Jamp Tofacitinib

For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:

A. i) Methotrexate (20mg/week) for at least 3 months, AND

ii) leflunomide (20mg/day) for at least 3 months, in addition to

iii) an adequate trial of at least one combination of DMARDs for 3 months; OR

B. i) Methotrexate (20mg/week) for at least 3 months, AND

ii) leflunomide in combination with methotrexate for at least 3 months; OR

C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.)

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year.

For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.

Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.

The recommended dosing regimen is 5mg administered twice daily

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.

The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks.

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 Xeljanz or be off corticosteroids after the first year of treatment.

The recommended dosing regimen is 5mg twice daily.

Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.

For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of methotrexate (i.e. 15 mg/m² per week) for at least 3 months. Optimal route of methotrexate to be determined by the clinician.

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline result prior to the start of treatment in the previous year.

For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.

Recommended dose:

In children weighing 40 kg or more, 5 mg administered orally twice a day.

Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.

Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.