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Introduction: This post hoc analysis of phase 2 trial data assessed the efficacy of tofacitinib on magnetic resonance imaging (MRI) outcomes with the detailed anatomy-based Canada–Denmark (CANDEN) MRI scoring system and evaluated tofacitinib suppression of spinal inflammation in patients with active ankylosing spondylitis (AS). Methods: Patients with active AS (per modified New York criteria) were randomized 1:1:1:1 to receive tofacitinib 2, 5, or 10 mg twice daily (BID), or placebo, in a 16-week, phase 2, double-blind clinical trial. Spine MRI assessments were performed at baseline and week 12. For post hoc analysis, MRI images from patients receiving tofacitinib 5 or 10 mg BID, or placebo, were re-evaluated by two readers blinded to time point/treatment and assessed by the CANDEN MRI scoring system. Least squares mean changes from baseline to week 12 were reported for CANDEN-specific MRI outcomes, with analysis of covariance used for comparisons of pooled tofacitinib and tofacitinib 5 or 10 mg BID versus placebo. p values without multiplicity adjustment were reported. Results: MRI data from 137 patients were analyzed. At week 12, CANDEN spine inflammation score and vertebral body, posterior elements, corner, non-corner, facet joint, and posterolateral inflammation subscores were significantly reduced with pooled tofacitinib versus placebo (p < 0.0001; except non-corner subscore, p < 0.05). Total spine fat score was numerically increased with pooled tofacitinib versus placebo. Conclusions: In patients with AS, tofacitinib treatment was associated with significant reductions in MRI scores of spinal inflammation versus placebo, as assessed by the CANDEN MRI scoring system. Tofacitinib reduced inflammation in posterolateral elements of the spine and facet joints, which has not been described previously. Trial Registration: ClinicalTrials.gov registry (NCT01786668).

Objectives: To define the instruments for the ASAS-OMERACT core domain set for axial spondyloarthritis (axSpA). Methods: An international working group representing key stakeholders selected the core outcome instruments following a predefined process: i) Identifying candidate instruments using a systematic literature review; ii) Reducing the list of candidate instruments by the working group, iii) Assessing the instruments’ psychometric properties following OMERACT Filter 2.2, iv) Selection of the core instruments by the working group; v) Voting and endorsement by ASAS. Results: The updated core set for axSpA includes seven instruments for six domains that are mandatory for all trials: ASDAS and NRS patient global assessment of disease activity; NRS total back pain; average NRS of duration and severity of morning stiffness; NRS fatigue; BASFI; and ASAS health index. There are 9 additional instruments considered mandatory for disease modifying drugs (DMARDs) trials: MRI activity SPARCC sacroiliac joints and SPARCC spine, uveitis, IBD and psoriasis assessed as recommended by ASAS, 44 swollen joint count, MASES, dactylitis count, and mSASSS. The imaging outcomes are considered mandatory to be included in at least one trial for a drug tested for DMARD-properties. Furthermore, 11 additional instruments were also endorsed by ASAS to be used in axSpA trials on top of the core instruments. Conclusions: The previous core instrument set has been updated and endorsed for the use in all axSpA trials. The selection of the instruments for the ASAS-OMERACT core domain set complete the update of the core outcome set for axSpA.

Background: The current core outcome set for ankylosing spondylitis (AS) has had only minor adaptations since its development 20 years ago. Considering the significant advances in this field during the preceding decades, an update of this core set is necessary. Objective: To update the ASAS-OMERACT core outcome set for AS into the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA). Methods: Following OMERACT and COMET guidelines, an international working group representing key stakeholders (patients, rheumatologists, health professionals, pharmaceutical industry and drug regulatory agency representatives) defined the core domain set for axSpA. The development process consisted of: i) Identifying candidate domains using a systematic literature review and qualitative studies; ii) Selection of the most relevant domains for different stakeholders through a 3-round Delphi survey involving axSpA patients and axSpA experts; iii) Consensus and voting by ASAS; iv) Endorsement by OMERACT. Two settings are considered based on the type of therapy investigated in the trial: symptom modifying therapies and disease modifying therapies. Results: The updated core outcome set for axSpA includes 7 mandatory domains for all trials (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events including death). There are 3 additional domains (extra-musculoskeletal manifestations, peripheral manifestations and structural damage) that are mandatory for disease modifying therapies and important but optional for symptom modifying therapies. Finally, 3 other domains (spinal mobility, sleep, and work and employment) are defined as important but optional domains for all trials. Conclusion: The ASAS-OMERACT core domain set for AS has been updated into the ASAS-OMERACT core domain set for axSpA. The next step is the selection of instruments for each domain.

Peter C Taylor, 1 Neil Betteridge, 2 T Michelle Brown, 3 John Woolcott, 4 Alan J Kivitz, 5 Cristiano Zerbini, 6 Diane Whalley, 7 Oyebimpe Olayinka-Amao, 3 Connie Chen, 8 Palle Dahl, 9 Dario Ponce de Leon, 10 David Gruben, 11 Lara Fallon 12 1Botnar Research Centre, University of Oxford, Oxford, UK; 2Neil Betteridge Associates, London, UK; 3Patient-Centered Outcomes Assessment Group, RTI Health Solutions, Research Triangle Park, NC, USA; 4Patient and Health Impact, Health Economics and Outcomes Research, Pfizer Inc, Collegeville, PA, USA; 5Altoona Center for Clinical Research, Duncansville, PA, USA; 6Department of Rheumatology, Centro Paulista De Investigação Clinica, São Paulo, Brazil; 7Patient-Centered Outcomes Assessment Group, RTI Health Solutions, Manchester, UK; 8Xeljanz, Rheumatology, Inflammation & Immunology Medical Affairs, Pfizer Inc, New York, NY, USA; 9Medical Affairs, International Developed Markets, Inflammation & Immunology, Pfizer Inc, Ballerup, Denmark; 10Medical Affairs Latin-America, Pfizer Inc, New York, NY, USA; 11Statistical Research and Data Science Center, Pfizer Inc, Groton, CT, USA; 12Global Medical Affairs, Pfizer Inc, Montreal, QC, CanadaCorrespondence: Peter C TaylorBotnar Research Centre, University of Oxford, Windmill Road, Headington, Oxford OX3 7LD, UKTel +441865 227323Email peter.taylor@kennedy.ox.ac.ukPurpose: Current knowledge of the reasons for patients’ preference for rheumatoid arthritis (RA) treatment modes is limited. This study was designed to identify preferences for four treatment modes, and to obtain in-depth information on the reasons for these preferences.Patients and Methods: In this multi-national, cross-sectional, qualitative study, in-depth interviews were conducted with adult patients with RA in the United States, France, Germany, Italy, Spain, Switzerland, the United Kingdom, and Brazil. Patients’ strength of preference was evaluated using a 100-p