2016 update of the ASAS-EULAR management recommendations for axial SpondyloArthritis

1. Slide set should, if possible, not exceed 20 Slides 2016 update of the ASAS-EULAR management recommendations for axial SpondyloArthritis

2. Slide 1: Target population/question • Health care professionals taking care of patients with axSpA • Patients to be educated for informedshared decision-making • Pharmaceutical industry, drug agencies, policy makers, health insurance companies

3. Methods/methodical approach • 2 Systematic literature reviews (SLRs) since 2009 • non-pharmacological treatment (Andrea Regel) • pharmacological treatment (Alexandre Sepriano) • SLR on the use of ASDAS vs. BASDAI to define disease activity for the start and continuation of bDMARDs • One-day meeting of the task force • presentation of the findings of the SLRs • rewording of 2010 overarching principles and recommendations • new recommendations formulated • voting on each new overarching principle/recommendation by all task force members in maximal 3 rounds (first round ≥75%, second round ≥67%, third round ≥50%) • After the meeting • Addition of the level of evidence for each recommendation (LoE) and Grade of Recommendation • Addition of level of agreement by the task force members by anonymous voting from 0 (I do notagree at all) to 10 (I fullyagree) (LoA, mean (SD), %≥8)

4. Overarching prinicples • Axial Spondyloarthritis (axSpA) is apotentially severe disease with diverse manifestations, usually requiring multidisciplinary management coordinated by the rheumatologist. • The primary goal of treating the patient with axSpA isto maximize health related quality of lifethrough control of symptoms and inflammation, prevention of progressive structural damage, preservation/normalisation of functionand social participation.

5. Overarching prinicples • The optimal management of patients with axSpArequires a combination of non-pharmacologicaland pharmacological treatment modalities • Treatment of axSpA should aim at the best careand must be based on a shared decisionbetween the patient and the rheumatologist • axSpA incurs high individual, medical and societal costs, all of which should be considered in its managementby the treating rheumatologist

6. Recommendation 1: General treatment • The treatment of patients with axSpAshould be individualised according to the current signs and symptoms of the disease(axial, peripheral, extra-articular manifestations)and the patient characteristics including comorbidities and psychosocial factors.

7. Recommendation 2: Disease monitoring • Disease monitoring of patients with axSpAshould include patient reported outcomes,clinical findings, laboratory tests and imaging,all with the appropriate instrumentsand relevant to the clinical presentation • The frequency of monitoring should be decided on an individual basis depending on symptoms, severity,and treatment

8. Recommendation 3: Treatment target • Treatment should be guidedaccording to a predefined treatment target

9. Recommendation 4: Non-pharmacological therapy • Patients should be educated about axSpAand encouraged to exercise on a regular basisand stop smoking • Physical therapy should be considered

10. Recommendation 5: NSAIDs • Patients suffering from pain and stiffnessshould use an NSAID as first line drug treatmentup to the maximum dose, taking risks and benefitsinto account • For patients who respond well to NSAIDscontinuous use is preferred if symptomatic otherwise

11. Recommendation 6: Analgesics • Analgesics, such as paracetamol and opioid-(like) drugs, might be considered for residual painafter previously recommended treatments have failed,are contraindicated, and/or poorly tolerated

12. Recommendation 7: Corticosteroids • Glucocorticoid injections directed tothe local site of musculoskeletal inflammationmay be considered • Patients with axial disease should not receivelong-term treatment with systemic glucocorticoids

13. Recommendation 8: DMARDs • Patients with purely axial disease should normallynot be treated with csDMARDs • Sulfasalazine may be consideredin patients with peripheral arthritis

14. Recommendation 9: Biological therapy • bDMARDs should be considered in patientswith persistently high disease activity despite conventional treatments (box1) • Current practice is to start with TNFi therapy

15. ASAS-EULAR Recommendations for theTreatment of axSpA Patients with bDMARDs (box 1) Rheumatologist’s diagnosis of axial SpA and Elevated CRP and/or positive MRI and/or Radiographic sacroiliitis and Failure of standard treatment: all patients • at least 2 NSAIDs over 4 weeks (in total) • patients with predominant peripheral manifestations • one local steroid injection if appropriate • normally a therapeutic trial of sulfasalazine and High disease activity: ASDAS ≥ 2.1 or BASDAI ≥ 4 and Positive rheumatologist’s opinion

16. ASAS-EULAR Recommendationsfor the continuation of bDMARDs Consider to continue bDMARDs if after at least 12 weeks of treatment ASDAS improvement ≥ 1.1 or BASDAI improvement ≥ 2 (0-10) Positive rheumatologist‘s opinion to continue and

17. Recommendation 10: TNFi failure • If TNFi therapy fails, switching to another TNFior IL17i therapy should be considered

18. Recommendation 11: bDMARD tapering • If a patient is in sustained remission,tapering of a bDMARD can be considered

19. Recommendation 12: Surgery • Total hip arthroplasty should be consideredin patients with refractory pain or disabilityand radiographic evidence of structural damage, independent of age • Spinal corrective osteotomy in specialised centres may be considered in patients with severe disabling deformity

20. Recommendation 13: Changes in the disease course • If a significant change in the course of the disease occurs, causes other than inflammation, such as a spinal fracture, should be considered and appropriate evaluation, including imaging, should be performed

21. Oxford table

22. Summary of Recommendations • 2016 management recommendations • are better worded as recommendations • integrate the previous management and TNFi-therapy recommendations • cover the entire spectrum of axSpA • emphasize the usefulness of nonpharmacological management • NSAIDs remain the first-line drug • starting of bDMARDs is integrated for patients with radiographic and nonradiographic axSpA • ASDAS as well as BASDAI can be used as disease activity measure • discontinuation of bDMARDs is reworded as continuation • TNFi therapy is the currently preferred bDMARD • after failure of TNFi therapy a switch to either a second TNFi or IL17i therapy is recommended • tapering of bDMARDs is included in the recommendations

23. Summary of Recommendations in Lay format • The new ASAS-EULAR recommendations are applicable to all patients with axial SpondyloArthritis (axSpA). This includes patients with nonradiographic axSpA (normal joints on the pelvis radiograph) and patients with radiographic axSpA (with abnormalities on the pelvis radiographs). • There are five overarching principles dealing with good practice such as • Optimal treatment requires a combination of non-pharmacological and pharmacological treatment modalities • shared decision making • The primary goal of treating the patient with axSpA is to maximize health related quality of life. This should be done by control of symptoms and inflammation, prevention of progressive structural damage, preservation/normalisation of function and social participation. • Thirteen recommendations are formulated • The first three deal with individualised treatment based on current signs and symptoms and patient characteristics; disease monitoring; and the definition of a treatment target. • The next five recommendations describe the use of non-pharmacological treatment, anti-inflammatory painkillers (‘NSAIDs’), painkillers, corticosteroids and other nonbiological antirheumatic drugs. • Only non-pharmacological management and NSAIDs play an important role in the treatment of axSpA.

24. Summary of Recommendations in Lay format • Recommendations 9-11 describe the use of biological antirheumatic drugs. These are prescribed when there is persistent high disease activity despite other treatment. Also the continuation in full dose and possibly tapering is discussed. • The final two recommendations are on surgery and unexpected changes in the disease course.

25. Acknowledgements Victoria Navarro-Compán Salih Özgöcmen Fernando Pimentel dos Santos John Reveille Martin Rudwaleit Percival Sampaio-Barros Jochen Sieper Irene van der Horst-Bruinsma Floris van Gaalen Dieter Wiek (PP) Additionaltask force members Adrian Ciurea Hanne Dagfinrud (HP) Maxime Dougados Pál Géher Robert Inman Merryn Jongkees (PP) UtaKiltz ToreKvien Pedro Machado Helena Marzo-Ortega Anna Moltó Steering committee Désirée van der Heijde (convenor) Jürgen Braun (co-convenor) Sofia Ramiro (methodologist) AlexandreSepriano (fellow) Andrea Regel (fellow) XenofonBaraliakos Robert Landewé Filip van den Bosch