Psoriatic Arthritis (PsA)
Adalimumab
- See Formulary for funded biosimilars
- Brand(s): Humira (Only for those approved for biosimilar exemption)
- Dosage Form/Strength:
- 40 mg/0.8 mL prefilled syringe
- 40 mg/0.8 mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection
Certolizumab
- Brand(s): Cimzia
- Dosage Form/Strength:
- 200 mg/mL prefilled syringe and autoinjector
Etanercept
- See Formulary for funded biosimilars
- Brand(s): Enbrel (Only for those approved for biosimilar exemption)
- Dosage Form/Strength:
- 25 mg/vial
- 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options
Golimumab
- Brand(s): Simponi
- Dosage Form/Strength:
- 50 mg/0.5 mL prefilled syringe and autoinjector
Guselkumab
- Brand(s): Tremfya
- Dosage Form/Strength:
- 100 mg/mL prefilled syringe
- Patient-controlled injector (AI)
- Effective Date: November 27, 2023
Secukinumab
- Brand(s): Cosentyx
- Dosage Form/Strength:
- 150 mg/mL prefilled syringe
- 150 mg/mL prefilled Pen
Ixekizumab
- Brand(s): Taltz
- Dosage Form/Strength:
- 80 mg/mL Autoinjector
- 80 mg/mL Syringe for subcutaneous injection
- Effective Date: March 4, 2019
Upadacitinib
- Brand(s): Rinvoq
- Dosage Form/Strength:
- 15 mg tablet
- Effective Date:
- November 16, 2022 (PsA)
- October 31, 2023 (AD)
Indications for Treatment
For the treatment of psoriatic arthritis (PsA) in patients who have:
- Severe active disease (≥ 5 swollen joints and radiographic evidence of psoriatic arthritis)
- Despite treatment with methotrexate (20 mg/week) for at least 3 months and one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months.
- If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required.
- Details of contraindications and intolerances must also be provided.
Approval Duration
- Initial Approval of Initials: 1 Year
- Renewals:
- Duration of Approval:
- First Renewal: 1 Year
- Second and Subsequent Renewals: 5 Years
- Criteria for Renewal:
- Patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year.
- For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided (i.e., the current joint count should be compared to the count prior to initiating treatment with the biologic agent).
- Duration of Approval:
Recommended Dosing Regimens
Etanercept:
- The planned dosing regimen should be provided.
- Maximum Recommended Dose: 50 mg once weekly.
Adalimumab:
- a) 24 mg/m² (maximum 40 mg) every two weeks; OR
- b) 20 mg every 2 weeks, if the patient weighs less than 30 kg; OR
- c) 40 mg every 2 weeks, if the patient weighs more than 30 kg.
Certolizumab:
- 400 mg at week 0, 2, 4
- Then maintenance doses of 200 mg every 2 weeks or 400 mg every 4 weeks
Etanercept:
- 25 mg twice weekly or 50 mg once weekly
Golimumab:
- 50 mg once a month
Guselkumab:
- 100 mg subcutaneously at week 0 and 4
- Then maintenance dose of 100 mg every 8 weeks thereafter.
- Guselkumab may be used alone or in combination with a conventional DMARD (e.g., methotrexate).
Secukinumab:
- 150 mg SC at weeks 0, 1, 2, and 3
- Followed by monthly maintenance dosing starting at week 4.
- If a patient is an anti-TNFα inadequate responder and continues to have active psoriatic arthritis, consider using the 300 mg SC dose.
- For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis (i.e., 300 mg SC at weeks 0, 1, 2, and 3, followed by monthly maintenance dosing starting at week 4).
Ixekizumab:
- For psoriatic arthritis (PsA) patients or those with PsA and coexistent mild plaque psoriasis:
- 160 mg (two 80 mg injections) SC at Week 0
- Followed by 80 mg every 4 weeks.
- For psoriatic arthritis patients with coexistent moderate-to severe plaque psoriasis:
- 160 mg by subcutaneous injection (two 80 mg injections) at Week 0
- Followed by 80 mg every 2 weeks for 6 doses (i.e., weeks 2, 4, 6, 8, 10, and 12)
- Then 80 mg every 4 weeks thereafter.
- Ixekizumab may be used alone or in combination with a conventional DMARD (e.g., methotrexate).
Upadacitinib:
- Recommended Dose: 15 mg once daily.