“When you arrive at a diagnosis of non-radiographic axial spondyloarthritis (nr-axSpA), there’s a sense of relief that on one hand you have found the source of your patient’s symptoms. However until recently, we’ve had no specific subsidised treatments. Now we have access to a PBS-listed TNF-inhibitor for patients with nr-axSpA.¹

What we’re hoping to see is modulation of the disease activity so that patients feel improvement in their symptoms and we eagerly await further data to determine if we change the course of this chronic disease,” begins Professor Paul Bird, Rheumatologist, Chair of the International Magnetic Resonance Imaging Research Association and Director of Optimus Clinical Research. In the third of our series on nr-axSpA, the limbic spoke with Prof. Bird about how the management of nr-axSpA is changing and the ideal, multidisciplinary treatment pathway.

PBS listing of golimumab a relief for patients and rheumatologists

For around 30,000 Australians, the PBS listing of golimumab for nr-axSpA offers a disease-modifying treatment option that has never before been on the table.² “For years I think we’ve been fighting the perception that there’s not much that can be done if we can’t see damage on an X-ray.. A diagnosis of nr-axSpA was more a watch and wait game, waiting to see if radiographic evidence of disease appeared (as AS is not a given progression for all patients) and in the mean time prescribing non-steroidal anti-inflammatories and exercise to relieve the symptoms and preserve function.^3,4 The December PBS listing of the TNF-inhibitor golimumab is a relief for patients and the healthcare providers managing them.” notes Prof. Bird. “We can finally give them something to help their symptoms, and we hope much more,” he adds.

For years, studies comparing nr-axSpA with AS have found no differences in disease activity (as assessed by the Bath AS disease activity index (BASDAI), total pain and patient’s global assessment of disease) and similar levels of pain reported by patients with each.⁵ Yet until now, the only treatments available to patients without radiographic evidence of structural changes were non-steroidal anti-inflammatory drugs (NSAIDs) and exercise therapy.^6,7 Now, although NSAIDs remain the front-line therapy, for those patients who have failed to achieve an adequate response following treatment with at least two NSAIDs and met the additional criteria, golimumab is available.¹

“NSAIDs and exercise have been effective for managing symptoms to a degree, but there comes a point where its just not enough. We want to keep the pain at bay so patients can move and sleep well. We see the inflammation using magnetic resonance imaging (MRI) and until now had nothing to really modify that disease process. Steroids have not proven useful and other disease-modifying anti-rheumatic drugs show little effect on the axial symptoms of the disease.^4,8 Although the evidence for TNF-inhibitors have been building for a while, we’ve not been able to use them until now due to lack of re-imbursement,”⁷ remarks Prof. Bird.

In light of golimumab gaining approval in several markets, the American College of Rheumatology is currently updating its guideline recommendations on the management of axial spondylitis.⁹ The 2019 ACR/SAA/SPARTAN Updated Recommendations for the Management of Axial Spondyloarthritis (final publication anticipated in 2019) is expected to build upon the 2016 conditional recommendation where patients with active nr-axSpA despite treatment with NSAIDs were recommended to be treated with a TNF inhibitor.^4,9 Similarly, the Assessment of SpondyloArthritis international Society (ASAS)/European League Against Rheumatism (EULAR) 2017 guidelines notes a central role of NSAIDs as a first-line treatment for axial spondyloarthritis, and recommends biologics such as TNF-inhibitors for patients with high disease activity despite NSAID use (or intolerance/contraindication).⁸ Central to the assessment of high disease activity is an elevated C-reactive protein and/or definite inflammation on magnetic resonance imaging (MRI).⁸

Initial treatment PBS criteria for golimumab in adults with nr-axSpA

Clinical criteria:¹

• Patient must not have received PBS-subsidised treatment with this drug for this condition in the last 5 years or more, AND
• Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest, AND
• Patient must have failed to achieve an adequate response following treatment with at least 2 NSAIDs (BASDAI ≥ 4, CRP > 10 mg/L), whilst completing an appropriate exercise program, for a total period of 3 months, AND
• Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27), AND
• The condition must not be radiographically evidenced on plain X-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis, AND
• The condition must be nr-axSpA, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria, AND
• The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI), AND
• The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent), AND
• The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium), AND
• The treatment must not exceed a maximum of 16 weeks with this drug under this restriction.

Treatment criteria:¹

Must be treated by a rheumatologist; OR clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.

A joint effort is the way forward

“Of course, all the other things we do to manage these patients still stands – an individualised approach that works towards a common goal that we and our patients set together.¹⁰ Exercise has already played an important role in the management of our patients with AS, and continues to be important for those with nr-axSpA. The goal is really to maximise long-term health-related quality of life and to prevent structural damage which we know limits patient movement and function even more,”⁷ adds Prof. Bird. He continues, “other health professionals play a key part in the delivery of care for these patients.⁷ In my practice that has included nurses, physiotherapists, and exercise physiologists.”

What’s more, guidelines like ASAS/EULAR have moved towards not only goal-oriented treatment, but disease monitoring that includes patient-reported outcomes as well.⁸ Disease monitoring is recommended to extend beyond clinical, laboratory and imaging findings, with the patient experience taken into account using appropriate instruments relevant to their clinical presentation.⁸ “Indeed, as nr-axSpA can be heterogeneous in its presentation and features – particularly when it comes to extra-articular disease. Designing a treatment plan around each patient’s individual needs means that a great variety of other healthcare professionals may be involved in the patient’s care. Rheumatologists and rheumatology nurses often are ideal to be at the centre of that care and help connect patients with the services and care they need,” adds Prof. Bird.

He concludes, “I expect this new development will not only help us better manage the symptoms of nr-axSpA, it will help us understand even more about the course of the disease. And it provides an opportunity for us to lead the way when it comes to including patient-reported outcomes in outcome assessment..”

This article was sponsored by Janssen, which has no control over editorial content. The content is entirely independent and based on published studies and experts’ opinions, the views expressed are not necessarily those of Janssen.

References:

1. Australian Government. Department of Health. Pharmaceutical Benefits Scheme. Available at: pbs.gov.au (accessed 12 February 2019).
2. Arthritis Australia. Non-radiographic axial spondyloarthritis. Available at: https://arthritisaustralia.com.au/types-of-arthritis/non-radiographic-axial-spondyloarthritis/ (accessed 12 February 2019).
3. Ghosh N, Ruderman EM. Arth Res Ther 2017;19:286.
4. Ward MM, et al. Arth Rheumatol 2016; 68(2):282-298.
5. Baraliakos X, et al. RMD Open 2015;1(Suppl 1):e000053.
6. Kroon FPB, et al. Cochr Datab Syst Rev 2015;Issue 7. Art. No.:CD010952.
7. Brown M, Bradbury LA. Med J Aust 2017;206(5):192-194e1.
8. Van der Heijde D, et al. Ann Rheum Dis 2017;76:978-991.
9. American College of Rheumatology. Axial spondyloarthritis. Available at: https://www.rheumatology.org/Practice-Quality/Clinical-Support/Clinical-Practice-Guidelines/Axial-Spondyloarthritis (accessed 12 February 2019).