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ACR open rheumatology
Nov, 2020;2 (11): 640-647.

Evaluation of Improvement in Skin and Nail Psoriasis in Bio-naïve Patients With Active Psoriatic Arthritis Treated With Golimumab: Results Through Week 52 of the GO-VIBRANT Study.

Philip Mease, M Elaine Husni, Soumya D Chakravarty, Shelly Kafka, Dennis Parenti, Lilianne Kim, Kim Hung Lo, Elizabeth C Hsia, Arthur Kavanaugh
Author Information
  1. Philip Mease: Swedish Medical Center, Seattle, Washington and University of Washington School of Medicine, Seattle. ORCID
  2. M Elaine Husni: Cleveland Clinic, Cleveland, Ohio. ORCID
  3. Soumya D Chakravarty: Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, and, Drexel University College of Medicine, Philadelphia, PA. ORCID
  4. Shelly Kafka: Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.
  5. Dennis Parenti: Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.
  6. Lilianne Kim: Janssen Research & Development, LLC, Spring House, Pennsylvania.
  7. Kim Hung Lo: Janssen Research & Development, LLC, Spring House, Pennsylvania.
  8. Elizabeth C Hsia: Janssen Research & Development, LLC, Spring House, Pennsylvania, and University of Pennsylvania, Philadelphia.
  9. Arthur Kavanaugh: University of California, San Diego.
PMID: 33073933 DOI: 10.1002/acr2.11180

Abstract

OBJECTIVE: To evaluate whether intravenous (IV) golimumab produces improvements in skin and nail symptoms that are concomitant with improvements in quality of life (QoL) and joint symptoms in patients with psoriatic arthritis.
METHODS: Patients were randomized to either IV golimumab 2 mg/kg at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo at weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52. Assessments included Psoriasis Area and Severity Index (PASI), modified Nail Psoriasis Severity Index (mNAPSI), Dermatology Life Quality Index (DLQI), and American College of Rheumatology (ACR) rheumatoid arthritis response criteria.
RESULTS: Through week 24, achievement of PASI 75/90/100 responses (P ≤ .0098) and mean improvements in mNAPSI (-11.4 vs -3.7; P < .0001) and DLQI (-9.8 vs -2.9; P < .0001) were significantly greater with golimumab versus placebo. Responses were maintained in patients treated with golimumab through week 52. In placebo-crossover patients, increases in the proportion of patients achieving PASI 75/90/100 responses were observed from weeks 24 to 52, and mean improvements in mNAPSI (from -3.7 to -12.9) and DLQI (from -2.9 to -7.8) increased from weeks 24 to 52. Simultaneous achievement of PASI and DLQI responses, PASI and ACR responses, and mNAPSI and DLQI responses were also observed. Similar responses were observed for all assessments regardless of concomitant methotrexate use.
CONCLUSION: Improvements in skin and nail psoriasis symptoms with IV golimumab in patients with psoriatic arthritis were concomitant with improvements in QoL and arthritis disease activity through 1 year.

Keywords

DLQI intravenous golimumab mNAPSI psoriasis psoriatic arthritis

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  1. /Janssen Research & Development, LLC
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