Ixekizumab clears skin and reduces itching in Plaque Psoriasis in kids finds phase 3 study
Taltz (ixekizumab) has the potential to clear skin and reduce itch in children with moderate to severe plaque psoriasis, according to results from a phase 3 study presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain.
Ixekizumab is the first and only IL-17A inhibitor with published clinical trial results in pediatric patients with moderate to severe plaque psoriasis. Ixekizumab is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is also approved for the treatment of adults with active psoriatic arthritis and active ankylosing spondylitis.
According to the pharmaceutical company Eli Lilly and Company, Taltz met co-primary endpoints as well as all major secondary endpoints.
89 percent of patients treated with Taltz achieved a significant 75 percent improvement from baseline to Week 12 on their Psoriasis Area and Severity Index score (PASI 75) and 81 percent of patients treated with Taltz achieved a static Physician's Global Assessment of clear or almost clear skin.
Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis.
According to the National Psoriasis Foundation, plaque psoriasis is the most common form of the disease. 80-90 percent of people with psoriasis experience plaque psoriasis. On Caucasian skin, psoriasis typically appears as raised, red patches covered with a silvery-white buildup of dead skin cells or scale. On skin of colour, the discolouration is darker and thicker, more of a purple or greyish colour or darker brown.
"While it is estimated that up to one-third of people with psoriasis first develop symptoms during childhood, there are limited medications available for pediatric patients. This study provides encouraging data supporting the potential for Taltz to become another treatment option for this patient population," Kim Papp, Probity Medical Research, Inc., Waterloo, Ontario, Canada, said in a press release.
The co-primary endpoints of the study were the proportion of patients achieving a significant 75 percent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12. Key secondary endpoints included the proportion of patients achieving PASI 90, sPGA (0) and PASI 100 at Week 12, and at least a four-point improvement in Itch Numeric Rating Scale (Itch NRS ≥4) among patients with baseline Itch NRS ≥4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4. The proportion of patients achieving 0 or 1 on the Children's Dermatology Life Quality Index (CDLQI, patients 6 to 16 years old) or DLQI (patients ≥17 years old) at Week 12 was also evaluated.
"We recognize that psoriasis can have a significant impact on children and adolescents, causing challenging symptoms and affecting their self-esteem and ability to connect to peers," said Lotus Mallbris, vice president of immunology development at Lilly. "We're pleased to see positive results for Taltz in pediatric patients. These results build on more than five years of safety and efficacy data in adults and support the potential for Taltz in this new population, pending regulatory approvals."
A total of 201 patients aged 6 to <18 years of age with moderate to severe plaque psoriasis were randomized to receive Taltz (20 mg for <25 kg, 40 mg for 25-50 kg or 80 mg for >50 kg through Week 12, with 40 mg, 80 mg or 160 mg starting doses, respectively) or placebo. At 12 weeks, the proportion of patients achieving the co-primary endpoints was superior to placebo with statistically significant difference (P<0.001), including:
- 89 percent of patients treated with Taltz achieved PASI 75 compared to 25 percent of patients treated with placebo.
- 81 percent of patients treated with Taltz achieved sPGA 0,1 compared to 11 percent of patients treated with placebo.
Taltz also met all major secondary endpoints in the study.
In this trial, the overall safety profile of Taltz was consistent with previously reported results. The Taltz safety profile has been studied across 15 clinical trials in plaque psoriasis and psoriatic arthritis, with 6,989 patients receiving Taltz, with a total exposure of 16,586 patient-years.