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Research ArticleAccepted Articles

One-third of European axial spondyloarthritis patients reach pain"remission" with routine care TNF-inhibitor treatment

Lykke Midtbøll Ørnbjerg, Kathrine Rugbjerg, Stylianos Georgiadis, Simon Horskjær, Lykke Midtbøll Ørnbjerg, Kathrine Rugbjerg, Stylianos Georgiadis, Simon Horskjær Rasmussen, Ulf Lindström, Karel Pavelka, Neslihan Yilmaz, Ennio Giulio Favalli, Michael J. Nissen, Brigitte Michelsen, Elsa Vieira-Sousa, Gareth T. Jones, Ruxandra Ionescu, Heikki Relas, Carlos Sanchez-Piedra, Matija Tomšič, Arni Jon Geirsson, Irene van der Horst-Bruinsma, Johan Askling, Anne Gitte Loft, Lucie Nekvindova, Haner Direskeneli, Florenzo Iannone, Karen Minde Fagerli, Maria José Santos, Gary J. Macfarlane, Catalin Codreanu, Kari Eklund, Manuel Pombo-Suarez, Ziga Rotar, Bjorn Gudbjornsson, Tamara Rusman, Mikkel Østergaard and Merete Lund Hetland
The Journal of Rheumatology December 2022, jrheum.220459; DOI: https://doi.org/10.3899/jrheum.220459
Lykke Midtbøll Ørnbjerg
FUNDING: The EuroSpA Research Collaboration Network was financially supported by Novartis Pharma AG. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit the manuscript. COMPETING INTERESTS: KR: research grant paid to employer from Novartis; LMØ: research grant paid to employer from Novartis; SG: research grant paid to employer from Novartis; SHR: research grant paid to employer from Novartis; UL: none; KP: Roche, BMS, AbbVie, Celgene, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Egis, Medac, Biogen; NY: Consultation fees from Abbvie, Novartis, Pfizer, Johnson&Johnson; EGF: Speaker and consultation fees from Eli Lilly, MSD, Novartis and Janssen; MJN: Speaker fees: AbbVie, Eli Lilly, MSD, Novartis; BM: Novartis; EVS: Research grants: MSD, Pfizer, UCB and speaker fees: Novartis, Abbvie, MSD, Celgene, UCB; GTJ: Abbvie, Pfizer, UCB, Amgen (Celgene), GSK; RI: Speaker fees: Abbvie, Boehringer- Ingelheim, BMS, Novartis, Sandoz, Pfizer, Eli Lilly, Zentiva; HR: Congress fees, speaker fees from Abbvie, Celgene, Pfizer; CSP: none; MT: AbbVie, Amgen, Biogen, Eli Lilly, Janssen, Medias, Medis, MSD, Novartis, OPH Oktal Pharma, Sandoz and Pfizer; AJG: none; IH: AbbVie, Lilly, Novartis , UCB, BMS, MSD, UCB, Pfizer; JA: PI for agreements between Abbvie, Astra-Zeneca, BMS, Eli Lilly, MSD, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB, for ARTIS safety monitoring; AGL: AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB; LN: none; HD: Research Grants, Educational travel support, Speaker and Consulting Fees from Abbvie, Pfizer, Roche, MSD, UCB, Amgen, Novartis, BMS, Celgene and Abdi-ıbrahim; FI: Speaker/consultation fees from AbbVie, Roche, MSD, UCB, Lilly, Janssen, Sanofi, Pfizer, Novartis; AC: Consulting and/or speaking fees from Abbvie, Eli-Lilly, MSD, Novartis, Pfizer; KMF: none; MJS: Speaker fees from Abbvie, Pfizer and Novartis; GJM: Research grant from GSK; CC: Speaker and consulting fees from AbbVie, Amgen, Egis, Ewopharma, Lilly, Novartis, Pfizer, Roche, Sandoz, UCB; KE: Consulting fees: Amgen, Celgene, Gilag, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sobi, UCB; MP: Consulting fees from Abbvie, MSD, Roche; ZR: Speaker and consultation fees from Abbvie, Amgen, Boehringer-Ingelheim, Celgene, Eli Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB; BG: Speaker fees from Novartis and Amgen; TR: none; MØ: research grants from Abbvie, BMS, Merck, Celgene and Novartis, and speaker and/or consultancy fees from Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB; MLH: Research grants from Abbvie, Biogen, BMS, Celltrion, Eli Lilly, Janssen Biologics B.V, Lundbeck Foundation, MSD, Pfizer, Roche, Samsung Biopies, Sandoz, Novartis. STATEMENT OF ETICS AND CONSENT: All participating registries obtained the necessary approvals in accordance with legal, compliance and regulatory requirements from national Data Protection Agencies and/or Research Ethics Boards prior to the data transfer to the EuroSpA coordinating center. CORRESPONDING AUTHOR: Lykke Midtbøll Ørnbjerg, COPECARE, Rigshospitalet, Valdemar Hansens Vej 17, 2600 Glostrup, Denmark. Email: lykke.midtboell.oernbjerg@regionh.dk
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Kathrine Rugbjerg
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Stylianos Georgiadis
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Simon Horskjær
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Lykke Midtbøll Ørnbjerg
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Kathrine Rugbjerg
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Stylianos Georgiadis
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Simon Horskjær Rasmussen
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Ulf Lindström
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Karel Pavelka
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Neslihan Yilmaz
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Ennio Giulio Favalli
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Michael J. Nissen
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Brigitte Michelsen
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Elsa Vieira-Sousa
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Gareth T. Jones
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Ruxandra Ionescu
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Heikki Relas
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Carlos Sanchez-Piedra
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Matija Tomšič
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Arni Jon Geirsson
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Irene van der Horst-Bruinsma
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Johan Askling
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Anne Gitte Loft
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Lucie Nekvindova
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Haner Direskeneli
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Florenzo Iannone
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Karen Minde Fagerli
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Maria José Santos
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Gary J. Macfarlane
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Catalin Codreanu
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Kari Eklund
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Manuel Pombo-Suarez
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Ziga Rotar
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Bjorn Gudbjornsson
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Tamara Rusman
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Mikkel Østergaard
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Merete Lund Hetland
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Abstract

Objective To investigate the distribution of patient-reported outcomes (PROs) in axial spondyloarthritis (axSpA) patients initiating a tumor necrosis factor inhibitor (TNFi), to assess the proportion reaching PRO "remission" across registries and treatment series, and to compare patients registered to fulfill the New York criteria for ankylosing spondylitis (AS) versus non-radiographic axSpA (nr-axSpA) patients.

Methods Fifteen European registries contributed PRO scores for pain, fatigue, patient global, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI) and Health Assessment Questionnaire (HAQ) from 19,498 axSpA patients. Changes in PROs and PRO "remission" rates (definitions: ≤20 mm for pain, fatigue, patient global, BASDAI and BASFI; ≤0.5 for HAQ) were calculated at 6, 12 and 24 months of treatment.

Results Heterogeneity in baseline characteristics and outcomes between registries were observed. In pooled data, six months after start of a 1st TNFi, pain score was reduced by approximately 60% (median at baseline/6/12/24 months: 65/25/20/20 mm) in patients on treatment. Similar patterns were observed for fatigue (68/32/30/25), patient global (66/29/21/20), BASDAI (58/26/21/19), BASFI (46/20/16/16) and HAQ (0.8/0.4/0.2/0.2). Patients with AS, n=3281 had a slightly better response than nr-axSpA patients, n=993. LUNDEX-adjusted "remission" rates at 6 months for pain/fatigue/patient global/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the non-radiographic axSpA cohort. Better PRO responses were seen with a 1st TNFi compared to 2nd and 3rd TNFi.

Conclusion AxSpA patients starting a TNFi achieved high PRO "remission" rates, most pronounced in those fulfilling the modified New York criteria and for the first TNFi.

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Accepted manuscript
One-third of European axial spondyloarthritis patients reach pain"remission" with routine care TNF-inhibitor treatment
Lykke Midtbøll Ørnbjerg, Kathrine Rugbjerg, Stylianos Georgiadis, Simon Horskjær, Lykke Midtbøll Ørnbjerg, Kathrine Rugbjerg, Stylianos Georgiadis, Simon Horskjær Rasmussen, Ulf Lindström, Karel Pavelka, Neslihan Yilmaz, Ennio Giulio Favalli, Michael J. Nissen, Brigitte Michelsen, Elsa Vieira-Sousa, Gareth T. Jones, Ruxandra Ionescu, Heikki Relas, Carlos Sanchez-Piedra, Matija Tomšič, Arni Jon Geirsson, Irene van der Horst-Bruinsma, Johan Askling, Anne Gitte Loft, Lucie Nekvindova, Haner Direskeneli, Florenzo Iannone, Karen Minde Fagerli, Maria José Santos, Gary J. Macfarlane, Catalin Codreanu, Kari Eklund, Manuel Pombo-Suarez, Ziga Rotar, Bjorn Gudbjornsson, Tamara Rusman, Mikkel Østergaard, Merete Lund Hetland
The Journal of Rheumatology Dec 2022, jrheum.220459; DOI: 10.3899/jrheum.220459

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Accepted manuscript
One-third of European axial spondyloarthritis patients reach pain"remission" with routine care TNF-inhibitor treatment
Lykke Midtbøll Ørnbjerg, Kathrine Rugbjerg, Stylianos Georgiadis, Simon Horskjær, Lykke Midtbøll Ørnbjerg, Kathrine Rugbjerg, Stylianos Georgiadis, Simon Horskjær Rasmussen, Ulf Lindström, Karel Pavelka, Neslihan Yilmaz, Ennio Giulio Favalli, Michael J. Nissen, Brigitte Michelsen, Elsa Vieira-Sousa, Gareth T. Jones, Ruxandra Ionescu, Heikki Relas, Carlos Sanchez-Piedra, Matija Tomšič, Arni Jon Geirsson, Irene van der Horst-Bruinsma, Johan Askling, Anne Gitte Loft, Lucie Nekvindova, Haner Direskeneli, Florenzo Iannone, Karen Minde Fagerli, Maria José Santos, Gary J. Macfarlane, Catalin Codreanu, Kari Eklund, Manuel Pombo-Suarez, Ziga Rotar, Bjorn Gudbjornsson, Tamara Rusman, Mikkel Østergaard, Merete Lund Hetland
The Journal of Rheumatology Dec 2022, jrheum.220459; DOI: 10.3899/jrheum.220459
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