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VIDEO: Updated axial SpA recommendations include IL-17 inhibitors

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IL-17 inhibitors represent a step forward

It’s important to have updated treatment recommendations as we accrue new evidence and treatment options. These recommendations can now address interleukin-17 inhibitors, which were not available for U.S. use to treat ankylosing spondylitis when the American College of Rheumatology and its collaborating organizations released updated recommendations for treating ankylosing spondylitis and nonradiographic axial spondyloarthritis in September 2015 (Arthritis Rheum. 2016 Feb;68[2]:282-98). Having interleukin (IL)-17 inhibitors now available and joining tumor necrosis factor (TNF) inhibitors as a second class of biological drugs to treat these patients is a big step forward.

I do not believe strong evidence exists to make IL-17 inhibitors second-line agents behind TNF inhibitors as was done in the new European recommendations. That was an expert-opinion based decision rather than something based on clear evidence.

Another notable feature of the updated European recommendations is that they anchor several treatment decisions to measuring a patient’s disease activity and comparing the level of activity against defined thresholds. This is very different from the approach generally used in U.S. practice, where we do not require patients to have a certain level of quantifiable disease activity to either initiate or stop treatment. In U.S. practice, the rheumatologist’s assessment of disease activity is what matters, however that is done.

The European recommendations also call specifically for considering tapering down a biological drug once a patient achieves remission of active disease. In my experience, when a patient achieves remission it is more often the nonsteroidal anti-inflammatory drug that rheumatologists prefer to taper because they attribute the patient’s good response primarily to his/her biological treatment. And the evidence is good that when a patient with ankylosing spondylitis stops treatment with a TNF inhibitor his/her disease tends to reactivate.

During the near future, we can expect an increased focus on diagnosing patients with axial spondyloarthritis and ankylosing spondylitis earlier and starting treatment earlier. I expect that this could lead to improved patient outcomes. I also expect that we will soon see more evidence regarding the effect of drug treatment on extra-articular manifestations of these diseases, and that this evidence will help dictate the specific treatments we choose for each patient. In the future, we will administer more personalized management for these disorders that is better tailored to each individual patient.

Dr. Lianne S. Gensler is a rheumatologist and director of the Ankylosing Spondylitis Clinic at the University of California, San Francisco. She has been a consultant to or has received research support from Abbvie, Amgen, Janssen, Novartis, and UCB. She made these comments in an interview.


 

AT THE EULAR 2016 CONGRESS

References

LONDON – The option of treating axial spondyloarthritis with an interleukin-17 inhibitor has become an officially recommended option for the first time in a new update to management recommendations for this disease released by a task force assembled jointly by the Assessment of SpondyloArthritis International Society and the European League Against Rheumatism.

The update replaces recommendations last released by the two groups for managing patients with ankylosing spondylitis in 2010 (Ann Rheum Dis. 2011 June;70[6]:896-904), as well as the prior recommendations from the two organizations for using tumor necrosis factor (TNF) inhibitors on these patients (Ann Rheum Dis. 2011 June;70[6]:905-8). The new update also broadens the disease spectrum from ankylosing spondylitis to axial spondyloarthritis (SpA).

Dr. Désirée van der Heijde Mitchel L. Zoler/Frontline Medical News

Dr. Désirée van der Heijde

The latest recommendations continue to place nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacotherapy for patients with axial SpA to control pain and stiffness, and continue to place treatment with a biological disease modifying antirheumatic drug (DMARD) – identified in the recommendations as most typically a TNF inhibitor by current practice – as second-line treatment after NSAIDs. The recommendations specify that initiation of a biological DMARD should target patients who have both failed treatment with at least two different NSAIDs over the course of at least 4 weeks of treatment, and who have active disease documented by either of two standard measures of disease activity in patients with axial SpA: either a score of at least 2.1 on the ankylosing spondylitis disease activity score (ASDAS) or a score of at least 4 on the Bath ankylosing spondylitis disease activity index (BASDAI).

Incorporation of the ASDAS as a potential alternative to the BASDAI for assessing disease activity in these patients is another new feature of these recommendations, noted Dr. Désirée van der Heijde, convenor of the update task force, who presented the new recommendations at the European Congress of Rheumatology.

The new recommendations place use of an interleukin (IL)-17 inhibitor as a third-line management option, for patients who fail to adequately respond to a first TNF inhibitor, and they also say that an alternative to starting an IL-17 inhibitor at this stage of management is to instead try treatment with a second type of TNF inhibitor. The IL-17 inhibitor class includes secukinumab (Cosentyx), which received approval from the Food and Drug Administration for treating active ankylosing spondylitis in January 2016, and which also has approval for the same indication from the European Medicines Agency.

The updated recommendations leave unchanged from the prior version advice to use biological DMARDs only after failure of other treatments, as well as advocacy of nondrug therapy with regular exercise, smoking cessation, and physical therapy when appropriate as the very first therapeutic step to take, before even starting a NSAID regimen. For patients with axial SpA who have peripheral arthritis, the recommendations say that clinicians can consider treatment with a local injection of a glucocorticoid, and a treatment course with sulfasalazine. The recommendations do not endorse treatment with a conventional, synthetic DMARD for patients with purely axial disease, and they also recommend against long-term treatment with a systemic corticosteroid. The update calls analgesics contraindicated.

Another new feature of the updated recommendations is endorsement of treating axial SpA patients to a predefined treatment target, although the recommendations left the nature of that target undefined and is something for the treating clinician to discuss and tailor to each patient individually, said Dr. van der Heijde, professor of rheumatology at Leiden University Medical Center in The Netherlands. The update also introduces for the first time the recommendation to consider tapering down treatment with a biological DMARD for patients who achieve remission.

Dr. van der Heijde said that she has been a consultant to 17 drug companies.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

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