Ixekizumab ( Taltz ) met the primary and all major secondary endpoints up to week 12 in the phase 4 IXORA-R study, which evaluated the efficacy and safety of Ixekizumab versus Guselkumab ( Tremfya ) in people living with moderate to severe plaque psoriasis.
The IXORA-R trial is the first completed head-to-head ( H2H ) trial between an IL-17A inhibitor and an IL-23/p19 inhibitor using the Psoriasis Area Severity Index ( PASI ) 100 score as the primary endpoint.
At 12 weeks, Ixekizumab met the primary endpoint by demonstrating superiority in the proportion of patients achieving complete skin clearance compared to Guselkumab as measured by PASI 100.
In addition, Ixekizumab met all major secondary endpoints up to week 12, which include superiority over Guselkumab in the proportion of patients achieving PASI 75 at week 2, PASI 90 at weeks 4 and 8, PASI 100 at weeks 4 and 8, static Physician's Global Assessment ( sPGA ) 0 at week 12 and PASI 50 at week 1.
A total of 1,027 patients with moderate to severe plaque psoriasis were enrolled in the study to evaluate the efficacy and safety of Ixekizumab compared to Guselkumab.
Participants were randomized to receive Ixekizumab ( 160 mg at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks ) or Guselkumab ( 100 mg administered by subcutaneous injection at week 0, week 4 and every 8 weeks thereafter ) for a total of 24 weeks, with the primary analysis conducted at 12 weeks.
In IXORA-R, the safety profile of Ixekizumab was consistent with previously reported results. No new safety signals were detected.
Most common adverse reactions ( more than 1% ) associated with Ixekizumab treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.
Ixekizumab is a monoclonal antibody that selectively binds with interleukin 17A ( IL-17A ) cytokine and inhibits its interaction with the IL-17 receptor.
IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.
Ixekizumab inhibits the release of pro-inflammatory cytokines and chemokines.
Taltz is approved to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Taltz is also approved for the treatment of adults with active psoriatic arthritis. ( Xagena )
Source: Eli Lilly, 2019