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Arthritis & Rheumatology
Article . 2017 . Peer-reviewed
License: CC BY NC ND
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Arthritis & Rheumatology
Article
License: CC BY NC ND
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PubMed Central
Article . 2017
Data sources: PubMed Central
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Safety and Efficacy of Intravenous Golimumab in Patients With Active Psoriatic Arthritis

Results Through Week Twenty‐Four of the GO‐VIBRANT Study
Authors: Kavanaugh, Arthur; Husni, M. Elaine; Harrison, Diane D.; Kim, Lilianne; Lo, Kim Hung; Leu, Jocelyn H.; Hsia, Elizabeth C.;

Safety and Efficacy of Intravenous Golimumab in Patients With Active Psoriatic Arthritis

Abstract

Objective To evaluate the safety and efficacy of intravenous ( IV ) golimumab treatment in psoriatic arthritis (PsA). Methods In this phase III , randomized, double‐blind, placebo‐controlled trial, patients were randomly assigned to receive IV placebo (n = 239) or golimumab at 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR 20 response) at week 14. Controlled secondary end points included change from baseline in Health Assessment Questionnaire disability index ( HAQ DI ) score at week 14, proportions of patients with ACR 50 and ACR 70 responses and ≥75% improvement on the Psoriasis Area and Severity Index (a PASI 75 response) at week 14, and change from baseline at week 24 in the total modified Sharp/van der Heijde score ( SHS ) with modifications for patients with PsA. Results At week 14, an ACR 20 response was achieved by 75.1% of patients in the golimumab group compared with 21.8% of patients in the placebo group ( P < 0.001). Greater proportions of golimumab‐treated patients had an ACR 50 response (43.6% versus 6.3%), an ACR 70 response (24.5% versus 2.1%), and a PASI 75 response (59.2% versus 13.6%) at week 14 ( P < 0.001 for all). Patients in the golimumab group had greater mean changes at week 14 in HAQ DI score (–0.60 versus –0.12; P < 0.001). At week 24, the mean change in total PsA‐modified SHS was –0.4 in the golimumab group and 2.0 in the placebo group ( P < 0.001). Through week 24, 40.6% of patients in the placebo group and 46.3% of patients in the golimumab group had ≥1 adverse event ( AE ); infections were the most common type. Conclusion Patients receiving IV golimumab at 2 mg/kg had significantly greater improvements in the signs and symptoms of PsA and less radiographic progression through week 24. AE s were consistent with those seen with other anti–tumor necrosis factor agents.

Keywords

Adult, Male, Psoriatic Arthritis, Anti-Inflammatory Agents, Non-Steroidal, Arthritis, Psoriatic, Antibodies, Monoclonal, Middle Aged, Opportunistic Infections, Methotrexate, Treatment Outcome, Double-Blind Method, Antirheumatic Agents, Neoplasms, Humans, Drug Therapy, Combination, Female, Patient Reported Outcome Measures, Infusions, Intravenous, Glucocorticoids, Demyelinating Diseases

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    popularity
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    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 1%
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
108
Top 1%
Top 10%
Top 1%
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