New medicine for psoriasis!

News on April 26, 2021 // --Amgen recently announced a placebo-controlled oral anti-inflammatory drug Otezla (apremilast) in the treatment of mild to moderate plaque psoriasis at the 2021 American Academy of Dermatology Virtual Conference Experience (AAD VMX) Positive result of Phase 3 ADVANCE test .
The data showed that compared with placebo, Otezla significantly improved the severity of the disease, regardless of the patient's body surface area (BSA) affected by the disease .

In February 2021, based on ADVANCE research data, Amgen submitted a Supplemental New Drug Application (sNDA) to the US FDA to use Otezla for the treatment of mild to moderate plaque psoriasis eligible for phototherapy or systemic therapy Adult patients
.

Otezla is an oral anti-inflammatory drug of Celgene, which was acquired by Amgen for US$13.
4 billion in August 2019
.
In January 2019, Bristol-Myers Squibb (BMS) acquired Xinji for US$74 billion .
As part of the US Federal Trade Commission (FTC) antitrust review , Otezla was forced to sell, and Amgen later took over
.

Otezla is an oral selective phosphodiesterase 4 (PDE4) small molecule inhibitor.
It has been approved for 3 indications (moderate to severe plaque psoriasis, active psoriatic arthritis, Behcet’s disease-related oral ulcers) )
.
At the time of the acquisition, Otezla was the only oral, non-biological therapy for psoriasis and psoriatic arthritis, and the only drug for the treatment of Behcet's disease-related oral ulcers
.
According to the 2020 performance report released by Amgen, Otezla has sales of US$2.
195 billion, making it Amgen's third best-selling drug
.

Linda Stein Gold, MD, the lead researcher of the ADVANCE study and the Director of Clinical Research for Dermatology at Henry Ford Health System in Detroit, said: “Many patients with mild to moderate plaque psoriasis still report that despite the current available topical Treatment options, but they still face challenges in controlling the symptoms of the disease, which may have a significant impact on their daily lives.

ADVANCE study results show that oral Otezla significantly improved clinical indicators of disease severity, such as body surface area and scalp involvement
.
"

David M.
Reese, MD, Executive Vice President of Amgen Research and Development, said: "The positive results of the ADVANCE study add more and more evidence to support the potential benefits of Otezla for patients with mild to moderate plaque psoriasis
.
We look forward to it.
We continue to cooperate with the FDA to expand the application of oral Otezla to adult patients with mild to moderate disease
.
"

Mild to moderate plaque psoriasis (picture source: dermatologyadvisor.
com)

ADVANCE (PSOR-022, NCT03721172) is a multicenter, randomized, placebo-controlled, double-blind phase 3 study that evaluates the efficacy and safety of Otezla in the treatment of mild to moderate plaque psoriasis
.
Mild to moderate plaque psoriasis is defined as: body surface area (BSA) involvement of 2%-15%, psoriasis area and severity index (PASI) score of 2-15, static physician overall assessment (sPGA) score For 2-3 points
.
In this study, 595 patients were randomly divided into 2 groups at a ratio of 1:1.
One group received Otezla 30 mg orally (n=297) twice a day, and the other received placebo (n=298) for a period of 16 Weeks of treatment
.
After completing 16 weeks of treatment, all patients received Otezla treatment during the open label expansion period until the 32nd week
.
The primary endpoint was the percentage of patients who achieved an sPGA response at week 16
.
The sPGA response is defined as the sPGA score skin lesion removal (0 points) or almost complete removal (1 points), and a reduction of at least 2 points compared with baseline
.

.

The results showed that the study reached the primary endpoint: at the 16th week of treatment, compared with the placebo group, a significantly higher proportion of patients in the Otezla treatment group achieved an sPGA 0/1 response (21.
6% vs 4.
1%, p<0.
0001)
.
These clinical improvements continued until the 32nd week
.

In addition, at the 16th week of treatment, compared with the placebo group, the Otezla treatment group had a statistically significant improvement in all secondary endpoints, including: a higher proportion of patients with BSA ≤ 5% achieved BSA ≤ 3% (71.
7% vs 35.
8%), BSA improved at least 75% (29.
0% vs 6.
1%), and the scalp PGA (ScPGA) response score was complete or almost complete removal of the skin (ScPGA 0/1: 35.
6% vs 12.
9%)
.

In adult patients with BSA>5%, a consistent improvement in disease severity was also achieved
.
At the 16th week of treatment, compared with the placebo group, a higher proportion of patients in the Otezla treatment group with BSA>5% achieved BSA≤3% (54.
6% vs 14.
9%), and BSA improved at least 75% (36.
8% vs 8.
6%) ), ScPGA response score is 0/1 (50.
6% vs 19.
2%)
.

In this trial, the adverse events observed are consistent with the known safety characteristics of Otezla
.
In the Otezla treatment group, the most commonly reported (≥5%) adverse events (TEAE) during treatment were diarrhea (14.
3%), headache (12.
9%), nausea (12.
7%), upper respiratory tract infection (8.
5%) and Nasopharyngitis (6.
8%)
.

Psoriasis is a serious chronic inflammatory disease that can cause raised red scales on the skin, usually affecting the elbows, knees, or the outside of the scalp, but it can also appear anywhere
.
About 125 million people worldwide suffer from psoriasis, including about 14 million in Europe and more than 7.
5 million in the United States
.
About 80% of these patients have plaque psoriasis
.

Otezla (apremilast) is an oral selective phosphodiesterase 4 (PDE4) small molecule inhibitor that regulates the network of pro-inflammatory and anti-inflammatory mediators in cells
.
PDE4 is a cyclic adenosine monophosphate (cAMP) specific PDE, and it is the main PDE in inflammatory cells
.
PDE4 inhibition leads to an increase in intracellular cAMP levels, which is thought to indirectly regulate the production of inflammatory mediators
.
The specific mechanism of Otezla's therapeutic effect in patients is still unclear
.

At present, Otezla has been approved for 3 treatment indications: (1) treatment of adult patients with moderate to severe plaque psoriasis; (2) treatment of adult patients with active psoriatic arthritis; (3) treatment with Behcet Adult patients with disease-related oral ulcers
.
Since it was first approved for marketing by the US FDA in 2014, more than 250,000 patients with moderate to severe plaque psoriasis or active psoriatic arthritis have received Otezla treatment in the United States
.
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Original Source: OTEZLA (apremilast) Significantly Improved Measures Of Disease Severity In Adults With Mild-To-Moderate Plaque Psoriasis