Cargando…
Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study
OBJECTIVE: To evaluate long‐term outcomes in psoriatic arthritis (PsA) patients who achieved or did not achieve minimal disease activity (MDA) through 5 years of golimumab treatment in the GO‐REVEAL trial. METHODS: The GO‐REVEAL trial was a phase III, randomized, double‐blind trial with placebo‐cont...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5066795/ https://www.ncbi.nlm.nih.gov/pubmed/25779603 http://dx.doi.org/10.1002/acr.22576 |
_version_ | 1782460543045468160 |
---|---|
author | Kavanaugh, Arthur van der Heijde, Désirée Beutler, Anna Gladman, Dafna Mease, Philip Krueger, Gerald G. McInnes, Iain B. Helliwell, Philip Coates, Laura C. Xu, Stephen |
author_facet | Kavanaugh, Arthur van der Heijde, Désirée Beutler, Anna Gladman, Dafna Mease, Philip Krueger, Gerald G. McInnes, Iain B. Helliwell, Philip Coates, Laura C. Xu, Stephen |
author_sort | Kavanaugh, Arthur |
collection | PubMed |
description | OBJECTIVE: To evaluate long‐term outcomes in psoriatic arthritis (PsA) patients who achieved or did not achieve minimal disease activity (MDA) through 5 years of golimumab treatment in the GO‐REVEAL trial. METHODS: The GO‐REVEAL trial was a phase III, randomized, double‐blind trial with placebo‐control through week 24 followed by an open‐label extension of golimumab 50/100 mg treatment up to 5 years. In these post‐hoc analyses, MDA was defined by the presence of ≥5 of 7 PsA outcome measures (≤1 swollen joint, ≤1 tender joint, Psoriasis Area and Severity Index [PASI] ≤1, patient pain score ≤15, patient global disease activity score ≤20 [range 0–100], Health Assessment Questionnaire disability index [HAQ DI] ≤0.5, and ≤1 tender enthesis point). RESULTS: Treatment with golimumab yielded significantly higher MDA response rates versus patients randomized to placebo at week 14 (23.5% versus 1.0%; P < 0.0001), week 24 (28.1% versus 7.7%; P < 0.0001), and week 52 (42.4% versus 30.2%; P = 0.037). MDA was achieved at least once by ∼50% of golimumab‐treated patients overall. Irrespective of treatment randomization, achievement of MDA at ≥3 and ≥4 consecutive visits was associated with significantly less radiographic progression and more improvement in MDA components allowing specific assessment of physical function (HAQ DI) and overall disease activity (patient global assessment of disease activity) at week 256 versus patients not achieving MDA. Logistic regression analyses indicated that a 1‐unit higher baseline HAQ DI score yielded a significantly lower likelihood of achieving MDA at ≥3 (odds ratio 0.514 [95% confidence interval 0.321–0.824]; P = 0.006) and ≥4 (odds ratio 0.480 [95% confidence interval 0.290–0.795]; P = 0.004) consecutive visits. CONCLUSION: Among golimumab‐treated PsA patients, better long‐term functional improvement, patient global assessment, and radiographic outcomes were observed when patients achieved persistent MDA. |
format | Online Article Text |
id | pubmed-5066795 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-50667952016-11-01 Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study Kavanaugh, Arthur van der Heijde, Désirée Beutler, Anna Gladman, Dafna Mease, Philip Krueger, Gerald G. McInnes, Iain B. Helliwell, Philip Coates, Laura C. Xu, Stephen Arthritis Care Res (Hoboken) Psoriatic Arthritis OBJECTIVE: To evaluate long‐term outcomes in psoriatic arthritis (PsA) patients who achieved or did not achieve minimal disease activity (MDA) through 5 years of golimumab treatment in the GO‐REVEAL trial. METHODS: The GO‐REVEAL trial was a phase III, randomized, double‐blind trial with placebo‐control through week 24 followed by an open‐label extension of golimumab 50/100 mg treatment up to 5 years. In these post‐hoc analyses, MDA was defined by the presence of ≥5 of 7 PsA outcome measures (≤1 swollen joint, ≤1 tender joint, Psoriasis Area and Severity Index [PASI] ≤1, patient pain score ≤15, patient global disease activity score ≤20 [range 0–100], Health Assessment Questionnaire disability index [HAQ DI] ≤0.5, and ≤1 tender enthesis point). RESULTS: Treatment with golimumab yielded significantly higher MDA response rates versus patients randomized to placebo at week 14 (23.5% versus 1.0%; P < 0.0001), week 24 (28.1% versus 7.7%; P < 0.0001), and week 52 (42.4% versus 30.2%; P = 0.037). MDA was achieved at least once by ∼50% of golimumab‐treated patients overall. Irrespective of treatment randomization, achievement of MDA at ≥3 and ≥4 consecutive visits was associated with significantly less radiographic progression and more improvement in MDA components allowing specific assessment of physical function (HAQ DI) and overall disease activity (patient global assessment of disease activity) at week 256 versus patients not achieving MDA. Logistic regression analyses indicated that a 1‐unit higher baseline HAQ DI score yielded a significantly lower likelihood of achieving MDA at ≥3 (odds ratio 0.514 [95% confidence interval 0.321–0.824]; P = 0.006) and ≥4 (odds ratio 0.480 [95% confidence interval 0.290–0.795]; P = 0.004) consecutive visits. CONCLUSION: Among golimumab‐treated PsA patients, better long‐term functional improvement, patient global assessment, and radiographic outcomes were observed when patients achieved persistent MDA. John Wiley and Sons Inc. 2016-02 2016-01-25 /pmc/articles/PMC5066795/ /pubmed/25779603 http://dx.doi.org/10.1002/acr.22576 Text en © 2016 The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Psoriatic Arthritis Kavanaugh, Arthur van der Heijde, Désirée Beutler, Anna Gladman, Dafna Mease, Philip Krueger, Gerald G. McInnes, Iain B. Helliwell, Philip Coates, Laura C. Xu, Stephen Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study |
title | Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study |
title_full | Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study |
title_fullStr | Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study |
title_full_unstemmed | Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study |
title_short | Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study |
title_sort | radiographic progression of patients with psoriatic arthritis who achieve minimal disease activity in response to golimumab therapy: results through 5 years of a randomized, placebo‐controlled study |
topic | Psoriatic Arthritis |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5066795/ https://www.ncbi.nlm.nih.gov/pubmed/25779603 http://dx.doi.org/10.1002/acr.22576 |
work_keys_str_mv | AT kavanaugharthur radiographicprogressionofpatientswithpsoriaticarthritiswhoachieveminimaldiseaseactivityinresponsetogolimumabtherapyresultsthrough5yearsofarandomizedplacebocontrolledstudy AT vanderheijdedesiree radiographicprogressionofpatientswithpsoriaticarthritiswhoachieveminimaldiseaseactivityinresponsetogolimumabtherapyresultsthrough5yearsofarandomizedplacebocontrolledstudy AT beutleranna radiographicprogressionofpatientswithpsoriaticarthritiswhoachieveminimaldiseaseactivityinresponsetogolimumabtherapyresultsthrough5yearsofarandomizedplacebocontrolledstudy AT gladmandafna radiographicprogressionofpatientswithpsoriaticarthritiswhoachieveminimaldiseaseactivityinresponsetogolimumabtherapyresultsthrough5yearsofarandomizedplacebocontrolledstudy AT measephilip radiographicprogressionofpatientswithpsoriaticarthritiswhoachieveminimaldiseaseactivityinresponsetogolimumabtherapyresultsthrough5yearsofarandomizedplacebocontrolledstudy AT kruegergeraldg radiographicprogressionofpatientswithpsoriaticarthritiswhoachieveminimaldiseaseactivityinresponsetogolimumabtherapyresultsthrough5yearsofarandomizedplacebocontrolledstudy AT mcinnesiainb radiographicprogressionofpatientswithpsoriaticarthritiswhoachieveminimaldiseaseactivityinresponsetogolimumabtherapyresultsthrough5yearsofarandomizedplacebocontrolledstudy AT helliwellphilip radiographicprogressionofpatientswithpsoriaticarthritiswhoachieveminimaldiseaseactivityinresponsetogolimumabtherapyresultsthrough5yearsofarandomizedplacebocontrolledstudy AT coateslaurac radiographicprogressionofpatientswithpsoriaticarthritiswhoachieveminimaldiseaseactivityinresponsetogolimumabtherapyresultsthrough5yearsofarandomizedplacebocontrolledstudy AT xustephen radiographicprogressionofpatientswithpsoriaticarthritiswhoachieveminimaldiseaseactivityinresponsetogolimumabtherapyresultsthrough5yearsofarandomizedplacebocontrolledstudy |