Axial Involvement in Psoriatic Arthritis cohort (AXIS): the protocol of a joint project of the Assessment of SpondyloArthritis international Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)

Denis Poddubnyy, Xenofon Baraliakos, Filip Van den Bosch, Jürgen Braun, Laura C Coates, Vinod Chandran, Torsten Diekhoff, Floris A van Gaalen, Lianne S Gensler, Niti Goel, Alice B Gottlieb, Désirée van der Heijde, Philip S Helliwell, Kay Geert A Hermann, Deepak Jadon, Robert G Lambert, Walter P Maksymowych, Philip Mease, Peter Nash, Fabian Proft, Mikhail Protopopov, Joachim Sieper, Murat Torgutalp, Dafna D Gladman, Denis Poddubnyy, Xenofon Baraliakos, Filip Van den Bosch, Jürgen Braun, Laura C Coates, Vinod Chandran, Torsten Diekhoff, Floris A van Gaalen, Lianne S Gensler, Niti Goel, Alice B Gottlieb, Désirée van der Heijde, Philip S Helliwell, Kay Geert A Hermann, Deepak Jadon, Robert G Lambert, Walter P Maksymowych, Philip Mease, Peter Nash, Fabian Proft, Mikhail Protopopov, Joachim Sieper, Murat Torgutalp, Dafna D Gladman

Abstract

Background: Involvement of the axial skeleton (sacroiliac joints and spine) is a relatively frequent manifestation associated with psoriatic skin disease, mostly along with involvement of peripheral musculoskeletal structures (peripheral arthritis, enthesitis, dactylitis), which are referred to as psoriatic arthritis (PsA). Data suggest that up to 30% of patients with psoriasis have PsA. Depending on the definition used, the prevalence of axial involvement varies from 25% to 70% of patients with PsA. However, there are currently no widely accepted criteria for axial involvement in PsA.Objective: The overarching aim of the Axial Involvement in Psoriatic Arthritis (AXIS) study is to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research.

Design: Prospective, multicenter, multinational, cross-sectional study.

Methods and analyses: In this multicenter, multinational, cross-sectional study, eligible patients [adult patients diagnosed with PsA and fulfilling Classification Criteria for Psoriatic Arthritis (CASPAR) with musculoskeletal symptom duration of ⩽10 years not treated with biological or targeted synthetic disease-modifying anti-rheumatic drugs] will be recruited prospectively. They will undergo study-related clinical and imaging examinations. Imaging will include radiography and magnetic resonance imaging examinations of sacroiliac joints and spine. Local investigators will evaluate for the presence of axial involvement based on clinical and imaging information which will represent the primary outcome of the study. In addition, imaging will undergo evaluation by central review. Finally, the central clinical committee will determine the presence of axial involvement based on all available information.

Ethics: The study will be performed according to the ethical principles of the Declaration of Helsinki and International Council for Harmonisation Good Clinical Practice guidelines. The study protocol will be approved by the individual Independent Ethics Committee / Institutional Review Board of participating centers. Written informed consent will be obtained from all included patients.Registration: ClinicalTrials.gov ID: NCT04434885.

Keywords: axial spondylitis; psoriatic arthritis; spondyloarthritis.

Conflict of interest statement

Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DP: reports grants and personal fees from AbbVie, Eli Lilly, MSD, Novartis and Pfizer, and personal fees from Bristol Myers Squibb, Roche, UCB, Biocad, GlaxoSmithKline and Gilead. XB: reports grants and personal fees from AbbVie and Novartis, and personal fees BMS, Chugai, Eli Lilly, MSD, Pfizer, UCB, Galapagos and Gilead. FVdB: received speaker and/or consultancy fees from AbbVie, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB. JB: has received honoraria for talks, advisory boards, paid consultancies and grants for studies from Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Fresenius, GlaxoSmithKline, Gilead, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis and UCB. LCC: reports grant/research support from Abbvie, Amgen, Celgene, Lilly, Novartis, Pfizer and honoraria from Abbvie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Galapagos, Gilead, GSK, Janssen, Lilly, Medac, Novartis, Pfizer and UCB. VC: reports honoraria and/or research grants from Abbvie, Amgen, BMS, Eli Lilly, Janssen, Novartis, Pfizer and UCB, and is supported by a Pfizer Chair Rheumatology Research Award from the Department of Medicine, University of Toronto; spouse is an employee of AstraZeneca. TD: reports personal fees from Novartis Pharma, MSD and Canon MS, outside the submitted work. FAvG: reports grants from Stichting vrienden van Sole Mio, Stichting ASAS, UCB and Novartis and honoraria from Novartis, MSD, Abb Vie and Bristol Myers Squibb. LSG: reports grants and personal fees from UCB and Pfizer, and personal fees from AbbVie, Eli Lilly, Janssen and Novartis. NG: Employed by Abcuro, Inc; stockholder UCB. ABG: received honoraria as an advisory board member and consultant for AnaptsysBio, Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb Co., Incyte, GSK, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical Industries, Inc., UCB, Dermavant and Xbiotech. ABG has received research / educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis, UCB, Xbiotech and Sun Pharma. DvdH: reports personal fees from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma, outside the submitted work; and Director of Imaging Rheumatology bv. PSH: received consulting fees (Eli Lilly) and fees for educational services (Pfizer, Novartis, Janssen). KGAH: reports lecture fees from AbbVie, MSD, Pfizer and Novartis. DJ: Although not directly related to this manuscript, DJ has received research grants, educational grants and/or speaker honoraria from AbbVie, Amgen, Biogen, BMS, Celgene, Celltrion, Eli Lilly, Gilead, GSK, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi and UCB. DJ acknowledges that his research time is supported by the NIHR Cambridge Biomedical Research Centre (BRC-1215-42001) and Cambridge Arthritis Research Endeavour (CARE). RGL: has acted as a paid consultant for Calyx, CARE Arthritis, IA Group, Novartis and Pfizer. WPM: is Chief Medical Officer of CARE Arthritis Ltd and has acted as a paid consultant/participated in advisory boards for AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB; received research and/or educational grants from AbbVie, Novartis, Pfizer and UCB; and received speaker fees from AbbVie, Janssen, Novartis, Pfizer and UCB. PM: reports grants and personal fees from AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun and UCB, and personal fees from Boehringer Ingelheim and GlaxoSmithKline. PN: reports consulting / speaker fees from Abbvie, Bristol Myers Squibb, Gilead, Janssen, Novartis, Lilly, Pfizer, Celgene, Roche, Boehringer, Sanofi, Merck, outside the submitted work. FP: reports grants and personal fees from Novartis, Lilly and UCB, and personal fees from AbbVie, AMGEN, BMS, Hexal, MSD, Pfizer and Roche. MP: reports personal fees from Novartis. DDG: Grant support from Abbvie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UBC, and consulting fees from Abbvie, Amgen, BMS, Galapagos, Gilead, Eli Lilly, Janssen, Novartis, Pfizer and UCB. JS: has nothing to disclose. MT: has nothing to disclose.

© The Author(s), 2021.

Figures

Figure 1.
Figure 1.
Study procedures and time line.

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