Date: 2017-03-04
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Academy of Dermatology (AAD) Annual Meeting
Company: Eli Lilly (USA - IN)
Product: Taltz® (ixekizumab)
Action
mechanism:
- monoclonal antibody. Ixekizumab is a monoclonal antibody with high affinity and specificity that binds to and neutralizes the pro-inflammatory cytokine interleukin-17A (IL-17A). In psoriasis, IL-17A plays a major role in driving excess keratinocyte (skin cell) proliferation and activation. Ixekizumab does not bind to cytokines IL-17B, IL-17C, IL-17D, IL-17E or IL-17F. Ixekizumab is administered via subcutaneous injection.
- Taltz® (ixekizumab) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Disease: plaque psoriasis
Therapeutic
area: Autoimmune diseases - Dermatological diseases
Country: Austria, Belgium, Canada, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, UK
Trial
details:
- The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis. (NCT02561806)
Latest
news:
- • On March 4, 2017, Eli Lilly announced that patients with moderate-to-severe plaque psoriasis treated with Taltz® (ixekizumab) demonstrated superior efficacy at 24 weeks compared to patients treated with Stelara® (ustekinumab).
- At 24 weeks, patients treated with Taltz® achieved significantly higher response rates compared to patients treated with Stelara®, including 83 percent of patients who achieved Psoriasis Area Severity Index (PASI) 90—the study's primary endpoint—compared to 59 percent of patients who achieved PASI 90 after treatment with Stelara.
- In the IXORA-S study, patients were randomized to receive either Stelara® (45 mg or 90 mg weight-based dosing per label) or Taltz® (80 mg every two weeks for 12 weeks followed by 80 mg every four weeks), following a 160-mg starting dose, for a total of 52 weeks.
- This study also evaluated PASI 75, PASI 100 and static Physician's Global Assessment score (sPGA) 0 or 1 with at least a two-point improvement from baseline. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin.
- At 24 weeks, patients treated with Taltz® achieved significantly higher response rates compared to patients treated with Stelara, as demonstrated by the following:
- 91.2 percent of patients treated with Taltz® achieved PASI 75 compared to 81.9 percent of patients treated with Stelara® ;
83.1 percent of patients treated with Taltz® achieved PASI 90 compared to 59.0 percent of patients treated with Stelara®;
- 49.3 percent of patients treated with Taltz® achieved PASI 100 compared to 23.5 percent of patients treated with Stelara®.
- Additionally, 86.6 percent of patients treated with Taltz® achieved sPGA 0 or 1 compared to 69.3 percent of patients treated with Stelara® after 24 weeks (p < 0.001).
- The majority of treatment-emergent adverse events were mild or moderate. There were no statistically significant differences between treatment groups in overall treatment-emergent adverse events. The safety profile for Taltz was consistent with previous clinical trials.
- Detailed results from the IXORA-S study were presented during the American Academy of Dermatology (AAD) Annual Meeting taking place March 3-7 in Orlando, Fla.
Is
general: Yes
