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Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies.


ABSTRACT:

Background

The efficacy and safety of ixekizumab (IXE) with and without continuous concomitant methotrexate (MTX), for up to 52?weeks of treatment, were evaluated in patients with active psoriatic arthritis (PsA).

Methods

Patients with active PsA who were biologic-naive (SPIRIT-P1) or had prior inadequate response to tumor necrosis factor inhibitors (SPIRIT-P2) were randomized to 80?mg IXE every 4 (IXE Q4W) or 2?weeks (IXE Q2W), after a 160-mg initial dose. In this post hoc analysis, efficacy and safety were assessed up to week 52 in the subgroups of patients who received (i) IXE as monotherapy and (ii) IXE along with a stable dose of MTX (no dose tapering or increase). Efficacy outcomes included, but were not limited to, the percentage of patients achieving the American College of Rheumatology (ACR) responses.

Results

Out of 455 patients initially randomized to IXE, 177 (38.9%) received monotherapy, 230 (50.5%) had concomitant MTX use, and 48 (10.5%) had other concomitant medication. Overall, 183 (40.2%) received IXE with a stable dose of concomitant MTX for 1?year. At week 52, the percentage of patients achieving ACR20/50/70 responses in IXE Q4W monotherapy versus concomitant MTX groups were 66.3% versus 55.3%, 48.4% versus 38.8%, and 35.8% versus 27.1%, respectively; these responses were generally similar with IXE Q2W. The safety profiles were similar between patients receiving IXE with or without concomitant MTX.

Conclusions

In this post hoc analysis, treatment with IXE demonstrated sustained efficacy in patients with PsA up to 1?year of treatment, with or without concomitant MTX therapy.

Trial registration

ClinicalTrials.gov NCT01695239 and NCT02349295 .

SUBMITTER: Combe B 

PROVIDER: S-EPMC7839215 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies.

Combe Bernard B   Tsai Tsen-Fang TF   Huffstutter J Eugene JE   Sprabery Aubrey Trevelin AT   Lin Chen-Yen CY   Park So Young SY   Kronbergs Andris A   Hufford Matthew M MM   Nash Peter P  

Arthritis research & therapy 20210127 1


<h4>Background</h4>The efficacy and safety of ixekizumab (IXE) with and without continuous concomitant methotrexate (MTX), for up to 52 weeks of treatment, were evaluated in patients with active psoriatic arthritis (PsA).<h4>Methods</h4>Patients with active PsA who were biologic-naive (SPIRIT-P1) or had prior inadequate response to tumor necrosis factor inhibitors (SPIRIT-P2) were randomized to 80 mg IXE every 4 (IXE Q4W) or 2 weeks (IXE Q2W), after a 160-mg initial dose. In this post hoc analys  ...[more]

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