title: 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.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  The aim of this study was to assess injection-site pain, tolerability, and patient preference of 2 delivery systems of adalimumab.
  
  
  METHODS
  Patients with rheumatoid arthritis were enrolled in a Phase II, multicenter, open-label, single-arm, 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.
  
  
  RESULTS
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, USA. akivitz@prodigy.net
authors.forename: Alan
authors.initials: A
authors.lastname: Kivitz
authors.forename: Steven
authors.initials: S
authors.lastname: Cohen
authors.forename: James Edward
authors.initials: JE
authors.lastname: Dowd
authors.forename: William
authors.initials: W
authors.lastname: Edwards
authors.forename: Suman
authors.initials: S
authors.lastname: Thakker
authors.forename: Frank R
authors.initials: FR
authors.lastname: Wellborne
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Renz
authors.forename: Oscar G
authors.initials: OG
authors.lastname: Segurado
mesh_terms: D000068879:Adalimumab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D010146:Pain / Q000209:etiology*; D010349:Patient Compliance; D012646:Self Administration; D013594:Syringes
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D000068879:Adalimumab