The State Food and Drug Administration approves the listing of new drugs for the treatment of psoriasis

The State Food and Drug Administration approves the listing of new drugs for the treatment of psoriasis

The State Food and Drug Administration approves the listing of new drugs for the treatment of psoriasis The State Food and Drug Administration approves the listing of new drugs for the treatment of psoriasis

At present, there are about 6.
5 million patients with psoriasis in China, and about 57.
3% of patients with moderate to severe psoriasis.
Although the treatment of psoriasis has been enriched in recent years, the compliance of patients with treatment is still not ideal
.

A transnational study on psoriasis and psoriatic arthritis published in the Journal of the American Academy of Dermatology showed that 57% of patients using traditional oral treatments and 45% of patients using biological agents, because of the safety and resistance of the drugs Stop treatment due to problems with sex or effectiveness

On August 17th, the National Medical Products Administration approved the innovative oral targeted drug Otara (apmilast tablets) developed by Amgen in the United States to be marketed in China for the treatment of moderate to moderate levels that meet the indications for receiving phototherapy or systemic therapy.
For adult patients with severe plaque psoriasis, Apmilast is the first and only oral phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of plaque psoriasis in China
.

Director of the Chinese Medical Association credits will Dermatology Psoriasis committee member and chief expert, director of the Dermatology Institute of Fudan University Professor Zhang Xuejun said: "The advent of oral medication has targeted milestone for the treatment of psoriasis
tradition.

Most of the oral drugs are broad-spectrum immunosuppressants, which may bring some side effects while improving the symptoms of the disease

Committee member

Apomilast is a small molecule phosphodiesterase-4 (PDE-4) inhibitor
.

PDE-4 is a cyclic adenosine monophosphate (cAMP) specific hydrolase, expressed in a variety of inflammatory cells

Two key phase III clinical studies ESSTEEM1 and ESSTEEM2 showed that apramilast treated patients with moderate to severe plaque psoriasis reaching PASI (psoriatic lesion area and severity index) 75 and PASI 50 at 16 weeks The ratios were 33.
1% and 55.
5%, which were significantly better than placebo, and significantly improved the pathological changes of patients' nails, scalp, palms and soles and other refractory parts
.

The results of a three-year long-term follow-up showed that apramilast has good safety in the treatment of psoriasis, no serious adverse reactions such as liver and kidney toxicity and bone marrow suppression, no recurrence of tuberculosis, and most of the common adverse reactions are mild to moderate and may be more than Remission within 1 month

Professor Zhang Xuejun said that it is well known that psoriasis has four properties, namely chronic, recurrent, inflammatory and systemic
.

Apomilast can effectively control psoriasis for a long time, reduce the recurrence of the disease, relieve the inflammation of psoriasis from the mechanism, improve the comorbidity of psoriasis, and fully meet the treatment needs of patients with psoriasis