Galderma: New Data Reveals Benefits of Combining Oral and Topical Treatment in Patients With Severe Papulopustular Rosacea

LAUSANNE,Switzerland,March 1,2019 -- First randomized clinical trial comparing the efficacy andsafety of combined doxycycline 40 mg modified release (DMR) and ivermectin 1% cream (IVM), versus ivermectin 1% cream plus placebo in adults with severe papulopustular rosacea,reveals more than double the number of patients reach 'clear' (100% lesion clearance) at 12 weeks

Today,Galderma shares the results of its ANSWER study,which highlights a superior reduction of inflammatory lesions with combination doxycycline 40 mg modified release capsules (DMR) and ivermectin 1% cream (IVM),compared to IVM plus placebo,in adults with severe papulopustular rosacea (IGA 4*) at 12 weeks.

Clinicians often use a combination of topical and oral therapies for the treatment of rosacea. A previous study confirmed the increased benefits of combination therapy.[1] More recently,once daily IVM has been shown to be more effective than twice daily metronidazole 0.75%.[2] The ANSWER study is the first to evaluate the combination of IVM and DMR,which is the only approved oral treatment for inflammatory rosacea lesions.[3]

According to the results,the combination treatment was associated with 2.5 times more patients achieving 100% lesion clearance already at 12 weeks compared with IVM plus placebo (17.8% vs. 7.2%). DMR and IVM also worked significantly faster than IVM plus placebo,with significant differences seen as early as week 4. The safety profile of both treatment arms was generally well tolerated with no significant differences between the arms. The data is revealed as a poster at the 2019 American Academy of Dermatology (AAD) Annual Meeting in Washington,D.C.,USA.[4]

"ANSWER is a significant step forward for people suffering with severe rosacea,and for clinicians in this field. The data shows combination therapy with IVM + DMR was a safe and more efficacious option with a faster onset of action compared to IVM alone," says Dr James Del Rosso,DO of JDR Dermatology Research/Thomas Dermatology,Las Vegas,Nevada,who is presenting the data at AAD.

"Reaching clear is a tremendous achievement for those living with this chronic,visible disease.Through combination (DMR + IVM) treatment more people willhave the opportunity to reach clear and be relieved of the physical,emotional and psychological burden of this disease."

Results showed a consistent outcome in doubling the number of patients achieving 'clear' (IGA 0) which is defined as 100% clearance in inflammatory lesions and erythema (redness) at 12 weeks using combination therapy (11.9% vs 5.1%) in this severe population.

In addition,three quarters of patients in both treatment groups saw a reduction in burning and stinging sensations by week 12,with 73.3% and 75.4% of patients reporting complete elimination of these symptoms on combination therapy and monotherapy,respectively. Both treatment arms also experienced a substantial increase in the proportion of patients without flushing episodes (-47.2% IVM+DMR vs -41.9% IVM+PBO) and a significant improvement in DLQI** (quality of life).

"The ANSWER results demonstrate the optimized clinical outcome of associating these two treatmentsin patients with severerosacea,both known for theirefficacy and safety profile.Ivermectin again showed efficacy and the combination with modified release doxycycline has significantly increased the number of patients achieving 100% lesion reduction,without compromising the safety profile" says Kamel Chaouche,Head of Global Medical Affairs Rx SIG,Galderma Nestle Skin Health.

"Galderma has a long-standing commitment to skin health and we know that the impact dermatological conditions have on people is more than skin-deep,regardless of severity. ANSWERprovides us with important new evidencewhich supports our mission to help patients with rosacea to reach clear."

* The success of rosacea treatment is usually defined as a score of 1 ('almost clear') or 0 ('clear') on the 5-point Investigator Global Assessment (IGA) scale. Several studies have shown that patients who achieve 'clear' (IGA 0),a complete reduction in symptoms,experience an extended time to relapse and an improved quality of life compared with patients who are 'almost clear' (IGA 1)[5]

** DLQI is the most well-known quality-of-life index in dermatology[6]

References:

Schaller M,et al. Br J Dermatol 2017;176:465-471

Taieb A,et al. Br J Dermatol 2015;172:1103-1110

Oracea® SmPC: https://www.ema.europa.eu/en/medicines/human/referrals/oracea

Del Rosso J et al. Combined doxycycline 40 mg modified release capsules plus ivermectin 1% cream therapy for severe rosacea. 3 March 2019. Poster presented at 2019 AAD Annual Meeting,Washington,USA. Poster 10628

Webster G et al. J Dermatolog Treat. 2017;28(5):469-474

Shikiar R,et al. Health and Quality of Life Outcomes 2005;3:36

About Rosacea

Rosacea is a common inflammatory skin disease that presents variable clinical characteristics,of which the most common are flushing,permanent erythema,and inflammatory lesions. It mainly affects the central areas of the face,such as the cheeks and nose. The disease can affect both adult men and women,usually after the age of 30. Additionally,symptoms such as stinging,burning and increased sensitivity of the skin are common. The eyes are often affected,and might present as red,dry or itchy.

Although the cause of the disease is still under debate,various trigger factors are known,including spicy foods,alcohol,emotional stress,sun/UV-exposure,hot baths and beverages. Demodex,generally harmless mites,can also be found in the skin in an elevated quantity in people with rosacea.

Rosacea may worsen over time if left untreated. People that suspect they suffer from rosacea should visit their dermatologist or healthcare provider for diagnosis and discuss what treatment is right for them. Because rosacea is a highly visible disease,it is known to cause embarrassment and anxiety in some patients,which in turn may cause frustration and have a negative impact on their social life.

About ANSWER

ANSWER is a multicenter (US,EU,CAN),randomized,vehicle-controlled,investigator-blinded,parallel-group,comparison study treating patients with severe rosacea (IGA 4) with concomitant use of topical ivermectin 1% cream (IVM) and doxycycline 40 mg modified-release (DMR) capsules. The aim of the study was to evaluate if IVM + DMR association is more efficient than IVM + placebo alone. Patients received either IVM + DMR (n= 135) or IVM + placebo once daily for 12 weeks (n= 138). Subjects were ≥18 years,with >20 to max. 70 inflammatory lesions (papules and pustules) on the face.

About Galderma

Galderma,Nestle Skin Health's medical solutions business,was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information,please visit http://www.galderma.com

Galderma media relations contact

Sebastien Cros

Global Communications

+41-21-642-76-94

media@galderma.com