Hendrik Schulze-Koops1, Roberto Giacomelli2, Wlodzimierz Samborski3, Simona Rednic4, Manfred Herold5, Ruji Yao6, Marinella Govoni7, Nathan Vastesaeger8, Haoling H Weng6. 1. Division of Rheumatology, Department of Internal Medicine IV, University of Munich, Munich, Germany. 2. University of L'Aquila, L'Aquila, Italy. 3. Ortopedyczno-Rehabilitacyjny Szpital Kliniczny, Poznań, Wielkopolskie, Poland. 4. University of Medicine and Pharmacy, Cluj-Napoca, Romania. 5. Medical University of Innsbruck, Innsbruck, Austria. 6. Merck & Co., Inc., Whitehouse Station, NJ, USA. 7. MSD Italy, Rome, Italy. 8. MSD Belgium, Brussels, Belgium.
Abstract
OBJECTIVES: To evaluate factors influencing injection patterns and patient evaluations of an autoinjector device in biologic-naïve patients beginning golimumab (GLM) treatment. METHODS: GO-MORE was an open-label, multinational, prospective study in patients with active rheumatoid arthritis (RA) (28-joint disease activity score based on erythrocyte sedimentation rate [DAS28-ESR] ≥3.2). Patients injected 50 mg subcutaneous GLM once monthly for 6 months. Patients reported use preferences and autoinjector evaluations by questionnaire. Responses were analysed descriptively. Effects of patient variables were evaluated with chi-square tests or t-tests. RESULTS: Of 3,280 efficacy-evaluable patients, 67.7% self-injected with the autoinjector. Compared with patients who self-injected, patients who had someone else administer injections had greater baseline disease activity (e.g., DAS28-ESR 5.84 vs. 6.23, respectively), but not more tender/swollen joints in hands/wrists. Month 6 efficacy was greater for patients who self-injected. In those who self-injected, injection site (thigh [75.2%; 1,563/2,077], abdomen [17.4%; 363/2,077], upper arm [7.2%; 151/2,077]) was not associated with wrist swelling or tender/swollen joints in the hand used for injection. Autoinjector ratings were similar across injection sites, yet less pain/discomfort was associated with abdomen injection. Patient autoinjector ratings were favourable overall (e.g. ease of use, pain). Patients with baseline functional impairment had slightly less favourable ratings. CONCLUSIONS: Biologic-naïve patients who self-injected had less baseline disease activity and higher response rates than patients who did not self-inject. Although patients prefer to inject in the thigh, injection in the belly may be less painful. Most patients who self-injected had favourable autoinjector evaluations; patients with functional impairment had slightly less favourable ratings.
OBJECTIVES: To evaluate factors influencing injection patterns and patient evaluations of an autoinjector device in biologic-naïve patients beginning golimumab (GLM) treatment. METHODS: GO-MORE was an open-label, multinational, prospective study in patients with active rheumatoid arthritis (RA) (28-joint disease activity score based on erythrocyte sedimentation rate [DAS28-ESR] ≥3.2). Patients injected 50 mg subcutaneous GLM once monthly for 6 months. Patients reported use preferences and autoinjector evaluations by questionnaire. Responses were analysed descriptively. Effects of patient variables were evaluated with chi-square tests or t-tests. RESULTS: Of 3,280 efficacy-evaluable patients, 67.7% self-injected with the autoinjector. Compared with patients who self-injected, patients who had someone else administer injections had greater baseline disease activity (e.g., DAS28-ESR 5.84 vs. 6.23, respectively), but not more tender/swollen joints in hands/wrists. Month 6 efficacy was greater for patients who self-injected. In those who self-injected, injection site (thigh [75.2%; 1,563/2,077], abdomen [17.4%; 363/2,077], upper arm [7.2%; 151/2,077]) was not associated with wrist swelling or tender/swollen joints in the hand used for injection. Autoinjector ratings were similar across injection sites, yet less pain/discomfort was associated with abdomen injection. Patient autoinjector ratings were favourable overall (e.g. ease of use, pain). Patients with baseline functional impairment had slightly less favourable ratings. CONCLUSIONS: Biologic-naïve patients who self-injected had less baseline disease activity and higher response rates than patients who did not self-inject. Although patients prefer to inject in the thigh, injection in the belly may be less painful. Most patients who self-injected had favourable autoinjector evaluations; patients with functional impairment had slightly less favourable ratings.
Authors: Karin Luttropp; Mary Dozier; Nahila Justo; Freddy Cornillie; Sumesh Kachroo; Marinella Govoni; Stina Salomonsson; Christopher M Black; Ahmed Khalifa Journal: BMJ Open Date: 2019-05-28 Impact factor: 2.692
Authors: Saira Z Sheikh; Anne E Hammer; Norma Lynn Fox; James Groark; Herbert Struemper; David Roth; David Gordon Journal: Int J Clin Pharmacol Ther Date: 2016-11 Impact factor: 1.366