The PubMed database was searched for articles published from 1960 to March 31, 2021, using the keywords tirbanibulin and Klisyri. Data Extraction Phase 2 and phase 3 clinical trials were reviewed. Data Synthesis In phase 2 clinical trials, 43% of patients treated with tirbanibulin experienced complete clearance by day 57 (43% [95% CI = 32, 54]). Across two phase 3 clinical trials (pooled data), complete (100%) clearance occurred in 49% of patients in tirbanibulin groups and in only 9% of the vehicle groups (difference, 41% points; 95% CI = 35 to 47; P < 0.001). Although no comparative studies are available, tirbanibulin is applied for a shorter duration (5 days) compared with diclofenac 3% gel, fluorouracil 5% cream, and imiquimod 3.75% cream. Adverse events were mild and included pruritus, application site pain, and local skin reactions. Systemic adverse events such as necrosis and angioedema, observed with other AK treatments such as fluorouracil and imiquimod, were not observed with tirbanibulin, thus giving tirbanibulin a favorable safety profile. Relevance to Patient Care and Clinical Practice Tirbanibulin effectively reduces AK burden and recurrence and has a favorable safety profile with mild adverse events. In comparison, imiquimod, 5-flourouracil, and diclofenac can result in necrosis, angioedema, and arthralgias. Conclusion With a favorable safety profile and short regimen, tirbanibulin is an efficacious treatment for clinicians to utilize in their treatment toolbox when treating AKs on the face and scalp.

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“…Yet, the surgical approach is destructive and is linked to various complications, such as scarring, persistent oedema and anaesthesia [13]. Conventional therapeutic approaches include topical chemo-or immunotherapy and radiation-based treatment, with the former being the less effective due to low patient adherence [14]. Topical application of fluorouracil FU, 5% imiquimod (5% IMI) and 3% diclofenac in 2.5% hyaluronic acid (DHA), 0.015% ingenol mebutate (IngMeb) and trichloroacetic acid (TCA), regarding topical regimens, photodynamic therapy (PDT) and CO 2 laser ablation (CO 2 L), with or without aminolevulinic acid (ALA), or methyl-aminolevulinic acid (MAL), cryosurgery (CRYO) and electrodessication (ELD,), regarding radiation-based and minimally invasive treatments, have been described [15].…”

Section: Introductionmentioning

confidence: 99%

Treatment Options and Post-Treatment Malignant Transformation Rate of Actinic Cheilitis: A Systematic Review

Bakirtzi

Papadimitriou

Andreadis

et al. 2021

Cancers

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Actinic cheilitis is a premalignant condition that may evolve to squamous cell carcinoma. A consensus on its management has not been established, and large clinical trials are lacking. We aimed to review the existing data regarding the treatment of actinic cheilitis with various modalities regarding safety, efficacy, recursions, and post-treatment malignant transformation. A systematic review was conducted through Pubmed, Ovid and the Cochrane library for studies in English language and the references of included papers from inception to January 2021. Case series were considered if ≥6 patients were included. Of the 698 articles, 36 studies and, overall, 699 patients were eventually reviewed. Laser ablation and vermilionectomy provided the best clinical and aesthetic outcomes with few recurrences, while photodynamic therapy was linked to more relapses. Generally, the adverse events were minor and there was no risk of post-treatment malignant transformation. The limitations of our review include the heterogeneity and the small number of patients across studies. Conclusively, invasive treatments demonstrated superior therapeutic and safety profile. Nevertheless, high-quality head-to-head studies that assess different modalities for actinic cheilitis and report patient preferences are lacking.

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Patient‐reported outcomes of topical therapies in actinic keratosis: A systematic review

Cited by 21 publications

References 31 publications

Spontaneous regression rates of actinic keratosis: a systematic review and pooled analysis of randomized controlled trials

Spontaneous regression rates of actinic keratosis: a systematic review and pooled analysis of randomized controlled trials

1% Tirbanibulin Ointment for the Treatment of Actinic Keratoses

Treatment Options and Post-Treatment Malignant Transformation Rate of Actinic Cheilitis: A Systematic Review

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