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

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.

SUBMITTER: Dehoratius RJ

PROVIDER: S-EPMC5948248 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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

Dehoratius Raphael J RJ Brent Lawrence H LH Curtis Jeffrey R JR Ellis Lorie A LA Tang Kezhen L KL

The patient 20180601 3

<h4>Background</h4>Patient perceptions of treatment success, including satisfaction/preference, may complement clinical efficacy assessments.<h4>Objective</h4>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.<h4>Methods</h4>In the multicenter, assessor-blinded GO-SAVE study, 433 patients with active RA (28-joint Disease Activity Score incorporating erythrocyte s ...[more]

PMID: 29427176

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Project description:INTRODUCTION:Etanercept is effective in the management of rheumatoid arthritis (RA) and can be self-administered via an auto-injector. While these devices are generally well accepted, some patients are not comfortable with the process of self-administration; this has been cited as a reason for discontinuation of biologic treatment. Alternative routes of administration (e.g., infusion) are more resource intensive. The aim of this analysis was to explore the attributes of auto-injection devices that impact patient confidence and ability to self-administer. METHODS:Patients with RA (n = 168) and healthcare providers (n = 82) in Belgium, Germany, Japan, Spain, and the UK were interviewed (n = 250 overall). Mock injection procedures were carried out using an auto-injector device with the addition of a sleeve with a wider rubber grip. Importance of and performance of the device against a range attributes were captured using a Likert scale (1-7). Disease severity was captured using the Cochin hand function scale. RESULTS:Device attributes reported by patients to be most important were 'use without assistance' 'ease of administration', 'ease of operation', and 'ease of grip'. The device with additional sleeve performed strongly against these attributes, scoring 6.9 (out of 7), 6.8, 6.8, and 6.6, respectively with no difference observed between countries. Nurses and physicians reported similar responses. Qualitatively, patients reported that stability and grip provided a sense of control and reduced anxiety. Similar overall 'ease of operation' was reported between patients with mild (n = 89) or moderate/severe (n = 71) disease (score 6.4 vs. 6.5, respectively). CONCLUSIONS:The auto-injector plus sleeve performed strongly against key attributes even in patients with moderate/severe RA and patients with reduced grip strength. The robust grip improved patient confidence and reduced injection-related anxiety. This may be beneficial in patients who are anxious about self-administration, those new to self-administration, and potentially in patients with reduced hand dexterity as a result of either advanced disease or a painful day.

Project description:To assess joint disease activity by ultrasound (US) in patients with rheumatoid arthritis (RA) initiating treatment with adalimumab (ADA) plus methotrexate (MTX).Data for this post hoc analysis originated from the MUSICA trial (ClinicalTrials.gov identifier: NCT01185288), which evaluated the efficacy of initiating ADA (40 mg every other week) plus 7.5 or 20 mg/week MTX in 309 patients with RA with an inadequate response to MTX. Synovial vascularization over 24 weeks was assessed bilaterally at metacarpophalangeal joint 2 (MCP2), MCP3, MCP5, metatarsophalangeal joint 5, and the wrists by power Doppler US (PDUS). A semiquantitative 4-grade scale was used. Disease activity was assessed using the Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP) and Simplified Disease Activity Index (SDAI). The correlation between continuous variables was assessed using Pearson's correlation coefficient.After 24 weeks of treatment with ADA plus MTX, rapid improvements in the mean synovial vascularity score were observed; the greatest improvements were in MCP2 (-0.5), MCP3 (-0.4), and the wrist (-0.4). At week 24, patients with the lowest DAS28-CRP (<2.6) had the lowest mean 5-joint and 3-joint composite synovial vascularity scores. The 5-joint and 3-joint scores were strongly correlated (??>?0.9). Synovial vascularity scores correlated poorly with DAS28, swollen joint count in 66 joints (SJC66), SJC28, tender joint count in 68 joints (TJC68), TJC28, Clinical Disease Activity Index (CDAI), SDAI, physician's global assessment, patient's global assessment of pain, and disease duration (??<?0.2). Thirty-two (70%) of 46 patients with a DAS28-CRP of <2.6, and 11 (58%) of 19 patients with an SDAI indicating remission had at least 1 joint with a synovial vascularity score of ?1.PDUS detects changes in synovial vascularity in RA patients treated with ADA plus MTX, and residual synovial vascularity in patients in whom clinical disease control has been achieved.

Dataset Information

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

Publications

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

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