Biologic agents for ankylosing spondylitis – policy criteria
In 2008, the international ASAS (assessment in ankylosing spondylitis) working group has updated recommendations for the use of anti-TNF agents in ankylosing spondylitis (AS). The latest consensus notes the following criteria for initiation of anti-TNF agents:
•diagnosis of definitive AS
•active disease for at least 4 weeks, as defined by the sustained Bath AS disease activity index (BASDAI) of ≥4 on a 0–10 scale and expert opinion based on clinical findings
•refractory disease, defined by failure of: at least two NSAIDs for at least 3 months (for all patients), at least one local steroid injection (only for patients with symptomatic peripheral arthritis), and sulfasalazine (specifically for patients with predominantly peripheral arthritis). For patients with pure axial manifestations, DMARD failure is not required prior to the initiation of anti-TNF agents
For monitoring anti-TNF treatment:
•both the ASAS core set for clinical practice and the BASDAI should be followed after the initiation of treatment
•discontinuation in non-responders should be considered after 6–12 weeks of treatment initiation
In addition, in December 2008, another international group of rheumatologists and bioscientists published a consensus statement on the use of biologic agents in rheumatologic diseases, including ankylosing spondylitis (AS). ASAS recommendations were endorsed and according to this statement no one anti-TNF agent is preferred. Also, it was stated that clinical improvement usually occurs in 12-16 weeks and in open-label studies efficacy persisted for 2-5 years.
The National Institute for Health and Clinical Excellence (NICE) in the UK recently published a technology appraisal in 5/08, positioning Enbrel or Humira after at least 2 assessments of spinal disease (12 weeks apart) along with failure of at least 2 NSAIDs. These guidelines do not recommend Remicade for the treatment of AS.
In our analysis of 6 local and national plans, only 2/6 plans require failure/intolerance/contraindication of an NSAID +/- DMARD/corticosteroid for any anti-TNF agent; most plans require prior failure of either an NSAID or a DMARD.
Braun J et al. First update of the international ASAS consensus statement for the use of anti-TNF agents in patients with ankylosing spondylitis. Ann Rheum Dis. 2006;65(3):316-20. Pubmed abstract
Furst DE et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2008. Ann Rheum Dis. 2008;67 Suppl 3:iii2-25.