One-Third of European Patients with Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment

Lykke Midtbøll Ørnbjerg; Kathrine Rugbjerg; Stylianos Georgiadis; Simon Horskjær; 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

doi:10.3899/jrheum.220459

One-Third of European Patients with Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment

Lykke Midtbøll Ørnbjerg^*, Kathrine Rugbjerg, Stylianos Georgiadis, Simon Horskjær, 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 GeirssonIrene 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

^*Corresponding author for this work

Department for Rheumatology and Spine Diseases

Abstract

OBJECTIVE: To investigate the distribution of patient-reported outcomes (PROs) in patients with axial spondyloarthritis (axSpA) 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 modified New York (mNY) criteria for ankylosing spondylitis (AS) vs patients with nonradiographic axSpA (nr-axSpA).

METHODS: Fifteen European registries contributed PRO scores for pain, fatigue, patient global assessment (PtGA), Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and Health Assessment Questionnaire (HAQ) from 19,498 patients with axSpA. Changes in PROs and PRO remission rates (definitions: ≤ 20 mm for pain, fatigue, PtGA, 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, 6 months after the start of a first 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 mm), PtGA (66/29/21/20 mm), BASDAI (58/26/21/19 mm), BASFI (46/20/16/16 mm), and HAQ (0.8/0.4/0.2/0.2). Patients with AS (n = 3281) had a slightly better response than patients with nr-axSpA (n = 993). The Lund Efficacy Index (LUNDEX)-adjusted remission rates at 6 months for pain/fatigue/PtGA/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the nr-axSpA cohort. Better PRO responses were seen with a first TNFi compared to a second and third TNFi.

CONCLUSION: Patients with axSpA starting a TNFi achieved high PRO remission rates, most pronounced in those fulfilling the mNY criteria and for the first TNFi.

Original language	English
Journal	Journal of Rheumatology
Volume	50
Issue number	8
Pages (from-to)	1009-1019
Number of pages	11
ISSN	0315-162X
DOIs	https://doi.org/10.3899/jrheum.220459
Publication status	Published - Aug 2023

Keywords

Fatigue/drug therapy
Humans
Non-Radiographic Axial Spondyloarthritis
Pain
Spondylarthritis/drug therapy
Spondylitis, Ankylosing/drug therapy
Treatment Outcome
Tumor Necrosis Factor Inhibitors/therapeutic use
Tumor Necrosis Factor-alpha

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Ørnbjerg, L. M., Rugbjerg, K., Georgiadis, S., Horskjær, S., Rugbjerg, K., Georgiadis, S., Rasmussen, S. H., Lindström, U., Pavelka, K., Yilmaz, N., Favalli, E. G., Nissen, M. J., Michelsen, B., Vieira-Sousa, E., Jones, G. T., Ionescu, R., Relas, H., Sanchez-Piedra, C., Tomšič, M., ... Hetland, M. L. (2023). One-Third of European Patients with Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment. Journal of Rheumatology, 50(8), 1009-1019. https://doi.org/10.3899/jrheum.220459

One-Third of European Patients with Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment. / Ørnbjerg, Lykke Midtbøll; Rugbjerg, Kathrine; Georgiadis, Stylianos et al.
In: Journal of Rheumatology, Vol. 50, No. 8, 08.2023, p. 1009-1019.

Research output: Contribution to journal › Journal article › Research › peer-review

Ørnbjerg, LM, Rugbjerg, K, Georgiadis, S, Horskjær, S, Rugbjerg, K, Georgiadis, S, Rasmussen, SH, Lindström, U, Pavelka, K, Yilmaz, N, Favalli, EG, Nissen, MJ, Michelsen, B, Vieira-Sousa, E, Jones, GT, Ionescu, R, Relas, H, Sanchez-Piedra, C, Tomšič, M, Geirsson, AJ, van der Horst-Bruinsma, I, Askling, J, Loft, AG, Nekvindova, L, Direskeneli, H, Iannone, F, Fagerli, KM, Santos, MJ, Macfarlane, GJ, Codreanu, C, Eklund, K, Pombo-Suarez, M, Rotar, Z, Gudbjornsson, B, Rusman, T, Østergaard, M & Hetland, ML 2023, 'One-Third of European Patients with Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment', Journal of Rheumatology, vol. 50, no. 8, pp. 1009-1019. https://doi.org/10.3899/jrheum.220459

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title = "One-Third of European Patients with Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment",

abstract = "OBJECTIVE: To investigate the distribution of patient-reported outcomes (PROs) in patients with axial spondyloarthritis (axSpA) 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 modified New York (mNY) criteria for ankylosing spondylitis (AS) vs patients with nonradiographic axSpA (nr-axSpA).METHODS: Fifteen European registries contributed PRO scores for pain, fatigue, patient global assessment (PtGA), Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and Health Assessment Questionnaire (HAQ) from 19,498 patients with axSpA. Changes in PROs and PRO remission rates (definitions: ≤ 20 mm for pain, fatigue, PtGA, 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, 6 months after the start of a first 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 mm), PtGA (66/29/21/20 mm), BASDAI (58/26/21/19 mm), BASFI (46/20/16/16 mm), and HAQ (0.8/0.4/0.2/0.2). Patients with AS (n = 3281) had a slightly better response than patients with nr-axSpA (n = 993). The Lund Efficacy Index (LUNDEX)-adjusted remission rates at 6 months for pain/fatigue/PtGA/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the nr-axSpA cohort. Better PRO responses were seen with a first TNFi compared to a second and third TNFi.CONCLUSION: Patients with axSpA starting a TNFi achieved high PRO remission rates, most pronounced in those fulfilling the mNY criteria and for the first TNFi.",

keywords = "Fatigue/drug therapy, Humans, Non-Radiographic Axial Spondyloarthritis, Pain, Spondylarthritis/drug therapy, Spondylitis, Ankylosing/drug therapy, Treatment Outcome, Tumor Necrosis Factor Inhibitors/therapeutic use, Tumor Necrosis Factor-alpha",

author = "{\O}rnbjerg, {Lykke Midtb{\o}ll} and Kathrine Rugbjerg and Stylianos Georgiadis and Simon Horskj{\ae}r and Kathrine Rugbjerg and Stylianos Georgiadis and Rasmussen, {Simon Horskj{\ae}r} and Ulf Lindstr{\"o}m and Karel Pavelka and Neslihan Yilmaz and Favalli, {Ennio Giulio} and Nissen, {Michael J} and Brigitte Michelsen and Elsa Vieira-Sousa and Jones, {Gareth T} and Ruxandra Ionescu and Heikki Relas and Carlos Sanchez-Piedra and Matija Tom{\v s}i{\v c} and Geirsson, {Arni Jon} and {van der Horst-Bruinsma}, Irene and Johan Askling and Loft, {Anne Gitte} and Lucie Nekvindova and Haner Direskeneli and Florenzo Iannone and Fagerli, {Karen Minde} and Santos, {Maria Jos{\'e}} and Macfarlane, {Gary J} and Catalin Codreanu and Kari Eklund and Manuel Pombo-Suarez and Ziga Rotar and Bjorn Gudbjornsson and Tamara Rusman and Mikkel {\O}stergaard and Hetland, {Merete Lund}",

note = "COPECARE",

year = "2023",

month = aug,

doi = "10.3899/jrheum.220459",

language = "English",

volume = "50",

pages = "1009--1019",

journal = "Journal of Rheumatology",

issn = "0315-162X",

publisher = "Journal of Rheumatology Publishing Co. Ltd",

number = "8",

}

TY - JOUR

T1 - One-Third of European Patients with Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment

AU - Ørnbjerg, Lykke Midtbøll

AU - Rugbjerg, Kathrine

AU - Georgiadis, Stylianos

AU - Horskjær, Simon

AU - Rugbjerg, Kathrine

AU - Georgiadis, Stylianos

AU - Rasmussen, Simon Horskjær

AU - Lindström, Ulf

AU - Pavelka, Karel

AU - Yilmaz, Neslihan

AU - Favalli, Ennio Giulio

AU - Nissen, Michael J

AU - Michelsen, Brigitte

AU - Vieira-Sousa, Elsa

AU - Jones, Gareth T

AU - Ionescu, Ruxandra

AU - Relas, Heikki

AU - Sanchez-Piedra, Carlos

AU - Tomšič, Matija

AU - Geirsson, Arni Jon

AU - van der Horst-Bruinsma, Irene

AU - Askling, Johan

AU - Loft, Anne Gitte

AU - Nekvindova, Lucie

AU - Direskeneli, Haner

AU - Iannone, Florenzo

AU - Fagerli, Karen Minde

AU - Santos, Maria José

AU - Macfarlane, Gary J

AU - Codreanu, Catalin

AU - Eklund, Kari

AU - Pombo-Suarez, Manuel

AU - Rotar, Ziga

AU - Gudbjornsson, Bjorn

AU - Rusman, Tamara

AU - Østergaard, Mikkel

AU - Hetland, Merete Lund

N1 - COPECARE

PY - 2023/8

Y1 - 2023/8

N2 - OBJECTIVE: To investigate the distribution of patient-reported outcomes (PROs) in patients with axial spondyloarthritis (axSpA) 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 modified New York (mNY) criteria for ankylosing spondylitis (AS) vs patients with nonradiographic axSpA (nr-axSpA).METHODS: Fifteen European registries contributed PRO scores for pain, fatigue, patient global assessment (PtGA), Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and Health Assessment Questionnaire (HAQ) from 19,498 patients with axSpA. Changes in PROs and PRO remission rates (definitions: ≤ 20 mm for pain, fatigue, PtGA, 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, 6 months after the start of a first 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 mm), PtGA (66/29/21/20 mm), BASDAI (58/26/21/19 mm), BASFI (46/20/16/16 mm), and HAQ (0.8/0.4/0.2/0.2). Patients with AS (n = 3281) had a slightly better response than patients with nr-axSpA (n = 993). The Lund Efficacy Index (LUNDEX)-adjusted remission rates at 6 months for pain/fatigue/PtGA/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the nr-axSpA cohort. Better PRO responses were seen with a first TNFi compared to a second and third TNFi.CONCLUSION: Patients with axSpA starting a TNFi achieved high PRO remission rates, most pronounced in those fulfilling the mNY criteria and for the first TNFi.

AB - OBJECTIVE: To investigate the distribution of patient-reported outcomes (PROs) in patients with axial spondyloarthritis (axSpA) 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 modified New York (mNY) criteria for ankylosing spondylitis (AS) vs patients with nonradiographic axSpA (nr-axSpA).METHODS: Fifteen European registries contributed PRO scores for pain, fatigue, patient global assessment (PtGA), Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and Health Assessment Questionnaire (HAQ) from 19,498 patients with axSpA. Changes in PROs and PRO remission rates (definitions: ≤ 20 mm for pain, fatigue, PtGA, 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, 6 months after the start of a first 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 mm), PtGA (66/29/21/20 mm), BASDAI (58/26/21/19 mm), BASFI (46/20/16/16 mm), and HAQ (0.8/0.4/0.2/0.2). Patients with AS (n = 3281) had a slightly better response than patients with nr-axSpA (n = 993). The Lund Efficacy Index (LUNDEX)-adjusted remission rates at 6 months for pain/fatigue/PtGA/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the nr-axSpA cohort. Better PRO responses were seen with a first TNFi compared to a second and third TNFi.CONCLUSION: Patients with axSpA starting a TNFi achieved high PRO remission rates, most pronounced in those fulfilling the mNY criteria and for the first TNFi.

KW - Fatigue/drug therapy

KW - Humans

KW - Non-Radiographic Axial Spondyloarthritis

KW - Pain

KW - Spondylarthritis/drug therapy

KW - Spondylitis, Ankylosing/drug therapy

KW - Treatment Outcome

KW - Tumor Necrosis Factor Inhibitors/therapeutic use

KW - Tumor Necrosis Factor-alpha

UR - http://www.scopus.com/inward/record.url?scp=85166052278&partnerID=8YFLogxK

U2 - 10.3899/jrheum.220459

DO - 10.3899/jrheum.220459

M3 - Journal article

C2 - 36455943

SN - 0315-162X

VL - 50

SP - 1009

EP - 1019

JO - Journal of Rheumatology

JF - Journal of Rheumatology

IS - 8

ER -

One-Third of European Patients with Axial Spondyloarthritis Reach Pain Remission With Routine Care Tumor Necrosis Factor Inhibitor Treatment

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