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

Winfried Demary,1 Holger Schwenke,2 Karin Rockwitz,3 Peter Kästner,4 Anke Liebhaber,5 Ulrich Schoo,6 Georg Hübner,7 Uwe Pichlmeier,8 Cécile Guimbal-Schmolck,8 Ulf Müller-Ladner9 1Private practice, Hildesheim, Germany; 2Private practice, Dresden, Germany; 3Private practice, Goslar, Germany; 4Outpatient Rheumatism Center, Erfurt, Germany; 5Private practice, Halle, Germany; 6Private practice, Rheine, Germany; 7Private practice, Lingen, Germany; 8medac GmbH, Hamburg, Germany; 9Department of Rheumatology and Clinical Immunology, Kerckhoff-Klinik GmbH, Bad Nauheim, Germany 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: methotrexate, injection devic