Results from a Phase II, randomized, double-blind,placebo-controlled, dose-ranging trial designed to evaluate theefficacy and safety of brodalumab (formerly AMG 827) in 198patients with moderate to severe plaque psoriasis have been published in the New England Journal of Medicine. The researchers of the 12 week study randomly assigned participantswith a psoriasis area and severity index (PASI) score of 12 or moreand affected body surface area 10 percent or more to receivebrodalumab (70 mg, 140 mg or 210 mg at day one and weeks 1,2,4,6,8and 10 or 280 mg monthly), or placebo. The primary endpoint of the study was achieved in all brodalumaggroups, whose average improvement in psoriasis area (in percentage)and severity index (PASI) was higher than those of patients in theplacebo group (p 0.001). Brodalumab is a human monoclonal antibody designed for thetreatment of inflammatory diseases. The drug selectively attachesto and prevents signaling through the interleukin-17 (IL-17)receptor, thus inhibiting the attachment of many IL-17 familymembers linked to psoriasis.
Many study participants (62%)receiving brodalumab 210 mg every other week achieved totalclearance of their skin disease (PASI 100). PASI score is a measure of psoriatic plaque redness, scaling, andthickness and the magnitude of involvement in each area of thebody. Researchers often measure how effective a treatment is by thereduction of PASI from baseline. For example, a reduction of 75% isknown as PASI 75, a reduction of 90% is known as PASI 90, and totalclearance of skin disease is known as PASI 100. Kim Papp, M.D., Ph.D., lead author of the study and director atProbity Medical Research, Ontario, Canada, said: "There are a variety of treatment options available to those livingwith psoriasis, yet these options are unable to help many patientsachieve their therapeutic goals.
In this Phase 2 study, brodalumab showed a high level of responsein patients with moderate to severe plaque psoriasis with a rapidonset of action within days. Based on these results, additionalclinical trials are warranted to further assess the safety andefficacy of brodalumab." Psoriasis is a chronic disease of the immune system that causes theskin cells to grow at a faster rate. Worldwide, the conditionaffects around 125 million individuals. Even though several typesof psoriasis exist, around 80% of sufferers have plaque psoriasis.Plaque psoriasis can cause painful and itchy red, scaly patches toappear on the skin.
In this study, the researchers found that participants who received140 mg of brodalumab every other week had a mean improvement inPASI score of 85.9%, 86.3% among participants who received 210 mg,and 45.0% for 70 mg, compared with 16.0% among participants whoreceived placebo (all p 0.001). In addition, the researchers found that 280 mg of broadlumabmonthly was associated with a mean PASI improvement of 76%. Around30% of study participants assigned to the place group had worseningpsoriasis. Furthermore, the team assessed secondary endpoints including PASI75 (75% reduction in patient PASI score from baseline), PASI 90(90%) and PASI 100 (total clearance of skin disease). 77% of participants assigned to 140 mg of brodalumab achieved a 75%reduction in their PASI score, 72% achieved PASI 90, and 38%achieved PASI 100.
82% of participants assigned to 210 mg of brodalumab achieved a 75%reduction, 75% achieved PASI 90, and 62% achieved PASI 100. In the combined brodalumab groups, the most commonly reported sideeffects were: Injection site redness (6%) Common Cold (8%) Upper respiratory tract infection (8%) Among participants in the 210 mg brodalumab group, two cases ofgrade three neutropenia were reported. At present, brodalumab is the only experimental drug in developmentthat inhibits the IL-17 receptor, thus inhibiting several of theIL-17 ligands at once from transmitting signals to the body. Otheragents currently in development seek to target the individual IL-17ligands. By inhibiting the attachment of these ligands with thereceptor, brodalumab stops the body from receiving signals that mayotherwise cause inflammation and other ailments.
Researchers are currently investigating brodalumab for thetreatment of psoriasis (Phase II and planned Phase III), asthma (Phase II), and psoriatic arthritis (Phase II). Written by Grace Rattue Copyright: Medical News Today Not to be reproduced without permission of Medical News Today Additional References Citations. I am a professional writer from Home & Garden, which contains a great deal of information about touch and sew , lion wall fountain, welcome to visit!
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