Clinical Assessment of Pain, Tolerability, and Preference of an Autoinjection Pen Versus a Prefilled Syringe for Patient Self-Administration of the Fully Human, Monoclonal Antibody Adalimumab: The TOUCH Trial

Adalimumab is a therapeutic monoclonal antibody for SC administration by 2 single-use injection devices providing bioequivalent amounts of adalimumab: a ready-to-use, prefilled syringe and an integrated, disposable delivery system, the autoinjection Pen. Although pens have been shown to be preferred...

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Bibliographic Details
Published in:	Clinical therapeutics Vol. 28; no. 10; pp. 1619 - 1629
Main Authors:	Kivitz, Alan, Cohen, Steven, Dowd, James Edward, Edwards, William, Thakker, Suman, Wellborne, Frank R., Renz, Cheryl L., Segurado, Oscar G.
Format:	Journal Article
Language:	English
Published:	Belle Mead, NJ EM Inc USA 01-10-2006 Excerpta Medica Elsevier Limited
Subjects:	Adalimumab Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Antirheumatic Agents - administration & dosage Antirheumatic Agents - adverse effects Antirheumatic Agents - therapeutic use Biological and medical sciences Diabetes Humans Insulin Laboratories Medical sciences Monoclonal antibodies Pain - etiology Patient Compliance Pharmacology. Drug treatments prefilled syringe, autoinjection pen, adalimumab, TNF antagonist, patient preference Rheumatoid arthritis Self Administration Syringes Tumor necrosis factor-TNF United States > US Texas Michigan prefilled syringe, autoinjection pen, adalimumab, TNF antagonist, patient preference Human Evaluation Toxicity Cytokine Antipsoriatic agent Patient Monoclonal antibody Self administration prefilled syringe Immunomodulator patient preference Pain autoinjection pen Tumor necrosis factor Preference Anticytokine Syringe Clinical trial Antagonist Adalimumab TNF antagonist Tumor necrosis factor α Comparative study
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Summary:	Adalimumab is a therapeutic monoclonal antibody for SC administration by 2 single-use injection devices providing bioequivalent amounts of adalimumab: a ready-to-use, prefilled syringe and an integrated, disposable delivery system, the autoinjection Pen. Although pens have been shown to be preferred over syringes by patients requiring long-term SC administration of medications, there are no data on preference and pain in the use of biologics in patients with chronic inflammatory diseases. The aim of this study was to assess injection-site pain, tolerability, and patient preference of 2 delivery systems of adalimumab. Patients with rheumatoid arthritis were enrolled in a Phase II, multicenter, open-label, singlearm, sequential trial. Patients self-administered a standard dose of adalimumab 40 mg SC every other week at each of 3 monitored clinical visits: visit 1 (syringe), visits 2 and 3 (Pen). At each visit, patients rated their pain on an 11-point scale (0 = none to 10 = pain as bad as it could be) immediately after injection and 15—30 minutes after injection and provided their impressions of and preferences for each delivery system. Safety events were recorded throughout the study and 70 days after final study dose. Fifty-two patients were enrolled in the trial and completed all 3 visits (32 women, 20 men; mean [SD] age, 53.8 [12.1] years). Forty (76.9%) patients reported that the Pen was less painful than the syringe, 4 (7.7%) patients found the syringe to be less painful, and 8 (15.4%) patients had no preference. Patients had statistically significant reductions in injection-pain scores from visit 1 to visit 2 and from visit 1 to visit 3. No new safety signals or apparent differences regarding tolerability between the syringe and Pen were observed. In addition, 46 (88.5%) patients preferred the Pen, 3 (5.8%) preferred the syringe, and 3 (5.8%) had no preference. Overall, patients evaluated the Pen as easier to use (94.2%), more convenient (92.3%), requiring less time to inject (82.7%), and safer (88.5%). Patients experienced less pain self-administering adalimumab via the Pen and preferred it versus the syringe. Further, patients perceived the Pen to be easier to use and more convenient. Both delivery systems were generally well tolerated.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	0149-2918 1879-114X
DOI:	10.1016/j.clinthera.2006.10.006