GUIDELINES - First international recommendations for ankylosing spondylitis

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First international recommendations for ankylosing spondylitis

Rheumawire

March 31, 2006

Zosia Chustecka

Herne, Germany - New evidence-based recommendations for the management of

ankylosing spondylitis (AS) have been drawn up by the international

Assessment in AS (ASAS) working group in collaboration with the European

League Against Rheumatism (EULAR). These recommendations are the first to be

developed internationally for AS, the experts comment in the April 2006

issue of the ls of Rheumatic Disease [1].

Prompted by the dramatic history of successful approvals of TNF inhibitors

for this disease over the past three years, the document puts these new

therapies into context alongside other drugs and nonpharmacological

interventions. " The recommendations reflect expert opinion based on the

current research evidence, " the authors comment. The literature review

forming the evidence base is detailed in a separate paper in the same issue

[2]. The experts promise that the document " will be updated regularly, to

keep abreast of new developments. " They also emphasize that it consists of

recommendations and not guidelines and comment that " the final proposals

were a synthesis of quite marked variations in opinion. "

Ten recommendations are proposed; the first three deal with general concepts

in the management of the disease, and the remaining seven describe specific

treatments, focusing on the effect they have on the treatment of pain and

function. Optimal management requires a combination of pharmacological and

nonpharmacological treatments, the experts write. Nondrug interventions

should include patient education and regular exercise, and physical therapy

and self-help groups may also be useful.

First-line drug treatment consists of nonsteroidal anti-inflammatory drugs

(NSAIDs). Comparative studies have not shown any one preparation to be

better than others. For patients with an increased GI risk, a nonselective

NSAID with a gastroprotective agent or a selective COX-2 inhibitor could be

used. A recent study [3] with celecoxib (Celebrex, Pfizer) in AS comparing

intermittent " on-demand " use with continuous use suggests that continuous

use retards radiographic disease progression at two years, a finding that

" warrants further investigation. " In general, the choice of drug should be

based on the GI risk profile of the patient but should also take into

account concomitant risk factors for cardiovascular disease, the experts

comment. In patients who can't take NSAIDs or who need further pain relief,

analgesics such as acetaminophen/paracetamol and opioids might be

considered, the experts comment, although they point out that these have not

been prospectively studied in AS.

Local injections of corticosteroids to the site of inflammation may be

considered, but the use of systemic corticosteroids in axial disease is not

supported by evidence. Intra-articular or periarticular injections of

corticosteroids have shown efficacy for the pain of sacroiliitis in a small

clinical trial, the document notes. No studies have examined corticosteroid

injections for enthesitis or for peripheral arthritis in AS patients, but

the expert group feels that these " can be helpful in selected cases. "

Potential toxicity, including tendon rupture, must be considered, they add.

Disease modifying ant-rheumatic drugs (DMARDs), including methotrexate and

sulfasalazine, are not effective in axial disease, but sulfasalazine may be

considered in patients with peripheral arthritis. Although the evidence for

the efficacy of sulfasalazine in AS is inconclusive, long-term trials

generally support an effect on peripheral joints but not spinal

inflammation, especially not in patients with longer disease duration, the

experts comment. Toxicity is common but usually mild and includes GI

symptoms, mucocutaneous manifestations, and hepatic enzyme and hematological

abnormities. Open trials have suggested a benefit of thalidomide on spinal

disease, but toxicity is substantial, and the experts conclude that it

outweighs any potential therapeutic benefit.

TNF-inhibitor therapy should be given to patients with persistently high

disease activity despite conventional treatments. There is no evidence to

support obligatory use of DMARDs before the use of TNF inhibitors or their

concomitant use in patients with axial disease. Evidence from randomized

clinical trials supports the use of etanercept (Enbrel, Amgen/Wyeth) and

infliximab (Remicade, Centocor), and one study supports adalimumab (Humira,

Abbott), the most recent of these products. Effect size is large, and the

number needed to treat (NNT) is low, the experts comment (for all anti-TNF

products, NNT=2.6 [95% CI 2.2-3.0]). The onset of clinical effect is rapid,

and the therapeutic effect persists for up to three years with continuing

treatment. Stopping treatment results in a high rate of clinical relapse.

" Although significantly more expensive than traditional AS treatments, the

large improvements in pain and function with TNF-blocker treatment may well

outweigh the high costs in a formal cost/benefit analysis, projecting over

30 years that such treatments are even more cost-effective when function and

therefore productivity are preserved, " they comment.

The document also covers surgical interventions. Hip replacement should be

considered in patients with refractory pain or disability and with

radiographic evidence of structural damage, independent of age. Spinal

surgery may be of value in selected patients, the experts comment. Closing

wedge lumbar osteotomy for fixed kyphotic deformity causing major disability

can give excellent functional results by restoring balance and horizontal

vision. Fusion procedures should be considered in patients with segmental

instability as a result of spinal pseudoarthrosis or Andersson lesion and in

cases of instability or intractable pain due to spinal fracture.

Sources

1. Zochling J, van der Heijde D, Burgos-Vargas R, et al.

ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann

Rheum Dis 2006; 65:442-452.

2. Zochling J, van der Heijde, Dougados M, Braun J. Current

evidence for the management of ankylosing spondylitis: a systemic literature

review for the ASAS/EULAR management recommendations in ankylosing

spondylitis. Ann Rheum Dis 2006; 65:423-432.

3. Wanders A, van der Heijde D, Landewe R, et al.

Nonsteroidal anti-inflammatory drugs reduce radiographic progression in

patients with ankylosing spondylitis. Arthritis Rheum 2005; 52:1756-1765.

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