Position statements

Guidelines for the use of Anti-Tumour Necrosis Factor agents in the management of patients suffering from Ankylosing Spondylitis

The following guidelines have been drawn by the SOUTH AFRICAN RHEUMATISM AND ARTHRTIS ASSOCIATION. They are based on the consensus statement published in the ANNALS OF THE RHEUMATIC DISEASES: 62:817-824. It is emphasized that these guidelines should be used for guidance in clinical decision-making; they should not be seen as totally restrictive criteria. These agents should not be used by clinicians unfamiliar with their use.

PATIENT SELECTION

Patients normally fulfilling modified New York criteria for definitive AS
adiological criteria
≥Grade 2, bilateral Sacroiliitis, or grade 2 to 4 unilateral sacroiliitis
Clinical criteria
Low back pain and stiffness for >3 months, that improves with exercise but is not relieved by rest.
Limitation of motion of the lumbar spine in both sagittal and frontal planes.
Limitation of chest expansion relative to normal values correlated for age and sex.

ACTIVE DISEASE

Active disease for >4 weeks
BASDAI >4 (0-10) and an expert opinion that anti-TNF treatment should be started.

TREATMENT FAILURE

All patients must have had an adequate therapeutic trial of at least 2 NSAIDs.
A therapeutic trial is defined as:
  • Treatment for 3 months at maximal recommended doses or tolerated doses unless contra-indicated.
  • Treatments for ≤3 months were treatment was withdrawn because of intolerance, toxicity or contraindications
Patients with symptomatic peripheral arthritis (normally having a lack of response to a local steroid injection for those with oligoarticular involvement) must have had a therapeutic trial of NSAIDs, Sulphasalazine and Methotrexate, singly or in combination at adequate therapeutic doses. A therapeutic dose of Sulphasalazine is considered to be at least 2grams daily and for Methotrexate, at least 15mg/week. Intolerance to either or both of these agents should be considered a treatment failure. Patients with symptomatic enthesitis must have had an adequate therapeutic trial of at least two local steroid injections unless contraindicated.

CONTRAINDICATIONS


Pregnancy and breastfeeding, adequate contraception must be practiced.
Active infection
Patients at high risk of infection, including:
  • Chronic leg ulcer
  • Previous Tuberculosis (See SARAA guidelines)
  • Septic arthritis of a native joint within the past 12 months
  • Sepsis of a prosthetic joint within the last 12 months or indefinitely if the prosthesis remains in-situ.
  • Persistent or recurrent chest infection.
  • Indwelling urinary catheter.
  • History of Lupus or Multiple Sclerosis
  • Malignancy or premalignant states, excluding:
    • Basal cell Carcinoma
    • Malignancy diagnosed and treated more than 10 years previously where the probability of total cure is very high).
Assessment of response

BASDAI: 50% relative change or absolute change of 2 (scale 0-10) and an expert opinion as to whether treatment is to continue or not.
Evaluation should be made between six and twelve weeks. (BASDAI may be obtained from www.spondylitis.org)

Dosage

Recommended dosage is Revellex (Infliximab) 5mg/kg. Dose interval is recommended at 8 weeks. The initial dose may be followed by two further loading doses at two weeks and at four weeks after initiation and thereafter continued at eight weekly intervals. A sub therapeutic response after six weeks should be considered a treatment failure. Enbrel (Etanercept) 25mg SC twice weekly is also registered for the management of Ankylosing spondylitis. Re-evaluation should be performed after six weeks of therapy