| 684 | For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
a. Mayo score between 6 and 10 (inclusive) AND
b. Endoscopic* subscore of 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
2. Severe disease
a. Mayo score greater than 10 AND
b. Endoscopy* subscore of greater than or equal to 2 AND
c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent)
OR
d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).
*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.
Maintenance/Renewal:
Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with upadacitinib or be off corticosteroids after the first year of treatment.
Approved Dose:
Induction: Up to 45mg once daily for 8 weeks
Maintenance: 15mg or 30mg once daily.
For patients greater or equal to 65 years of age, the maintenance dose is 15mg once daily.
Depending on therapeutic response, 30mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. |
