Subcutaneously administered methotrexate for rheumatoid arthritis, by prefilled syringes versus prefilled pens: patient preference and comparison of the self-injection experience

Winfried Demary, Holger Schwenke, Karin Rockwitz, Peter Kästner, Anke Liebhaber, Ulrich Schoo, Georg Hübner, Uwe Pichlmeier, Cécile Guimbal-Schmolck, Ulf Müller-Ladner, Winfried Demary, Holger Schwenke, Karin Rockwitz, Peter Kästner, Anke Liebhaber, Ulrich Schoo, Georg Hübner, Uwe Pichlmeier, Cécile Guimbal-Schmolck, Ulf Müller-Ladner

Abstract

Purpose: This multicenter, randomized, crossover study compared preference, ease of use, acceptability, satisfaction, and safety of repeated subcutaneous (SC) self-administrations with prefilled pens and prefilled syringes delivering methotrexate (MTX), in patients with rheumatoid arthritis (RA).

Patients and methods: The study (ClinicalTrials.gov number NCT01793259) enrolled 120 patients requiring initiation or intensification of MTX therapy for RA. Patients were randomized to receive the test drug, a prefilled pen (Metex(®) PEN/Metoject(®) PEN), or the reference drug, a prefilled syringe (Metex(®)/Metoject(®)), at doses of 15, 17.5, or 20 mg MTX SC once a week for 3 weeks. This was followed by receipt of the reference drug (prefilled syringe) or the test drug (prefilled pen) in a crossover design, with each patient serving as his/her own control. Questionnaires regarding patient preference, the Self-Injection Assessment Questionnaire (SIAQ), and diaries regarding local tolerability were used to document outcomes.

Results: Overall patient preference for the MTX prefilled pen was 75% (P<0.0001). In a six-item questionnaire, 73% to 76% of the patients preferred the prefilled pen in relation to use, acceptability, and satisfaction, and 67% of the patients confirmed that it did not take much effort to overcome SC self-injection with the pen. The SIAQ showed no clinical differences, in any domain scores, between both devices. Overall patient attitude towards self-injection at baseline was positive, as was patient experience with both devices during the study. As well, 92% of physicians and study nurses indicated that they would recommend the MTX prefilled pen to patients for future MTX treatment. The formulations were generally well tolerated.

Conclusion: SC self-injection of MTX with a prefilled pen was generally preferred, by patients with RA, over a prefilled syringe with regard to use, acceptability, and satisfaction. This is supported by the strong appreciation of their attending study nurses and physicians, for its convenience.

Keywords: injection device; methotrexate.

Figures

Figure 1
Figure 1
Overall preference for MTX prefilled pen and stratification by baseline characteristics. Notes: N = total number of patients, excluding three patients with missing information (n=2) and concomitant use of pen and syringe (n=1) (complete-case analysis); n= number of patients with preference for pen. Abbreviations: BMI, body mass index; CI, confidence interval; DAS28, Disease Activity Score 28; MTX, methotrexate.
Figure 2
Figure 2
Distribution of domain scores of the SIAQ POST-module (histogram for each device; LS means among figures are connected). Abbreviations: CI, confidence interval; diff, difference; LS, least square; SIAQ, Self-Injection Assessment Questionnaire.

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Source: PubMed

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