Phase IIIb/IV SPIRIT-H2H study of Taltz shows efficacy in psoriatic arthritis.- Eli Lilly

Eli Lilly shared new results from a subgroup analysis of the Phase IIIb/IV, 52-week SPIRIT-Head-to-Head (SPIRIT-H2H) study of Taltz (ixekizumab) versus Humira (adalimumab) in biologic-naïve patients with active psoriatic arthritis (PsA). SPIRIT-H2H was the first superiority study versus Humira in PsA with a primary endpoint of simultaneous achievement of ACR50 (at least 50% improvement in disease activity as defined by the American College of Rheumatology) and PASI 100 (100% improvement in the Psoriasis Area and Severity Index) at Week 24. In this prespecified analysis, efficacy outcomes through Week 52 were compared between Taltz and Humira in subgroups of patients on monotherapy, concomitant methotrexate (MTX), or concomitant MTX along with an additional conventional synthetic disease-modifying antirheumatic drug (csDMARD), including sulfasalazine, cyclosporine, or leflunomide.

Results at 52 weeks showed improvements were seen with Taltz across multiple endpoints, with or without the use of MTX or other csDMARDs. A higher proportion of patients treated with Taltz achieved Minimal Disease Activity (MDA) compared to Humira in the monotherapy subgroup (49% versus 33%), while response rates were similar between Taltz and Humira in the concomitant MTX subgroup (47% vs 47%) and concomitant csDMARD subgroup (47% vs 44%). MDA is an endpoint that includes fulfilling at least five of seven rheumatology outcome measures and is the treatment target according to multiple professional organizations. More Taltz patients achieved the primary endpoint of simultaneous achievement of ACR50 and PASI 100 at Week 52 in all three subgroups: Monotherapy: Taltz 38%, Humira 19%. Concomitant MTX: Taltz 39%, Humira 30%. Concomitant csDMARDS: Taltz 40%, Humira 29%.

A greater proportion of patients treated with Taltz versus Humira achieved PASI 100 when used as monotherapy (66% vs 35%), in combination with MTX (63% vs 44%), or in combination with csDMARDs (64% vs 44%) and the proportion of patients achieving ACR50 was comparable between Taltz and Humira, regardless of monotherapy (51% vs 42%), concomitant MTX (48% vs 56%), or concomitant csDMARD use (49% vs 53%). The observed safety profile for Taltz in the SPIRIT-H2H study was consistent with that reported for ixekizumab in patients with moderate to severe plaque psoriasis (PsO) and PsA. Data will be presented virtually on June 5 at the European Congress of Rheumatology 2020 (EULAR).