Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies

Ana-Maria Orbai; M Elaine Husni; Dafna D Gladman; Ying Ying Leung; Stefan Siebert; William Tillett; Marijn Vis; Olivier Chambenoit; Xiangyi Meng; Philip J Mease

doi:10.1007/s40744-021-00337-5

Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies

Ana-Maria Orbai, M Elaine Husni, Dafna D Gladman, Ying Ying Leung, Stefan Siebert, William Tillett, Marijn Vis, Olivier Chambenoit, Xiangyi Meng, Philip J Mease

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

8 Citations (SciVal)

Abstract

BACKGROUND: Psoriatic arthritis (PsA) is a chronic, heterogeneous, immune-mediated disease manifesting as a spectrum of possible inflammatory signs and symptoms. Clinicians need therapeutic choices that work across all active PsA disease domains, as well as practical information about efficacy of available treatments for individual domains in specific groups of patients. The objective of this study was to evaluate the effect of prior tumor necrosis factor inhibitor (TNFi) exposure on the efficacy of secukinumab across PsA core domains.

METHODS: Data were pooled from 2049 participants with PsA in four phase 3 studies (FUTURE 2-5). Efficacy at week 16 was evaluated for each GRAPPA-OMERACT PsA core domain using nonresponder imputation for musculoskeletal disease activity and Psoriasis Area and Severity Index scores or as-observed data for other outcomes. For each measure, comparisons with placebo were made separately in the TNFi-naive and TNFi-inadequate responder/intolerant (TNF-IR) cohorts.

RESULTS: Treatment with secukinumab improved PsA disease activity across all disease domains regardless of previous TNFi use, although TNFi-naive patients experienced numerically greater benefits in most outcomes. Among patients treated with secukinumab 300 mg, 41.5% and 24.4% of TNFi-naive patients (P < 0.05 vs placebo) and 18.6% and 9.0% of TNF-IR patients (nonsignificant vs placebo) experienced resolution in 66 swollen and 68 tender joint counts, respectively; additionally, 37.2% of TNFi-naive patients and 24.2% of TNF-IR patients achieved complete resolution of psoriasis at week 16 (all P < 0.05 vs placebo). Secukinumab effect sizes were generally larger in TNFi-naive vs TNF-IR patients for musculoskeletal and patient-reported domains.

CONCLUSIONS: Secukinumab demonstrated efficacy vs placebo across GRAPPA-OMERACT PsA core domains. Higher responses among TNFi-naive vs TNF-IR patients suggest that secukinumab should be considered for first-line use in PsA.

Original language	English
Pages (from-to)	1223-1240
Number of pages	18
Journal	Rheumatology and therapy
Volume	8
Issue number	3
Early online date	3 Jul 2021
DOIs	https://doi.org/10.1007/s40744-021-00337-5
Publication status	Published - 30 Sept 2021

Bibliographical note

Funding

A.-M. Orbai: received research grant support from AbbVie, Celgene, Horizon, Janssen, Lilly, and Novartis; received consulting fees from Janssen, Lilly, Novartis, Pfizer, and UCB; is a Jerome L. Greene Foundation Scholar; is supported in part by a research grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under award number P30- AR070254 (Core B), a Rheumatology Research Foundation Scientist Development Award, and a Staurulakis Family Discovery Award; is an Assistant Professor in the Department of Medicine, Division of Rheumatology, at the Johns Hopkins University School of Medicine; engaged in this research as an author and not in her capacity as a Johns Hopkins faculty member and was not compensated in income for being an author on this manuscript; and received no compensation from the National Institutes of Health for the development of this manuscript. M.E. Husni: received research grant support from Pfizer and consulting fees from AbbVie, Amgen, Gilead, Janssen, Lilly, Novartis, Pfizer, Regeneron, and UCB. D.D. Gladman: received research grant support from AbbVie, Amgen, Celgene, Lilly, Novartis, Pfizer, and UCB and consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB. Y.Y. Leung: received speakers bureau fees from Janssen, AbbVie, Lilly, and Novartis and is a member of the editorial board of BMC Rheumatology. S. Siebert: received research grant support from Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Janssen, Novartis, Pfizer, GSK, and UCB; received consulting fees from AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, and UCB; and received speakers bureau fees from AbbVie, Janssen, MSD, Novartis, Pfizer, and UCB. W. Tillett: received research grant support from AbbVie, Celgene, and Lilly; received consulting fees from AbbVie, Celgene, Lilly, Novartis, UCB, and Pfizer; and received speakers bureau fees from AbbVie, Celgene, Lilly, Janssen, Novartis, Pfizer, and UCB. M. Vis: received research grant support from Novartis. O. Chambenoit and X. Meng: employees and stockholders of Novartis. P.J. Mease: received research grants from AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, Sun Pharma, and UCB; received consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sun Pharma, and UCB; and received speakers bureau fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. This study and the Rapid Service Fee was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Support for third-party writing assistance for this manuscript was provided by Novartis.

Access to Document

10.1007/s40744-021-00337-5Licence: CC BY

1 Finished
1 Not started

The Impact of Biologic and Targeted Synthetic Disease Modifying Drugs in Psoriatic Arthritis
Tillett, W. (PI)
Project: UK industry
Outcome Measures for Randomised Controlled Trials in Psoriatic Arthritis
Tillett, W. (PI)
1/09/16 → 3/07/20
Project: Central government, health and local authorities

Cite this

Orbai, A.-M., Husni, M. E., Gladman, D. D., Leung, Y. Y., Siebert, S., Tillett, W., Vis, M., Chambenoit, O., Meng, X., & Mease, P. J. (2021). Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies. Rheumatology and therapy, 8(3), 1223-1240. https://doi.org/10.1007/s40744-021-00337-5

Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies. / Orbai, Ana-Maria; Husni, M Elaine; Gladman, Dafna D et al.
In: Rheumatology and therapy, Vol. 8, No. 3, 30.09.2021, p. 1223-1240.

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

Orbai, A-M, Husni, ME, Gladman, DD, Leung, YY, Siebert, S, Tillett, W, Vis, M, Chambenoit, O, Meng, X & Mease, PJ 2021, 'Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies', Rheumatology and therapy, vol. 8, no. 3, pp. 1223-1240. https://doi.org/10.1007/s40744-021-00337-5

@article{39176cf5cd3f4fa58a80ebb58a3593b9,

title = "Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies",

abstract = "BACKGROUND: Psoriatic arthritis (PsA) is a chronic, heterogeneous, immune-mediated disease manifesting as a spectrum of possible inflammatory signs and symptoms. Clinicians need therapeutic choices that work across all active PsA disease domains, as well as practical information about efficacy of available treatments for individual domains in specific groups of patients. The objective of this study was to evaluate the effect of prior tumor necrosis factor inhibitor (TNFi) exposure on the efficacy of secukinumab across PsA core domains.METHODS: Data were pooled from 2049 participants with PsA in four phase 3 studies (FUTURE 2-5). Efficacy at week 16 was evaluated for each GRAPPA-OMERACT PsA core domain using nonresponder imputation for musculoskeletal disease activity and Psoriasis Area and Severity Index scores or as-observed data for other outcomes. For each measure, comparisons with placebo were made separately in the TNFi-naive and TNFi-inadequate responder/intolerant (TNF-IR) cohorts.RESULTS: Treatment with secukinumab improved PsA disease activity across all disease domains regardless of previous TNFi use, although TNFi-naive patients experienced numerically greater benefits in most outcomes. Among patients treated with secukinumab 300 mg, 41.5% and 24.4% of TNFi-naive patients (P < 0.05 vs placebo) and 18.6% and 9.0% of TNF-IR patients (nonsignificant vs placebo) experienced resolution in 66 swollen and 68 tender joint counts, respectively; additionally, 37.2% of TNFi-naive patients and 24.2% of TNF-IR patients achieved complete resolution of psoriasis at week 16 (all P < 0.05 vs placebo). Secukinumab effect sizes were generally larger in TNFi-naive vs TNF-IR patients for musculoskeletal and patient-reported domains.CONCLUSIONS: Secukinumab demonstrated efficacy vs placebo across GRAPPA-OMERACT PsA core domains. Higher responses among TNFi-naive vs TNF-IR patients suggest that secukinumab should be considered for first-line use in PsA.",

author = "Ana-Maria Orbai and Husni, {M Elaine} and Gladman, {Dafna D} and Leung, {Ying Ying} and Stefan Siebert and William Tillett and Marijn Vis and Olivier Chambenoit and Xiangyi Meng and Mease, {Philip J}",

note = "{\textcopyright} 2021. The Author(s).",

year = "2021",

month = sep,

day = "30",

doi = "10.1007/s40744-021-00337-5",

language = "English",

volume = "8",

pages = "1223--1240",

journal = "Rheumatology and therapy",

issn = "2198-6576",

publisher = "Adis International Ltd",

number = "3",

}

TY - JOUR

T1 - Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use

T2 - Pooled Analysis of Four Phase 3 Studies

AU - Orbai, Ana-Maria

AU - Husni, M Elaine

AU - Gladman, Dafna D

AU - Leung, Ying Ying

AU - Siebert, Stefan

AU - Tillett, William

AU - Vis, Marijn

AU - Chambenoit, Olivier

AU - Meng, Xiangyi

AU - Mease, Philip J

PY - 2021/9/30

Y1 - 2021/9/30

N2 - BACKGROUND: Psoriatic arthritis (PsA) is a chronic, heterogeneous, immune-mediated disease manifesting as a spectrum of possible inflammatory signs and symptoms. Clinicians need therapeutic choices that work across all active PsA disease domains, as well as practical information about efficacy of available treatments for individual domains in specific groups of patients. The objective of this study was to evaluate the effect of prior tumor necrosis factor inhibitor (TNFi) exposure on the efficacy of secukinumab across PsA core domains.METHODS: Data were pooled from 2049 participants with PsA in four phase 3 studies (FUTURE 2-5). Efficacy at week 16 was evaluated for each GRAPPA-OMERACT PsA core domain using nonresponder imputation for musculoskeletal disease activity and Psoriasis Area and Severity Index scores or as-observed data for other outcomes. For each measure, comparisons with placebo were made separately in the TNFi-naive and TNFi-inadequate responder/intolerant (TNF-IR) cohorts.RESULTS: Treatment with secukinumab improved PsA disease activity across all disease domains regardless of previous TNFi use, although TNFi-naive patients experienced numerically greater benefits in most outcomes. Among patients treated with secukinumab 300 mg, 41.5% and 24.4% of TNFi-naive patients (P < 0.05 vs placebo) and 18.6% and 9.0% of TNF-IR patients (nonsignificant vs placebo) experienced resolution in 66 swollen and 68 tender joint counts, respectively; additionally, 37.2% of TNFi-naive patients and 24.2% of TNF-IR patients achieved complete resolution of psoriasis at week 16 (all P < 0.05 vs placebo). Secukinumab effect sizes were generally larger in TNFi-naive vs TNF-IR patients for musculoskeletal and patient-reported domains.CONCLUSIONS: Secukinumab demonstrated efficacy vs placebo across GRAPPA-OMERACT PsA core domains. Higher responses among TNFi-naive vs TNF-IR patients suggest that secukinumab should be considered for first-line use in PsA.

AB - BACKGROUND: Psoriatic arthritis (PsA) is a chronic, heterogeneous, immune-mediated disease manifesting as a spectrum of possible inflammatory signs and symptoms. Clinicians need therapeutic choices that work across all active PsA disease domains, as well as practical information about efficacy of available treatments for individual domains in specific groups of patients. The objective of this study was to evaluate the effect of prior tumor necrosis factor inhibitor (TNFi) exposure on the efficacy of secukinumab across PsA core domains.METHODS: Data were pooled from 2049 participants with PsA in four phase 3 studies (FUTURE 2-5). Efficacy at week 16 was evaluated for each GRAPPA-OMERACT PsA core domain using nonresponder imputation for musculoskeletal disease activity and Psoriasis Area and Severity Index scores or as-observed data for other outcomes. For each measure, comparisons with placebo were made separately in the TNFi-naive and TNFi-inadequate responder/intolerant (TNF-IR) cohorts.RESULTS: Treatment with secukinumab improved PsA disease activity across all disease domains regardless of previous TNFi use, although TNFi-naive patients experienced numerically greater benefits in most outcomes. Among patients treated with secukinumab 300 mg, 41.5% and 24.4% of TNFi-naive patients (P < 0.05 vs placebo) and 18.6% and 9.0% of TNF-IR patients (nonsignificant vs placebo) experienced resolution in 66 swollen and 68 tender joint counts, respectively; additionally, 37.2% of TNFi-naive patients and 24.2% of TNF-IR patients achieved complete resolution of psoriasis at week 16 (all P < 0.05 vs placebo). Secukinumab effect sizes were generally larger in TNFi-naive vs TNF-IR patients for musculoskeletal and patient-reported domains.CONCLUSIONS: Secukinumab demonstrated efficacy vs placebo across GRAPPA-OMERACT PsA core domains. Higher responses among TNFi-naive vs TNF-IR patients suggest that secukinumab should be considered for first-line use in PsA.

U2 - 10.1007/s40744-021-00337-5

DO - 10.1007/s40744-021-00337-5

M3 - Article

C2 - 34218429

SN - 2198-6576

VL - 8

SP - 1223

EP - 1240

JO - Rheumatology and therapy

JF - Rheumatology and therapy

IS - 3

ER -

Secukinumab Efficacy on Psoriatic Arthritis GRAPPA-OMERACT Core Domains in Patients with or Without Prior Tumor Necrosis Factor Inhibitor Use: Pooled Analysis of Four Phase 3 Studies

Abstract

Bibliographical note

Funding

Access to Document

Fingerprint

Projects

The Impact of Biologic and Targeted Synthetic Disease Modifying Drugs in Psoriatic Arthritis

Outcome Measures for Randomised Controlled Trials in Psoriatic Arthritis

Cite this