DERMATOLOGY SOCIETY OF SOUTH AFRICA

Guidelines

Eligibility Criteria

Biologic Guidelines
To be considered eligible for treatment patients must have:
  1. Severe disease.
    Severe disease is defined as a PASI score of 10 or more (or a BSA of 10% or greater where PASI is applicable.) and a DLQI >10.
    In exceptional circumstances (for example disease affecting high impact sites with associated significant functional or psychological morbidity such as acral psoriasis) patients with severe disease may fall outside this definition but should be considered for treatment.

  2. Failure of standard treatments.
    Patients are regarded as eligible for treatment with biologics where phototherapy and alternative standard systemic therapy have failed, are contraindicated or cannot be used due to the development of, or risk of developing clinically important treatment related toxicity.

    At least 2 standard treatments need to have been tried.

Response failure is defined as < 50% improvement in the PASI score from baseline , or < 5 Points in the DLQI score after at least 3 months of treatment in the recommended therapeutic range of treatment.
  1. Phototherapy. This is regarded as inappropriate ongoing treatment in patients :
    1. Who have exceeded safe exposure limits (150 -200 treatments for PUVA, 350 treatments for narrowband UVB).
    2. Who are non responsive or relapse rapidly.
    3. Who have a history of skin cancer or repeated episodes of severe sunburn
    4. Who are intolerant of UV exposure, especially if skin is Fitzpatrick type 1.
    5. Who For logistical reasons are unable to access light therapy.

  2. Standard systemic drug therapy.
    Standard systemic drug therapy includes:
    1. Cyclosporine (2mg-5mg\Kg) daily for a minimum period of 3 months
    2. Methotrexate 15mg -25 mg weekly either orally or subcutaneously as a single dose for a minimum period of 3 months.
    3. Acitretin (25-50 mg daily) for 3 months.
    Standard drug therapy may be inappropriate if there are contraindications to their use or if the patient has failed to respond adequately. (see above). Such contraindications should be significant and include coexistent or unrelated comorbidities which preclude their use. E.g. chronic renal failure or liver disease.

  3. Severe unstable life threatening disease.
Skin and Joint disease.
If the patient has joint disease as well as skin disease the following eligibility criteria apply.
  1. Defined SARAA (see www.saraa.co.za) criteria and DSSA guideline criteria both apply.
  2. Patients with severe skin psoriasis as well as psoriatic arthritis for whom methotrexate treatment has failed or who cannot use methotrexate will need to be considered for biological therapy considering the benefit of this drug for skin and joint disease.