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)

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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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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