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ACR Cautions Against Mandated Biosimilar Switching for AS, axSpA
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Adults with active ankylosing spondylitis despite treatment with a first TNF-inhibitor, as well as those with stable disease receiving an originator TNF inhibitor, should not be switched to a biosimilar, according to updated recommendations from the American College of Rheumatology published in Arthritis Care & Research.
The 2019 updated recommendations, intended for the treatment of patients with AS and nonradiographic axial spondyloarthritis, were developed by the ACR in partnership with the Spondylitis Association of America (SAA) and the Spondyloarthritis Research and Treatment Network (SPARTAN). In addition to biosimilars, the new recommendations provide updated information on managing biologics, as well as disease assessment, imaging and screening.
“Based on the literature, we felt it was important to address topics such as sequencing biologics for patients with active AS despite NSAID usage, whether to taper or discontinue biologics in the setting of remission and clearer guidelines on when to obtain images — particularly in instances when results would likely lead to a change in treatment,” Michael Ward, MD, MPH, of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said in a press release. “We hope this new information will help get patients on an effective treatment faster and ultimately improve patients’ health status and quality of life.”
To update the 2015 ACR treatment guideline, Ward and colleagues conducted a systematic literature review for 20 clinical questions on pharmacological treatment from the original recommendations, in addition to 26 new questions related to pharmacological treatment, treat-to-target strategies and the use of imaging. Results of the literature review were then discussed by a separate voting panel and subsequently developed into recommendations, with each categorized as “conditional” or “strong” based on the strength of the available evidence.
The ACR currently uses the Grading Recommendations Assessment, Development and Evaluation (GRADE) methodology to craft recommendations. According to the ACR press release, the limited data in some research areas meant that the quality of the available evidence was often low, very low or, occasionally, moderate. For this reason, nearly all of the updated recommendations for the treatment of AS and nonradiographic axial SpA have been labeled “conditional,” with only a few “strong” items for which there was sufficient evidence.
The 2019 update features a total of 86 recommendations, four of which cover the potential use of biosimilars for AS or nonradiographic axial SpA. For adults with either active AS or active nonradiographic axial SpA, despite treatment with their first TNF inhibitor, the ACR strongly recommends against switching to a biosimilar. In addition, for adults with either stable AS or nonradiographic axial SpA who are receiving an originator TNF inhibitor, the recommendations strongly urge against mandated switching to a biosimilar.
Other recommendations from the guideline include:
- A strong recommendation to treat adults with active AS – despite the use of NSAIDs – with a TNF inhibitor, rather than not treating with a TNF inhibitor.
- A conditional recommendation to treat patients with a TNF inhibitor rather than with secukinumab (Cosentyx, Novartis), ixekizumab (Taltz, Eli Lilly) or tofacitinib (Xeljanz, Pfizer).
- A conditional recommendation to treat with seukinumab or ixekizumab over tofacitinib.
- A conditional recommendation against repeat spine radiographs at scheduled intervals as a standard approach for adults with active or stable nonradiographic axial SpA.
“New questions on the treatment of patients with stable disease were addressed in this update,” Ward and colleagues wrote. “Discontinuation of biologics is not recommended due to the likelihood for symptom recurrence. If tapering is considered, patients should be counseled regarding the potential for increased disease activity. Co-treatment with low-dose methotrexate is not generally recommended, but ongoing studies will shed further light on this question. Switching to a biosimilar during the course of treatment with TNF inhibitor is also not recommended, echoing the concerns previously expressed by the ACR.” – by Jason Laday
Disclosure: Ward reports funding from the NIH. Please see the full study for additional disclosures.
Perspective
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David A. McLain, MD, FACP, FACR
This first thing you will notice about these newly issued guidelines for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis is the disclaimer that these guidelines are “not to dictate the care of a particular patient.” This is an important disclaimer as our treatment decisions are often challenged as not complying with guidelines which have been converted to ‘laws’ by pharmacy benefit managers.
The panel for the guidelines graded the quality of scientific evidence for the recommendations. Surprisingly, most of the recommendations have a “low” or “very low” level of scientific support. The guidelines strongly recommend a TNF inhibitor in those patients with an inadequate response to NSAIDs. Among those who fail to respond to the first TNF inhibitor, the panel conditionally recommends the use of secukinumab (Cosentyx, Novartis) or ixekizumab (Taltz, Lilly) over the use of a second TNF inhibitor. They grade the scientific support for this as “very low”.
The use of sulfasalazine, methotrexate or tofacitinib (Xeljanz, Pfizer) was conditionally recommended over no treatment with these medications, mainly for prominent peripheral arthritis or when TNF inhibitors were not available. Patients in our clinics on Medicare Advantage plans or those without insurance — due to cost considerations — are often placed on generic medications like sulfasalazine or methotrexate. The committee felt the recommendations for AS and SpA (nonradiographic) were similar.
The committee further recommended that NSAIDs should be taken “on demand” vs. continuously, and that it was preferred to take a continuous TNF inhibitor alone vs. TNF inhibitor and NSAID or discontinuing the TNF inhibitor.
In general, these guidelines are helpful to support the use of TNF inhibitors and the secondary agents of secukinumab and ixekizumab in AS and SpA with PBMs and insurance carriers. The “low” or “very low” level of evidence that exist for most recommendations underscores the need for more studies, although many studies — such as head-to-head trials with the various agents — are probably too costly to ever be done.
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