Successful SPIRIT- P1 study of Taltz (ixekizumab) to treat psoriatic arthritis.- Eli Lilly

Eli Lilly and Company announced that the majority of patients with active psoriatic arthritis (PsA) treated with Taltz (ixekizumab) exhibited either no progression or minimal progression of radiographic structural joint damage through 52 weeks of treatment. Detailed results from the extension period of the SPIRIT-P1 trial will be presented in an oral presentation today during the Annual European Congress of Rheumatology (EULAR) 2017, taking place June 14-17, in Madrid.

During the 24-week, double-blind period of the SPIRIT-P1 study, patients with active PsA who had never received a biologic disease-modifying antirheumatic drug (bDMARD) were treated with either 80 mg of Taltz once every two weeks or every four weeks (following a 160-mg starting dose), or adalimumab at the approved dose of 40 mg every two weeks or placebo. Adalimumab was employed as an active control in the SPIRIT-P1 study and was not powered for comparison with Taltz treatment groups. Following completion of the 24-week treatment period, patients were re-randomized to receive 80 mg of Taltz every two weeks or four weeks to evaluate response rates during the extension period through 52 weeks. Patients treated with Taltz at both dosing regimens experienced either no progression or minimal radiographic progression of structural joint damage as measured by the change from baseline in the van der Heijde modified Total Sharp Score (mTSS) for PsA at 52 weeks. No progression or minimal radiographic progression of structural joint damage was also observed for patients who switched from placebo or adalimumab to either dosing regimen of Taltz after the 24-week treatment period.

During the extension period of SPIRIT-P1, the incidence of treatment-emergent adverse events was greater with Taltz treatment compared with placebo. The most common ( greater than 4 percent) treatment-emergent adverse events observed in all patients treated with Taltz were nasopharyngitis and injection site reaction. These events are consistent with those reported in the Phase III studies of Taltz for the treatment of moderate-to-severe plaque psoriasis (UNCOVER 1, 2, 3).