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Research ArticleArticle
Open Access

Radiographic Progression Inhibition with Intravenous Golimumab in Psoriatic Arthritis: Week 24 Results of a Phase III, Randomized, Double-blind, Placebo-controlled Trial

Arthur Kavanaugh, M. Elaine Husni, Diane D. Harrison, Lilianne Kim, Kim Hung Lo, Lenore Noonan and Elizabeth C. Hsia
The Journal of Rheumatology February 2019, jrheum.180681; DOI: https://doi.org/10.3899/jrheum.180681
Arthur Kavanaugh
From Internal Medicine — Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine — Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Janssen Research & Development LLC funded this study. Janssen Biotech Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, manufactures golimumab. Authors who are employees of the study sponsor were involved in the study design, collecting and analyzing the data, and interpreting the results. Writing support was provided by Janssen Scientific Affairs LLC. Janssen Research & Development LLC approved the content of the article; the authors made the decision to submit for publication. Drs. Harrison and Hsia, and L. Kim, K.H. Lo, and L. Noonan are employees of Janssen Research & Development LLC and own stock or stock options in Johnson & Johnson, of which Janssen Research & Development LLC is a wholly owned subsidiary. A. Kavanaugh, MD, Internal Medicine — Rheumatology, University of California at San Diego; M.E. Husni, MD, MPH, Internal Medicine — Rheumatology, Cleveland Clinic; D.D. Harrison, MD, MPH, Immunology, Janssen Research & Development LLC; L. Kim, PhD, Immunology, Janssen Research & Development LLC; K.H. Lo, PhD, Immunology, Janssen Research & Development LLC; L. Noonan, RT(MR), Immunology, Janssen Research & Development LLC; E.C. Hsia, MD, MSCE, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania. Address correspondence to Dr. E.C. Hsia, Janssen Research & Development LLC, 1400 McKean Road, PO Box 776, Spring House, Pennsylvania 19477, USA. E-mail: ehsia@its.jnj.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication October 18, 2018.
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M. Elaine Husni
From Internal Medicine — Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine — Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Janssen Research & Development LLC funded this study. Janssen Biotech Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, manufactures golimumab. Authors who are employees of the study sponsor were involved in the study design, collecting and analyzing the data, and interpreting the results. Writing support was provided by Janssen Scientific Affairs LLC. Janssen Research & Development LLC approved the content of the article; the authors made the decision to submit for publication. Drs. Harrison and Hsia, and L. Kim, K.H. Lo, and L. Noonan are employees of Janssen Research & Development LLC and own stock or stock options in Johnson & Johnson, of which Janssen Research & Development LLC is a wholly owned subsidiary. A. Kavanaugh, MD, Internal Medicine — Rheumatology, University of California at San Diego; M.E. Husni, MD, MPH, Internal Medicine — Rheumatology, Cleveland Clinic; D.D. Harrison, MD, MPH, Immunology, Janssen Research & Development LLC; L. Kim, PhD, Immunology, Janssen Research & Development LLC; K.H. Lo, PhD, Immunology, Janssen Research & Development LLC; L. Noonan, RT(MR), Immunology, Janssen Research & Development LLC; E.C. Hsia, MD, MSCE, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania. Address correspondence to Dr. E.C. Hsia, Janssen Research & Development LLC, 1400 McKean Road, PO Box 776, Spring House, Pennsylvania 19477, USA. E-mail: ehsia@its.jnj.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication October 18, 2018.
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Diane D. Harrison
From Internal Medicine — Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine — Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Janssen Research & Development LLC funded this study. Janssen Biotech Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, manufactures golimumab. Authors who are employees of the study sponsor were involved in the study design, collecting and analyzing the data, and interpreting the results. Writing support was provided by Janssen Scientific Affairs LLC. Janssen Research & Development LLC approved the content of the article; the authors made the decision to submit for publication. Drs. Harrison and Hsia, and L. Kim, K.H. Lo, and L. Noonan are employees of Janssen Research & Development LLC and own stock or stock options in Johnson & Johnson, of which Janssen Research & Development LLC is a wholly owned subsidiary. A. Kavanaugh, MD, Internal Medicine — Rheumatology, University of California at San Diego; M.E. Husni, MD, MPH, Internal Medicine — Rheumatology, Cleveland Clinic; D.D. Harrison, MD, MPH, Immunology, Janssen Research & Development LLC; L. Kim, PhD, Immunology, Janssen Research & Development LLC; K.H. Lo, PhD, Immunology, Janssen Research & Development LLC; L. Noonan, RT(MR), Immunology, Janssen Research & Development LLC; E.C. Hsia, MD, MSCE, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania. Address correspondence to Dr. E.C. Hsia, Janssen Research & Development LLC, 1400 McKean Road, PO Box 776, Spring House, Pennsylvania 19477, USA. E-mail: ehsia@its.jnj.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication October 18, 2018.
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Lilianne Kim
From Internal Medicine — Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine — Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Janssen Research & Development LLC funded this study. Janssen Biotech Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, manufactures golimumab. Authors who are employees of the study sponsor were involved in the study design, collecting and analyzing the data, and interpreting the results. Writing support was provided by Janssen Scientific Affairs LLC. Janssen Research & Development LLC approved the content of the article; the authors made the decision to submit for publication. Drs. Harrison and Hsia, and L. Kim, K.H. Lo, and L. Noonan are employees of Janssen Research & Development LLC and own stock or stock options in Johnson & Johnson, of which Janssen Research & Development LLC is a wholly owned subsidiary. A. Kavanaugh, MD, Internal Medicine — Rheumatology, University of California at San Diego; M.E. Husni, MD, MPH, Internal Medicine — Rheumatology, Cleveland Clinic; D.D. Harrison, MD, MPH, Immunology, Janssen Research & Development LLC; L. Kim, PhD, Immunology, Janssen Research & Development LLC; K.H. Lo, PhD, Immunology, Janssen Research & Development LLC; L. Noonan, RT(MR), Immunology, Janssen Research & Development LLC; E.C. Hsia, MD, MSCE, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania. Address correspondence to Dr. E.C. Hsia, Janssen Research & Development LLC, 1400 McKean Road, PO Box 776, Spring House, Pennsylvania 19477, USA. E-mail: ehsia@its.jnj.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication October 18, 2018.
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Kim Hung Lo
From Internal Medicine — Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine — Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Janssen Research & Development LLC funded this study. Janssen Biotech Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, manufactures golimumab. Authors who are employees of the study sponsor were involved in the study design, collecting and analyzing the data, and interpreting the results. Writing support was provided by Janssen Scientific Affairs LLC. Janssen Research & Development LLC approved the content of the article; the authors made the decision to submit for publication. Drs. Harrison and Hsia, and L. Kim, K.H. Lo, and L. Noonan are employees of Janssen Research & Development LLC and own stock or stock options in Johnson & Johnson, of which Janssen Research & Development LLC is a wholly owned subsidiary. A. Kavanaugh, MD, Internal Medicine — Rheumatology, University of California at San Diego; M.E. Husni, MD, MPH, Internal Medicine — Rheumatology, Cleveland Clinic; D.D. Harrison, MD, MPH, Immunology, Janssen Research & Development LLC; L. Kim, PhD, Immunology, Janssen Research & Development LLC; K.H. Lo, PhD, Immunology, Janssen Research & Development LLC; L. Noonan, RT(MR), Immunology, Janssen Research & Development LLC; E.C. Hsia, MD, MSCE, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania. Address correspondence to Dr. E.C. Hsia, Janssen Research & Development LLC, 1400 McKean Road, PO Box 776, Spring House, Pennsylvania 19477, USA. E-mail: ehsia@its.jnj.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication October 18, 2018.
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Lenore Noonan
From Internal Medicine — Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine — Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Janssen Research & Development LLC funded this study. Janssen Biotech Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, manufactures golimumab. Authors who are employees of the study sponsor were involved in the study design, collecting and analyzing the data, and interpreting the results. Writing support was provided by Janssen Scientific Affairs LLC. Janssen Research & Development LLC approved the content of the article; the authors made the decision to submit for publication. Drs. Harrison and Hsia, and L. Kim, K.H. Lo, and L. Noonan are employees of Janssen Research & Development LLC and own stock or stock options in Johnson & Johnson, of which Janssen Research & Development LLC is a wholly owned subsidiary. A. Kavanaugh, MD, Internal Medicine — Rheumatology, University of California at San Diego; M.E. Husni, MD, MPH, Internal Medicine — Rheumatology, Cleveland Clinic; D.D. Harrison, MD, MPH, Immunology, Janssen Research & Development LLC; L. Kim, PhD, Immunology, Janssen Research & Development LLC; K.H. Lo, PhD, Immunology, Janssen Research & Development LLC; L. Noonan, RT(MR), Immunology, Janssen Research & Development LLC; E.C. Hsia, MD, MSCE, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania. Address correspondence to Dr. E.C. Hsia, Janssen Research & Development LLC, 1400 McKean Road, PO Box 776, Spring House, Pennsylvania 19477, USA. E-mail: ehsia@its.jnj.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication October 18, 2018.
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Elizabeth C. Hsia
From Internal Medicine — Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine — Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Janssen Research & Development LLC funded this study. Janssen Biotech Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, manufactures golimumab. Authors who are employees of the study sponsor were involved in the study design, collecting and analyzing the data, and interpreting the results. Writing support was provided by Janssen Scientific Affairs LLC. Janssen Research & Development LLC approved the content of the article; the authors made the decision to submit for publication. Drs. Harrison and Hsia, and L. Kim, K.H. Lo, and L. Noonan are employees of Janssen Research & Development LLC and own stock or stock options in Johnson & Johnson, of which Janssen Research & Development LLC is a wholly owned subsidiary. A. Kavanaugh, MD, Internal Medicine — Rheumatology, University of California at San Diego; M.E. Husni, MD, MPH, Internal Medicine — Rheumatology, Cleveland Clinic; D.D. Harrison, MD, MPH, Immunology, Janssen Research & Development LLC; L. Kim, PhD, Immunology, Janssen Research & Development LLC; K.H. Lo, PhD, Immunology, Janssen Research & Development LLC; L. Noonan, RT(MR), Immunology, Janssen Research & Development LLC; E.C. Hsia, MD, MSCE, Immunology, Janssen Research & Development LLC, and Rheumatology, University of Pennsylvania. Address correspondence to Dr. E.C. Hsia, Janssen Research & Development LLC, 1400 McKean Road, PO Box 776, Spring House, Pennsylvania 19477, USA. E-mail: ehsia@its.jnj.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted for publication October 18, 2018.
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Abstract

Objective Evaluate effects of intravenous (IV) golimumab (GOL) on radiographic progression in psoriatic arthritis (PsA).

Methods This phase III, randomized, double-blind, placebo-controlled trial (GO-VIBRANT) randomized patients with active PsA to receive IV placebo (n = 239) or IV GOL 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. Radiographic progression (controlled secondary endpoint) was evaluated as change from baseline at Week 24 in PsA-modified total Sharp/van der Heijde scores (SvdH). The proportions of patients with a change from baseline at Week 24 in the total PsA-modified SvdH exceeding the smallest detectable change (SDC) or > 0 or 0.5 also were determined.

Results Overall, 474 patients (237/arm) contributed radiographic data. Results obtained from the 2 blinded, independent radiographic readers demonstrated good agreement (total score intraclass correlation coefficients: baseline = 0.93, Week 24 = 0.92, Week 24 change score = 0.73). GOL demonstrated significant inhibition of radiographic progression relative to placebo from baseline to Week 24 (mean changes in PsA-modified total SvdH: –0.36 vs 1.95; treatment difference: –2.32; p < 0.001). At Week 24, smaller proportions of GOL- versus placebo-treated patients demonstrated an increase in the total PsA-modified SvdH score exceeding the SDC (8.0% vs 27.0%, respectively; difference: –19.0%; p < 0.001), > 0 (28.3% vs 57.0%, respectively; difference: –28.7%; p < 0.001), or > 0.5 (18.6% vs 41.8%, respectively; difference: –23.2%; p < 0.001). Results were consistent for erosion and joint space narrowing scores, in hands and feet, and in patients with/without baseline concomitant methotrexate use. Prevention of radiographic progression by GOL was independent of clinical response.

Conclusion IV GOL is significantly better than placebo in inhibiting radiographic progression of structural damage in active PsA. [Clinical trial registration number (www.ClinicalTrials.gov): NCT02181673]

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Radiographic Progression Inhibition with Intravenous Golimumab in Psoriatic Arthritis: Week 24 Results of a Phase III, Randomized, Double-blind, Placebo-controlled Trial
Arthur Kavanaugh, M. Elaine Husni, Diane D. Harrison, Lilianne Kim, Kim Hung Lo, Lenore Noonan, Elizabeth C. Hsia
The Journal of Rheumatology Feb 2019, jrheum.180681; DOI: 10.3899/jrheum.180681

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Radiographic Progression Inhibition with Intravenous Golimumab in Psoriatic Arthritis: Week 24 Results of a Phase III, Randomized, Double-blind, Placebo-controlled Trial
Arthur Kavanaugh, M. Elaine Husni, Diane D. Harrison, Lilianne Kim, Kim Hung Lo, Lenore Noonan, Elizabeth C. Hsia
The Journal of Rheumatology Feb 2019, jrheum.180681; DOI: 10.3899/jrheum.180681
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