Pharmaceutical Market Europe • November 2024 • 10-11

DERMATOLOGY NEWS

LEO shares Adbry final results for atopic dermatitis

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LEO Pharma has shared final results from a long-term extension study of its atopic dermatitis (AD) drug Adbry (tralokinumab-ldrm) in adults and adolescents aged 12 years and older with moderate-to-severe cases of the condition.

The phase 3 ECZTEND study evaluated Adbry, marketed for AD outside the US under the brand name Adtralza, for up to five years in patients who completed their treatment with the drug in one of nine parent trials.

The data presented at this year’s Fall Clinical Dermatology Conference showed that Adbry demonstrated sustained efficacy after up to one year in the parent trials plus up to five years in ECZTEND.

A reduction of at least 75% in Eczema Area and Severity Index from baseline to week 248 was observed in 92.9% of patients, and 66.7% achieved an Investigator’s Global Assessment score of clear or almost clear in the same period. Improvements in itch, sleep and quality of life were also observed.

No new safety signals were identified and the overall long-term safety profile was similar to that observed in the initial placebo-controlled treatment period of the parent trials.


Dermavant reports Vtama long-term results for atopic dermatitis

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Dermavant Sciences has announced promising long-term results for its plaque psoriasis-approved Vtama (tapinarof) cream in adults and children as young as two years with atopic dermatitis (AD).

The ADORING 3 48-week long-term extension study enrolled eligible patients from the identical phase 3 ADORING 1 and 2 trials, as well as a four-week maximal usage pharmacokinetics study, and Vtama cream-naïve patients aged two to 17 years with mild, moderate or severe AD who did not meet inclusion in ADORING 1 and 2.

Final data presented at the Annual Fall Clinical Dermatology Conference showed that 51.9% of patients entered with or achieved complete disease clearance at least once during the 48-week study, while 81.6% entered with or achieved clear or almost clear skin at least once.

After entering ADORING 3 with or first achieving complete disease clearance and discontinuing Vtama cream, 1%, the average duration of the first treatment-free interval was 79.8 consecutive days, and patients whose disease returned to mild or above off-treatment gained complete clearance when re-treated.

There was also no evidence of loss of response in patients receiving continuous or intermittent Vtama.


Ipsen’s Kayfanda approved by EC for cholestatic pruritus in ALGS

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Ipsen’s Kayfanda (odevixibat) has been approved by the European Commission (EC) under exceptional circumstances to treat cholestatic pruritus in Alagille syndrome (ALGS) patients aged six months and older.

Occurring in approximately three in every 100,000 births globally, ALGS is a rare genetic disorder that can affect multiple organ systems in the body, including the liver, heart, skeleton, eyes and kidneys.

Symptoms usually develop during the first three months of life and include severe itching (pruritis), yellowing of the skin and mucous membranes (jaundice), and blockage of the flow of bile from the liver (cholestasis).

Kayfanda is an oral, non-systemic bile acid transport inhibitor that Ipsen gained access to after it acquired rare disease specialist Albireo last year for $952m.

The EC’s decision was supported by positive results from the late-stage ASSERT trial, which demonstrated statistically significant and clinically meaningful improvements from baseline to six months in scratching severity for patients receiving Kayfanda versus those randomised to receive placebo.

A statistically significant reduction in serum bile acid concentration at the end of treatment was also demonstrated for patients on Kayfanda versus placebo.


BMS announces positive data for Sotyktu in psoriasis

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Bristol Myers Squibb (BMS) has announced positive results from a phase 3b/4 study of its oral TYK2 inhibitor Sotyktu (deucravacitinib) in moderate-to-severe scalp psoriasis.

Data from the ongoing PSORIATYK SCALP trial, which included patients with less extensive overall psoriasis, was presented at this year’s European Academy of Dermatology and Venereology Congress.

At least 100 million people worldwide are affected by psoriasis, an immune-mediated disease that causes inflammation in the body. Scalp psoriasis occurs in approximately 80% of patients with plaque psoriasis, the most common form of the condition, and is associated with itching, flaking, pain and bleeding.

The primary endpoint of PSORIATYK SCALP was met, with more than three times as many patients achieving a scalp-specific Physician’s Global Assessment response of zero or one (clear/almost clear) at week 16 compared to those on placebo, at 48.5% versus 13.7%, respectively.

Key secondary endpoints were also met at week 16, with a significantly higher percentage of patients achieving at least a 90% improvement in Psoriasis Scalp Severity Index response and a change from baseline in scalp-specific itch with Sotyktu treatment compared with placebo.


J&J’s Tremfya shows promise in ‘special site’ plaque psoriasis

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Johnson & Johnson (J&J) has presented positive results from a late-stage study of its dual-acting IL-23 inhibitor Tremfya (guselkumab) in plaque psoriasis patients.

The phase 3b SPECTREM trial has been evaluating the drug in adults with low body surface area moderate plaque psoriasis with special site (sensitive or highly visible areas) involvement who had failed topical treatment.

Data presented at this year’s Fall Clinical Dermatology Conference showed that a significantly greater proportion of patients who received Tremfya in SPECTREM achieved the primary endpoint of an Investigator’s Global Assessment (IGA) score of zero or one (clear/almost clear skin) compared to those who received placebo, at 74.2% versus 12.4%.

In scalp, facial, intertriginous and genital areas, IGA scores of zero or one were achieved by 75%, 87.8%, 86.5% and 78% of Tremfya-treated patients, and complete clearance of each special site was consistently achieved in the majority of patients who received Tremfya versus placebo.

Statistically significant improvements were also achieved across all major secondary endpoints, with 52.9% of Tremfya-treated patients achieving a Psoriasis Area Severity Index of 90 compared to 6.2% of those who received placebo.


Eli Lilly and Almirall share Ebglyss results for atopic dermatitis

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Eli Lilly and Almirall have shared long-term data for their targeted IL-13 inhibitor Ebglyss (lebrikizumab-lbkz) in moderate-to-severe atopic dermatitis (AD).

The ADjoin long-term extension study has been evaluating two dosing schedules of the drug in patients who completed 52 weeks in the phase 3 ADvocate 1 or 2 trials.

Typically referred to as eczema, AD is an inflammatory condition that causes the skin to become itchy, dry and cracked. It occurs in approximately 7.3% of adults in the US, and of those affected, about 40% have moderate or severe symptoms.

Results, presented at this year’s European Academy of Dermatology and Venereology Congress, showed that 84% of patients receiving Ebglyss once monthly and 83% of those receiving the drug every two weeks maintained clear or almost-clear skin at three years.

Additionally, 87% of patients in the once-monthly Ebglyss cohort and 79% of those receiving the drug every two weeks achieved or maintained at least a 90% improvement in disease extent and severity at three years, while 83% and 91% of patients in the respective dosing groups did not require either high-potency topical corticosteroids or systemic treatments.