Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies

Dafna Gladman; William Tillett; David Gruben; Laura C Coates; Stefanie Hahne; Mikhail Volkov

doi:10.1136/rmdopen-2024-005250

Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies

Dafna Gladman, William Tillett, David Gruben, Laura C Coates, Stefanie Hahne, Mikhail Volkov

Research output: Contribution to journal › Article › peer-review

Abstract

OBJECTIVE: To capture variations in tofacitinib treatment response in psoriatic arthritis (PsA) by identifying patient groups with distinct disease activity trajectories.

METHODS: Data were pooled post hoc from two phase 3 studies (OPAL Broaden, OPAL Beyond) in patients with PsA receiving tofacitinib 5 or 10 mg twice daily (n=225, n=226, respectively). Psoriatic Arthritis Disease Activity Score (PASDAS) to month 6 was used in group-based trajectory modelling to identify distinct treatment response groups based on disease state (very low/low/moderate/high disease activity (VLDA/LDA/MoDA/HDA, respectively)). Baseline characteristics, PASDAS components to month 6 and adverse events (AEs) were assessed.

RESULTS: Five trajectory groups were identified for both tofacitinib doses: groups improved from MoDA→VLDA/LDA (group 1); HDA→VLDA (group 2); HDA→MoDA rapidly (group 3) or gradually (group 4) or remained in HDA (group 5). Groups 4/5 generally had significantly higher baseline PsA clinical domain scores than groups 1‒3, except for Psoriasis Area and Severity Index/Nail Psoriasis Severity Index. Baseline Leeds Enthesitis Index/Spondyloarthritis Research Consortium of Canada enthesitis scores and tender joint counts were significantly higher in group 4 vs group 2. PASDAS components generally improved to month 6 in all groups, consistent with modelled trajectories. There were no clear trends in AEs across groups.

CONCLUSIONS: In patients with PsA receiving tofacitinib, five distinct trajectory groups were identified with different baseline characteristics and treatment outcomes, but no clear trends in AEs. The tofacitinib 5 and 10 mg twice daily models showed comparable trajectories and baseline characteristics. In patients with HDA, enthesitis and tender joint count may impact timing and/or magnitude of response to tofacitinib. Identifying characteristics that impact treatment response may aid personalised treatment algorithm development.

TRIAL REGISTRATION NUMBERS: NCT01877668/NCT01882439.

Original language	English
Article number	e005250
Journal	RMD Open
Volume	11
Issue number	2
Early online date	3 Jun 2025
DOIs	https://doi.org/10.1136/rmdopen-2024-005250
Publication status	Published - 3 Jun 2025

Bibliographical note

Publisher Copyright:
© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.

Funding

DGl has acted as a consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead Sciences, Janssen, Novartis, Pfizer Inc and UCB and has received grants and/or research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc and UCB. WT has acted as a consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ono-Pharma, Pfizer Inc and UCB, has received grants and/or research support from AbbVie, Eli Lilly, Janssen, Pfizer Inc and UCB and has been a member of the speaker bureau for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ono-Pharma, Pfizer Inc and UCB. DGr is an employee and a stockholder of Pfizer Inc. LCC has acted as a consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead Sciences, Janssen, MoonLake, Novartis, Pfizer Inc and UCB, has received grants and/or research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc and UCB and has been a member of the speaker bureau for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead Sciences, GSK, Janssen, Medac, Novartis, Pfizer Inc and UCB. SH is an employee of Pfizer Pharma and a stockholder of Pfizer Inc. MV was an employee of Pfizer BV at the time of this analysis and is a stockholder of Pfizer Inc. Medical writing support, under the direction of the authors, was provided by Justine Juana, BHSc, and Julia King, PhD, of CMC Connect, IPG Health Medical Communications, and was funded by Pfizer, New York, NY, USA, in accordance with Good Publication Practice (GPP 2022) guidelines (Ann Intern Med 2022;175(9):1298\u20131304).

Funders	Funder number
Celgene
IPG Health Medical Communications
Bristol Myers Squibb
UCB
CMC Connect
Eli Lilly and Company Ltd
Amgen
Abbvie, Inc
GlaxoSmithKline
Gilead Sciences
Pfizer	1298–1304

Keywords

Humans
Arthritis, Psoriatic/drug therapy
Pyrimidines/administration & dosage
Male
Piperidines/administration & dosage
Female
Middle Aged
Severity of Illness Index
Treatment Outcome
Adult
Protein Kinase Inhibitors/administration & dosage
Aged
Antirheumatic Agents
Arthritis, Psoriatic
Therapeutics

ASJC Scopus subject areas

Rheumatology
Immunology and Allergy
Immunology

Access to Document

10.1136/rmdopen-2024-005250Licence: CC BY-NC

Cite this

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title = "Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies",

abstract = "OBJECTIVE: To capture variations in tofacitinib treatment response in psoriatic arthritis (PsA) by identifying patient groups with distinct disease activity trajectories.METHODS: Data were pooled post hoc from two phase 3 studies (OPAL Broaden, OPAL Beyond) in patients with PsA receiving tofacitinib 5 or 10 mg twice daily (n=225, n=226, respectively). Psoriatic Arthritis Disease Activity Score (PASDAS) to month 6 was used in group-based trajectory modelling to identify distinct treatment response groups based on disease state (very low/low/moderate/high disease activity (VLDA/LDA/MoDA/HDA, respectively)). Baseline characteristics, PASDAS components to month 6 and adverse events (AEs) were assessed.RESULTS: Five trajectory groups were identified for both tofacitinib doses: groups improved from MoDA→VLDA/LDA (group 1); HDA→VLDA (group 2); HDA→MoDA rapidly (group 3) or gradually (group 4) or remained in HDA (group 5). Groups 4/5 generally had significantly higher baseline PsA clinical domain scores than groups 1‒3, except for Psoriasis Area and Severity Index/Nail Psoriasis Severity Index. Baseline Leeds Enthesitis Index/Spondyloarthritis Research Consortium of Canada enthesitis scores and tender joint counts were significantly higher in group 4 vs group 2. PASDAS components generally improved to month 6 in all groups, consistent with modelled trajectories. There were no clear trends in AEs across groups.CONCLUSIONS: In patients with PsA receiving tofacitinib, five distinct trajectory groups were identified with different baseline characteristics and treatment outcomes, but no clear trends in AEs. The tofacitinib 5 and 10 mg twice daily models showed comparable trajectories and baseline characteristics. In patients with HDA, enthesitis and tender joint count may impact timing and/or magnitude of response to tofacitinib. Identifying characteristics that impact treatment response may aid personalised treatment algorithm development.TRIAL REGISTRATION NUMBERS: NCT01877668/NCT01882439.",

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author = "Dafna Gladman and William Tillett and David Gruben and Coates, \{Laura C\} and Stefanie Hahne and Mikhail Volkov",

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.",

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doi = "10.1136/rmdopen-2024-005250",

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T1 - Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib

T2 - a post hoc analysis of two phase 3 studies

AU - Gladman, Dafna

AU - Tillett, William

AU - Gruben, David

AU - Coates, Laura C

AU - Hahne, Stefanie

AU - Volkov, Mikhail

N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.

PY - 2025/6/3

Y1 - 2025/6/3

N2 - OBJECTIVE: To capture variations in tofacitinib treatment response in psoriatic arthritis (PsA) by identifying patient groups with distinct disease activity trajectories.METHODS: Data were pooled post hoc from two phase 3 studies (OPAL Broaden, OPAL Beyond) in patients with PsA receiving tofacitinib 5 or 10 mg twice daily (n=225, n=226, respectively). Psoriatic Arthritis Disease Activity Score (PASDAS) to month 6 was used in group-based trajectory modelling to identify distinct treatment response groups based on disease state (very low/low/moderate/high disease activity (VLDA/LDA/MoDA/HDA, respectively)). Baseline characteristics, PASDAS components to month 6 and adverse events (AEs) were assessed.RESULTS: Five trajectory groups were identified for both tofacitinib doses: groups improved from MoDA→VLDA/LDA (group 1); HDA→VLDA (group 2); HDA→MoDA rapidly (group 3) or gradually (group 4) or remained in HDA (group 5). Groups 4/5 generally had significantly higher baseline PsA clinical domain scores than groups 1‒3, except for Psoriasis Area and Severity Index/Nail Psoriasis Severity Index. Baseline Leeds Enthesitis Index/Spondyloarthritis Research Consortium of Canada enthesitis scores and tender joint counts were significantly higher in group 4 vs group 2. PASDAS components generally improved to month 6 in all groups, consistent with modelled trajectories. There were no clear trends in AEs across groups.CONCLUSIONS: In patients with PsA receiving tofacitinib, five distinct trajectory groups were identified with different baseline characteristics and treatment outcomes, but no clear trends in AEs. The tofacitinib 5 and 10 mg twice daily models showed comparable trajectories and baseline characteristics. In patients with HDA, enthesitis and tender joint count may impact timing and/or magnitude of response to tofacitinib. Identifying characteristics that impact treatment response may aid personalised treatment algorithm development.TRIAL REGISTRATION NUMBERS: NCT01877668/NCT01882439.

AB - OBJECTIVE: To capture variations in tofacitinib treatment response in psoriatic arthritis (PsA) by identifying patient groups with distinct disease activity trajectories.METHODS: Data were pooled post hoc from two phase 3 studies (OPAL Broaden, OPAL Beyond) in patients with PsA receiving tofacitinib 5 or 10 mg twice daily (n=225, n=226, respectively). Psoriatic Arthritis Disease Activity Score (PASDAS) to month 6 was used in group-based trajectory modelling to identify distinct treatment response groups based on disease state (very low/low/moderate/high disease activity (VLDA/LDA/MoDA/HDA, respectively)). Baseline characteristics, PASDAS components to month 6 and adverse events (AEs) were assessed.RESULTS: Five trajectory groups were identified for both tofacitinib doses: groups improved from MoDA→VLDA/LDA (group 1); HDA→VLDA (group 2); HDA→MoDA rapidly (group 3) or gradually (group 4) or remained in HDA (group 5). Groups 4/5 generally had significantly higher baseline PsA clinical domain scores than groups 1‒3, except for Psoriasis Area and Severity Index/Nail Psoriasis Severity Index. Baseline Leeds Enthesitis Index/Spondyloarthritis Research Consortium of Canada enthesitis scores and tender joint counts were significantly higher in group 4 vs group 2. PASDAS components generally improved to month 6 in all groups, consistent with modelled trajectories. There were no clear trends in AEs across groups.CONCLUSIONS: In patients with PsA receiving tofacitinib, five distinct trajectory groups were identified with different baseline characteristics and treatment outcomes, but no clear trends in AEs. The tofacitinib 5 and 10 mg twice daily models showed comparable trajectories and baseline characteristics. In patients with HDA, enthesitis and tender joint count may impact timing and/or magnitude of response to tofacitinib. Identifying characteristics that impact treatment response may aid personalised treatment algorithm development.TRIAL REGISTRATION NUMBERS: NCT01877668/NCT01882439.

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KW - Treatment Outcome

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Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

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Automated Image Recognition in Psoriatic Arthritis: AI-PsA

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Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

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Automated Image Recognition in Psoriatic Arthritis: AI-PsA

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