Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study). Kavanaugh, A., McInnes, I. B, Mease, P., Krueger, G. G, Gladman, D., van der Heijde, D., Zhou, Y., Lu, J., Leu, J. H, Goldstein, N., & Beutler, A. Annals of the Rheumatic Diseases, 73(9):1689–1694, September, 2014.
Paper doi abstract bibtex Objectives Assess golimumab’s long-term efficacy/ safety in psoriatic arthritis (PsA). Methods Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-proteinbased, 28-joint-count Disease Activity Score (DAS28CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs). Results 126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8–69.9%, DAS28-CRP: 75.2-84.9% for randomised patients; PASI75: 60.8–72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1–0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate). Conclusions Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years. Trial registration number NCT00265096.
@article{kavanaugh_clinical_2014-5,
title = {Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the {GO}-{REVEAL} study)},
volume = {73},
issn = {0003-4967, 1468-2060},
shorttitle = {Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis},
url = {https://ard.bmj.com/lookup/doi/10.1136/annrheumdis-2013-204902},
doi = {10.1136/annrheumdis-2013-204902},
abstract = {Objectives Assess golimumab’s long-term efficacy/ safety in psoriatic arthritis (PsA). Methods Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20\% improvement in American College of Rheumatology (ACR20) response, C-reactive-proteinbased, 28-joint-count Disease Activity Score (DAS28CRP) response, ≥75\% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs). Results 126/405 (31\%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8–69.9\%, DAS28-CRP: 75.2-84.9\% for randomised patients; PASI75: 60.8–72.2\% among randomised patients with ≥3\% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1–0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8\%/10.0\% of patients with/without methotrexate). Conclusions Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years. Trial registration number NCT00265096.},
language = {en},
number = {9},
urldate = {2022-03-09},
journal = {Annals of the Rheumatic Diseases},
author = {Kavanaugh, Arthur and McInnes, Iain B and Mease, Philip and Krueger, Gerald G and Gladman, Dafna and van der Heijde, Désirée and Zhou, Yiying and Lu, Jiandong and Leu, Jocelyn H and Goldstein, Neil and Beutler, Anna},
month = sep,
year = {2014},
pages = {1689--1694},
file = {Kavanaugh et al. - 2014 - Clinical efficacy, radiographic and safety finding.pdf:/Users/neil.hawkins/Zotero/storage/KYRKK26I/Kavanaugh et al. - 2014 - Clinical efficacy, radiographic and safety finding.pdf:application/pdf},
}
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H","Goldstein, N.","Beutler, A."],"bibdata":{"bibtype":"article","type":"article","title":"Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study)","volume":"73","issn":"0003-4967, 1468-2060","shorttitle":"Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis","url":"https://ard.bmj.com/lookup/doi/10.1136/annrheumdis-2013-204902","doi":"10.1136/annrheumdis-2013-204902","abstract":"Objectives Assess golimumab’s long-term efficacy/ safety in psoriatic arthritis (PsA). Methods Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-proteinbased, 28-joint-count Disease Activity Score (DAS28CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs). Results 126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8–69.9%, DAS28-CRP: 75.2-84.9% for randomised patients; PASI75: 60.8–72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1–0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate). Conclusions Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years. Trial registration number NCT00265096.","language":"en","number":"9","urldate":"2022-03-09","journal":"Annals of the Rheumatic Diseases","author":[{"propositions":[],"lastnames":["Kavanaugh"],"firstnames":["Arthur"],"suffixes":[]},{"propositions":[],"lastnames":["McInnes"],"firstnames":["Iain","B"],"suffixes":[]},{"propositions":[],"lastnames":["Mease"],"firstnames":["Philip"],"suffixes":[]},{"propositions":[],"lastnames":["Krueger"],"firstnames":["Gerald","G"],"suffixes":[]},{"propositions":[],"lastnames":["Gladman"],"firstnames":["Dafna"],"suffixes":[]},{"propositions":["van","der"],"lastnames":["Heijde"],"firstnames":["Désirée"],"suffixes":[]},{"propositions":[],"lastnames":["Zhou"],"firstnames":["Yiying"],"suffixes":[]},{"propositions":[],"lastnames":["Lu"],"firstnames":["Jiandong"],"suffixes":[]},{"propositions":[],"lastnames":["Leu"],"firstnames":["Jocelyn","H"],"suffixes":[]},{"propositions":[],"lastnames":["Goldstein"],"firstnames":["Neil"],"suffixes":[]},{"propositions":[],"lastnames":["Beutler"],"firstnames":["Anna"],"suffixes":[]}],"month":"September","year":"2014","pages":"1689–1694","file":"Kavanaugh et al. - 2014 - Clinical efficacy, radiographic and safety finding.pdf:/Users/neil.hawkins/Zotero/storage/KYRKK26I/Kavanaugh et al. - 2014 - Clinical efficacy, radiographic and safety finding.pdf:application/pdf","bibtex":"@article{kavanaugh_clinical_2014-5,\n\ttitle = {Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the {GO}-{REVEAL} study)},\n\tvolume = {73},\n\tissn = {0003-4967, 1468-2060},\n\tshorttitle = {Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis},\n\turl = {https://ard.bmj.com/lookup/doi/10.1136/annrheumdis-2013-204902},\n\tdoi = {10.1136/annrheumdis-2013-204902},\n\tabstract = {Objectives Assess golimumab’s long-term efficacy/ safety in psoriatic arthritis (PsA). Methods Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20\\% improvement in American College of Rheumatology (ACR20) response, C-reactive-proteinbased, 28-joint-count Disease Activity Score (DAS28CRP) response, ≥75\\% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs). Results 126/405 (31\\%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8–69.9\\%, DAS28-CRP: 75.2-84.9\\% for randomised patients; PASI75: 60.8–72.2\\% among randomised patients with ≥3\\% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1–0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8\\%/10.0\\% of patients with/without methotrexate). Conclusions Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years. 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