48 weeks! New psoriasis drugs for pregnant women approved

Source: UCB, a pharmaceutical company headquartered in Brussels, Belgium, on June 1, 2018, announced that FDA approved the expansion of the indications of cimzia (certolizumab pegol) to adult patients with moderate to severe plaque psoriasis (PSO) Cimzia will be suitable for adult patients with moderate to severe PSO who are ready for systemic or phototherapy This approval makes cimzia the first FC free, pegylated anti-tumor necrosis factor (TNF) drug for this indication In addition, FDA has updated the label of cimzia for pregnant and lactating patients, which provides important reference information for medical staff and women Psoriasis is a common chronic inflammatory skin disease, affecting nearly 3% of the world's population (125 million people) Although symptoms vary from patient to patient, they may include red patches covered with silver scales, dry, chapped, bleeding, and thickened, sunken, or raised nails For patients with severe symptoms, psoriasis has a significant impact on their quality of life Despite advances in drug development in this area over the past decade, patient survey data show that patients with moderate to severe psoriasis do not receive adequate treatment Cimzia is an antibody drug for TNF α, more specifically, it is a PEGylated Fab 'fragment of monoclonal antibody of humanized TNF inhibitor Cimzia is a hypodermic drug that has been used in the past to prevent inflammation caused by overactive immune system and to treat moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and moderate to severe Crohn's disease PEGylation has been shown to help drug retention in vivo This time, cimzia was approved for expanding indications based on data from a phase 3 clinical study The study consisted of three clinical trials, cimpasi-1, cimpasi-2 and cimpact The trials recruited more than 1000 patients, nearly a third of whom had been treated with biological agents Each of the three studies included an assessment of the proportion of patients who achieved at least 75% and 90% improvement from baseline, measured by psoriasis area and severity indices (PASI 75 and PASI 90, respectively) In all three trials, cimzia reached the primary endpoint and the common primary endpoint at all doses compared to placebo, and clinical benefits continued to 48 weeks It should be noted that these results are based on four-year efficacy and safety data of psoriatic arthritis (PSA), so they are of great significance In addition, FDA has updated the labels for pregnancy and lactation based on the new study, indicating that the drug placenta metastasis level is very low or negligible ▲ Dr Emmanuel caeymaex, head of immunology and executive vice president of immune patient value Department of UCB (photo source: Official Website of UCB) Alice, professor and chief researcher of Dermatology, New York Medical College Dr Gottlieb said: "in the phase 3 clinical project of plaque psoriasis, cimzia showed a statistically significant improvement at the 16th week, reaching the end point of curative effect, and the clinical improvement lasted until the 48th week These remarkable evidences are of great significance to psoriasis patients, because in addition to the obvious physical symptoms, they also have a huge psychological and emotional burden, and the social burden caused by them The approved expanded indications provide patients and medical professionals with a solid choice of new biological agents that can provide lasting disease control Cimzia's two dose regimens also allow patients to customize therapy Cimzia has shown similar efficacy in patients who have never been treated with other biological agents or in patients who have been treated " Dr Emmanuel caeymaex, head of immunology and executive vice president of UCB's immunopatient value department, said: "cimzia is the first FDA approved, FC free human monoclonal antibody for the treatment of this challenging skin disease The approval is based on UCB's 10 years of market experience, as well as cimzia's demonstrated efficacy and safety in a variety of inflammatory diseases The FDA's approval of cimzia for the treatment of psoriasis, as well as the label update for chronic inflammation in pregnant and lactating women, is an important progress in the treatment " Dr Michael Siegel, senior vice president of research and Clinical Affairs, National Psoriasis Foundation, said: "given the unique nature of psoriasis, it is essential for dermatologists to have as many choices as possible to find the right treatment for each patient Dermatologists and patients are looking forward to the new drug to bring them more treatment improvements " We hope that the expanded indications of cimzia will benefit more psoriasis patients, especially those women in pregnancy and lactation, who can safely use drugs under the guidance of doctors.