Article Published In JAMA Dermatology Shows Long-Term Effectiveness Of Ingenol Mebutate In Treating Actinic Keratosis

Date: Mar-22-2013Two-three day treatment provides clinically relevant, sustained clearance of AK after
12 months

An analysis of long-term clearance rates of actinic keratosis (AK) lesions after
treatment with ingenol mebutate (Picato(R)) gel is today published in the Journal of the
American Medical Association (JAMA) Dermatology,[1] formerly known as the Archives of
Dermatology.

Previously, the pooled results of the four phase III trials of ingenol mebutate
published in the New England Journal of Medicine (NEJM) showed that ingenol mebutate gel
effectively clears AK lesions after a two or three day topical treatment of an area of
skin (also known as a field).[2]

The current data in JAMA Dermatology show that patients who achieved complete
clearance after initial treatment with ingenol mebutate gel, also experience sustained
clearance of AK lesions one year later.[1]

The primary outcome of the study showed that patients showing sustained complete
clearance at 12 months, was 46% on the face and scalp and 44% on the trunk or extremities.
The secondary outcome showed that patients in the overall population experienced
approximately 87% reduction in the original number of actinic keratoses in the treated
area of skin.[1]

The authors of the article 'Long-Term Follow-up of Ingenol Mebutate Gel for the
Treatment of Actinic Keratosis' concluded:

"Ingenol mebutate gel applied as field therapy for only two or three consecutive daily
doses was effective when treating head or body actinic keratoses, producing clinically
relevant sustained clearance and long-term reduction in lesions."[1]

Author Dr Stephen Shumack, a Consultant Dermatologist from Sydney's Royal North Shore
Hospital, Australia, commented:

"These long-term data are encouraging for patients with actinic keratosis. It has now
been demonstrated that once daily, two or three day treatment with ingenol mebutate gel
leads to a reduction in the number of actinic keratoses present after 12 months, compared
to the number seen at baseline. These results are comparable to those seen with other
topical therapies with longer treatment durations.[1]These data show long-term
effectiveness combined with short duration of treatment, offering a significant benefit to
patients living with actinic keratosis."

Dr Kim Kjoller, Senior Vice President of Global Development at LEO, said:

"These data provide clear evidence that ingenol mebutate gel is effective in
sustaining long-term clearance of actinic keratoses. The short duration of treatment
required for ingenol mebutate is an important step in providing convenient and effective
solutions to treat this widespread condition."

Actinic keratoses are rough skin lesions caused by cumulative exposure to the sun,
which can potentially lead to non-melanoma skin cancer (NMSC) if not treated early and
effectively.[3] The majority of lesions are caused by long-term sun exposure in
fair-skinned people. The number of patients with actinic keratosis is rapidly growing,
especially in Europe, the US and Australia.[4]

Ingenol mebutate gel is available in two different concentrations. For treatment of
the face and scalp, ingenol mebutate gel is applied at a concentration of 150 mcg/g over a
25 cm[2] area once daily for three consecutive days. For treatment of the body, ingenol
mebutate gel is applied over a 25 cm[2] area once daily for two consecutive days at a
concentration of 500 mcg/g.

Ingenol mebutate gel was approved by the US Food and Drug Administration (FDA) in
January 2012; by the Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil in July
2012; and by the Therapeutic Goods Administration (TGA) in Australia, the European
Commission (EC) in Europe in November 2012 and by Health Canada in January 2013.

About Picato(R) gel

Picato(R) gel is a topical, field-directed therapy which is self-administered by the
patient to the affected areas of the skin once a day for two or three consecutive days,
depending on the treatment area.

Picato(R) gel has two strengths and two application regimens to follow, dependent upon
the location of the actinic keratoses. Picato(R) gel is applied over a 25cm[2] treatment
area for two consecutive days when treating actinic keratoses on the trunk and extremities
(500 mcg/g) and over three consecutive days for the face and scalp (150mcg/g).

Picato(R) gel has been shown in a large clinical trial programme to effectively clear
actinic keratosis lesions on the face and scalp, as well as on the trunk and
extremities.[2]

The mechanism of action (MoA) for Picato(R) gel is not fully understood. In vivo and
in vitro data suggest a dual MoA, including direct lesional cell death and infiltration of
immunocompetent cells.[5],[6]

Non-invasive examination of skin treated with Picato(R) gel showed an almost complete
resolution of induced skin changes measured at two months post treatment, and patients
treated with Picato(R) gel showed a higher treatment satisfaction than placebo-treated
patients in clinical trials.[2]
Please see full prescribing information available here.

About actinic keratosis (AK)

Actinic keratoses are skin lesions, which are often red, scaly and may initially be
mistaken for a rash or other skin irritation. The majority of lesions are caused by sun
exposure in fair-skinned people.

The number of patients with actinic keratosis is rapidly growing, especially in
Europe, the US and Australia.[4]

Actinic keratoses are more common in males, and individuals with a fair skin type.
Additional risk factors include advanced age and immunodeficiency. Immunocompromised
patients have a 65 to 250 fold higher risk for actinic keratoses and invasive squamous
cell carcinoma, which is a type of NMSC.[7]

Actinic keratosis is a precursor to non-melanoma skin cancer which is the second most
common type of skin cancer. [8],[9]

After receiving a diagnosis of actinic keratosis, the risk of developing squamous cell
carcinoma over a ten year period is approximately ten per cent for a patient having an
average of 7.7 actinic keratosis lesions,[8],[10],[11] and it is impossible to predict
which lesions will develop into skin cancer.[12]

A study has shown that around between 40-80 per cent of squamous cell carcinoma cases
may begin as actinic keratoses,[8],[13],[14] and patients with the condition are six times
more likely to develop any type of skin cancer than people without it.[15]

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.