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US 2026/0295023 A1Published application
Methods Of Treating Plantar Fibromatosis
OwnerJames P. Tursi, Luis A. Ortega +4inventors
InventorsJames P. Tursi, Luis A. Ortega, Qinfang Xiang, Saji Vijayan, Jeffrey David Lehrman, David Hernandez
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Abstract
Disclosed herein are methods of treating plantar fibromatosis in a subject or a population of subjects.
Claims35
A method of treating moderate to severe plantar fibromatosis in a subject or a population of subjects, the method comprising:
- intralesionally injecting a pharmaceutical formulation comprising collagenase into one or more plantar fibromatosis nodules in one or both of the subject's feet or the population of subjects' feet to thereby treat the plantar fibromatosis, wherein the dose of collagenase administered per nodule comprises about 0.45 mg to about 1.35 mg and the treating comprises:
- a reduction from baseline as measured on a foot function index (FFI) pain sub scale;
- a reduction from baseline as measured on a FFI combined pain and difficulty subscale;
- an improvement from baseline as measured on a patient global impression of change (PGIC)-PF overall scale;
- a reduction from baseline as measured on a FFI total composite score;
- an improvement from baseline as measured on a subject satisfaction with treatment scale;
- a reduction from baseline in LSM FFI Foot Pain score;
- a reduction from baseline in combined FFI pain and Difficulty score;
- an improvement from baseline in nodule consistency;
- a reduction from baseline in the nodular hardness;
- or any combination thereof.
8 more elements
A method of treating moderate to severe plantar fibromatosis in a subject or a population of subjects by administering a collagenase enzyme at a dose of about 0.45 mg to about 1.35 mg per nodule, the collagenase enzyme comprising:
- means for breaking down collagen type I, collagen type III, and combinations thereof,
- wherein the treating comprises:
- a reduction from baseline as measured on a foot function index (FFI) pain sub scale;
- a reduction from baseline as measured on a FFI combined pain and difficulty subscale;
- an improvement from baseline as measured on a patient global impression of change (PGIC)-PF overall scale;
- a reduction from baseline as measured on a FFI total composite score;
- an improvement from baseline as measured on a subject satisfaction with treatment scale;
- a reduction from baseline in LSM FFI Foot Pain score;
- a reduction from baseline in combined FFI pain and Difficulty score;
- an improvement from baseline in nodule consistency;
- a reduction from baseline in the nodular hardness;
- or any combination thereof.
9 more elements
A method of treating moderate to severe plantar fibromatosis in a subject or a population of subjects, the method comprising:
- intralesionally injecting a pharmaceutical formulation comprising collagenase into one or more plantar fibromatosis nodules in one or both of the subject's feet or the population of subjects' feet to thereby treat the plantar fibromatosis, wherein the dose of collagenase administered per nodule comprises about 0.6 mg, and the treating comprises:
- a reduction from baseline in the weekly mean of the average daily pain (ADP) score;
- a reduction from baseline in the FFI Difficulty Subscale score of the FFI;
- a reduction from baseline on the FFI Activity Limitation Subscale score;
- a reduction from baseline in the weekly mean of the ADP score;
- a reduction from baseline on the FFI Pain Subscale score;
- a reduction from baseline on the FFI Total score;
- an improvement from baseline on the PGIS PF Overall score;
- an improvement from baseline on the PGIS Foot Pain Subscale;
- an improvement from baseline on the PGIS Difficulty Subscale;
- an improvement from baseline on the PGIS Activity Limitation Subscale;
- an improvement from baseline in nodule consistency (firmness);
- a reduction from baseline in the nodular hardness;
- a reduction from baseline in LSM FFI Foot Pain score;
- a reduction from baseline in combined FFI pain and Difficulty score;
- or any combination thereof.
13 more elements
A method of treating moderate to severe plantar fibromatosis in a subject or a population of subjects by administering a collagenase enzyme at a dose of about 0.6 mg per nodule, the collagenase enzyme comprising:
- means for breaking down collagen type I, collagen type III, and combinations thereof
- wherein the treating comprises:
- a reduction from baseline in the weekly mean of the average daily pain (ADP) score;
- a reduction from baseline in the FFI Difficulty Subscale score of the FFI;
- a reduction from baseline on the FFI Activity Limitation Subscale score;
- a reduction from baseline in the weekly mean of the ADP score;
- a reduction from baseline on the FFI Pain Subscale score;
- a reduction from baseline on the FFI Total score;
- an improvement from baseline on the PGIS PF Overall score;
- an improvement from baseline on the PGIS Foot Pain Subscale;
- an improvement from baseline on the PGIS Difficulty Subscale;
- an improvement from baseline on the PGIS Activity Limitation Subscale;
- an improvement from baseline in nodule consistency (firmness);
- a reduction from baseline in the nodular hardness;
- a reduction from baseline in LSM FFI Foot Pain score;
- a reduction from baseline in combined FFI pain and Difficulty score;
- or any combination thereof.
14 more elements
Dependencies are inferred from the claim text.