Methods for the treatment of psoriatic arthritis
Inventors
HARRISON, Pille • MEULENERS, Luc • TASSET, Chantal Thérèse
Assignees
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Publication Number
US-12329758-B2
Publication Date
2025-06-17
Expiration Date
Abstract
The present invention relates to compound according to Formula I: or a pharmaceutically acceptable salt thereof, or a solvate or the salt of a solvate thereof, pharmaceutical compositions comprising the same, and methods of treatment using the same, for use in the treatment of psoriatic arthritis, by administering the compound according to Formula I.
Core Innovation
A method is described for treating a patient diagnosed with psoriatic arthritis by administering a compound according to formula I, or a pharmaceutically acceptable salt thereof, or a solvate or the salt of a solvate thereof. The compound is Compound I as defined by the chemical description provided in the document and is positioned as a selective JAK1 inhibitor with selectivity relative to JAK2. The document also introduces an active metabolite, Compound II.
The problem addressed is the treatment of psoriatic arthritis in patient populations defined by prior exposure history, including patients who have never been exposed to anti-TNF treatment or who have not had an inadequate response prior to anti-TNF treatment. Clinical evaluation is described using ACR response criteria, enthesitis indices, minimal disease activity, and psoriasis-related measures, together with functional assessment and associated disease scoring terminology.
The method is characterized by dosing and duration, including daily dosing within a specified range and treatment for at least 16 weeks. The documented clinical data are described as Phase 2 outcomes over 1 to 16 weeks, reporting proportions of ACR20/ACR50/ACR70 responders and enthesitis-related outcomes using Leeds Enthesitis Index (LEI) and SPARCC Enthesitis Index, alongside psoriasis severity measures and patient-reported functional outcomes.
Claims Coverage
The independent claim covers a single method of treatment comprising multiple inventive features, centered on administering a formula I compound (or pharmaceutically acceptable salt/solvate) at specified daily dose levels for at least 16 weeks to anti-TNF–naïve psoriatic arthritis patients. The coverage includes patient-selection constraints and treatment-duration constraints, with dependent claims adding quantitative ACR and LEI response criteria and restricting concomitant psoriatic arthritis and/or anti-TNF therapy.
Formula I compound administration for psoriatic arthritis
A method for treating a patient diagnosed with psoriatic arthritis comprising administering a compound according to formula I, or a pharmaceutically acceptable salt thereof, or a solvate or the salt of a solvate thereof to the patient.
Daily dosing range for at least 16 weeks
Administering the formula I compound at a daily dose of 100 to 200 mg for a period of at least 16 weeks.
Anti-TNF exposure–based patient selection
Treating a patient who has never been exposed to anti-TNF treatment or had an inadequate response prior to anti-TNF treatment.
ACR20-based treatment effect criterion
The treatment produces a treatment effect characterized by an American College of Rheumatology (ACR)20-score of at least 70%.
ACR50-based treatment effect criterion
The treatment produces a therapeutic effect with an American College of Rheumatology (ACR50) score of at least 40%.
LEI-threshold patient selection
A patient diagnosed with psoriatic arthritis having a Leeds Enthesitis Index (LEI) score greater than 0.
Quantified LEI reduction as treatment effect
A treatment effect that reduces the LEI score of at least 0.8.
Exclusion of concomitant psoriatic arthritis and/or anti-TNF treatment
The patient does not concomitantly receive any additional treatment for psoriatic arthritis, and/or does not concomitantly receive any anti-TNF treatment.
Overall, the claims cover a psoriatic arthritis treatment method using a formula I compound (or pharmaceutically acceptable salt/solvate) with defined daily dosing and minimum treatment duration, targeted to patients defined by anti-TNF exposure history. Dependent claims further define measurable efficacy using ACR20/ACR50 thresholds and LEI-based selection and response, while restricting concomitant therapies involving anti-TNF and/or additional psoriatic arthritis treatments.
Stated Advantages
Selective JAK1 inhibition is stated, with noted potency/selectivity versus JAK2.
Clinical efficacy is reported using ACR response criteria, enthesitis reduction (LEI), and minimal disease activity in a Phase 2 study context.
Documented Applications
Treating a patient diagnosed with psoriatic arthritis, including patients who have never been exposed to anti-TNF treatment or have not had an inadequate response prior to anti-TNF treatment, using a compound according to formula I for at least 16 weeks.
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