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Satisfaction with Subcutaneous Golimumab and its Auto-Injector among Rheumatoid Arthritis Patients with Inadequate Response to Adalimumab or Etanercept

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Dehoratius RJ1,2, Brent LH3, Curtis JR4,5, Ellis LA1, Tang KL6. Patient. 2018 Feb 9. doi: 10.1007/s40271-018-0297-5. [Epub ahead of print]

Abstract

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1 Janssen Scientific Affairs, Horsham, PA, USA.

2 Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.

3 Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.

4 University of Alabama at Birmingham, Birmingham, AL, USA. jcurtis@uab.edu.

5 University of Alabama at Birmingham, Faculty Offices Tower, Room 802, 510 20th Street South, Birmingham, AL, 35294, USA. jcurtis@uab.edu.

6 Janssen Research and Development, Spring House, PA, USA.

Abstract

BACKGROUND: Patient perceptions of treatment success, including satisfaction/preference, may complement clinical efficacy assessments.

OBJECTIVE: Our objective was to evaluate satisfaction with subcutaneous golimumab and its auto-injector in patients with rheumatoid arthritis (RA) and an inadequate adalimumab/etanercept response.

METHODS: In the multicenter, assessor-blinded GO-SAVE study, 433 patients with active RA (28-joint Disease Activity Score incorporating erythrocyte sedimentation rate [DAS28-ESR] ≥ 3.6 and six or more swollen and six or more tender joints) despite methotrexate and past adalimumab/etanercept treatment received open-label subcutaneous golimumab 50 mg every 4 weeks (q4w) through week 12. Week 16 responders (DAS28-ESR improvement from baseline > 1.2 and score ≤ 3.2) continued therapy through week 52; nonresponders were randomized (1:2) to double-blind subcutaneous golimumab 50 mg q4w or intravenous golimumab 2 mg/kg [weeks 16, 20, every 8 weeks (q8w)]. Patients rated satisfaction with their injection experience on a 5-point scale (1 = very dissatisfied; 5 = very satisfied) at screening, week 8 (all enrolled patients), and week 44 (for patients continuing open-label subcutaneous golimumab 50 mg q4w). Discomfort, pain, stinging, burning, and redness related to injection were assessed (none, mild, moderate, severe).

RESULTS: Similar proportions of patients (N = 433) had most recently received adalimumab (50.3%) or etanercept (49.7%) prior to golimumab. Overall satisfaction (somewhat/very) with the golimumab injection experience was reported by 84.4% of patients at week 8 versus 63.4% of patients who were satisfied with prior adalimumab/etanercept. Patients receiving open-label subcutaneous golimumab through week 44 (N = 75) reported much less discomfort (60.9%), redness (60.9%), pain (59.4%), stinging (67.2%), and burning (65.6%) with the golimumab injection than with their previous tumor necrosis factor antagonist medication injection.

CONCLUSION: Most patients with RA receiving golimumab following adalimumab/etanercept inadequate response were satisfied with their overall golimumab experience, including its auto-injector versus their previous injection device. CLINICAL TRIALS.GOV: NCT01004432; EudraCT 2009-010582-23.