Taltz v Humira in psoriatic arthritis study

[Fred]

Eli Lilly shared new results from a subgroup analysis of the Phase 3b/4, 52-week Head-to-Head study of Taltz (ixekizumab) versus Humira (adalimumab) in biologic-naïve patients with active psoriatic arthritis (PsA)

Quote:

---

Eli Lilly and Company shared new results today from a subgroup analysis of the Phase 3b/4, 52-week SPIRIT-Head-to-Head (SPIRIT-H2H) study of Taltz 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%).

"In this subgroup analysis of the SPIRIT-H2H study, ixekizumab showed greater improvement than adalimumab across multiple PsA endpoints when taken as monotherapy, and at least comparable efficacy when used in combination with methotrexate or other csDMARDs," said Josef Smolen, M.D., emeritus professor of medicine at the Medical University of Vienna, Austria and lead author of the abstract. "Head-to-head studies provide important insights for physicians when making treatment decisions. The results of this analysis reinforce the efficacy of ixekizumab, even as monotherapy, for patients with PsA who have had an inadequate response to csDMARDs."

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.

Lilly also highlighted notable results from two additional studies. The SPIRIT-P2 study demonstrated sustained improvement in signs and symptoms of PsA, as measured by ACR responses, as well as manifestations of PsA, including enthesitis, dactylitis, and skin outcomes, for up to three years in patients with prior inadequate response or intolerance to one or two tumor necrosis factor inhibitors (TNFi). In the Phase 3 COAST-X study in patients with active non-radiographic axial spondyloarthritis (nr-axSpA), patients treated with Taltz saw improvement in fatigue, spinal pain and stiffness at Week 16. In both studies, the safety profile of Taltz was consistent with previously reported results and no unexpected safety signals were found.

"To date, Taltz has reported positive results from five H2H superiority studies across PsA and PsO, including SPIRIT-H2H, IXORA-S, UNCOVER-2, UNCOVER-3 and IXORA-R, and we're pleased to share additional data from the SPIRIT-H2H subgroup analysis which provides further evidence for the use of Taltz as a first-line monotherapy treatment for patients living with PsA," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "The full breadth of Taltz data being presented at EULAR reinforce the efficacy of Taltz in treating patients with PsA and axSpA."

Source: lilly.com

Taltz (ixekizumab)

Humira (adalimumab)

[jiml]

Interesting results and nice to see as a monotherapy it is more successful than Humira and also interesting that combined with mtx or other DMARD drugs it is even more successful,

[Caroline]

Interesting results and nice to see as a monotherapy it is more successful than Humira and also interesting  that combined with mtx or other DMARD  drugs it is even more successful,

Certainly interesting. Good results for Taltz.
I read somewhere that in NL, a study is running on Humira combined with MTX, so perhaps they are a little behind. Who knows..