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

Abstract

PurposeThis 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 methodsThe 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.ResultsOverall 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.ConclusionSC 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.

Prefilled pen versus prefilled syringe: evaluation of methotrexate subcutaneous intake method in patients with juvenile idiopathic arthritis – results of the pilot study

“…In our study, we have assessed the preference for MTX pen as 82.6%. Despite the small size of the study population, the results are comparable to those obtained in patients with RA, where the preference for pen reached 75% [ 9 ]. Interestingly, despite our patients received the prefilled syringe treatment for a considerably longer period than the prefilled pen, their caregivers have evaluated the latter device as easier to use (p<0.01).…”

“…Nevertheless, pain and stress associated with subcutaneous injections are a significant drawback of this treatment, particularly prominent in younger patients.Subcutaneous MTX may be administered via two devices: the prefilled syringe or, recently introduced to the market, the pen autoinjector. The latter device was preferred by patients with rheumatoid arthritis (RA) with regards to overall satisfaction and ease of use [ 9 ]. The aim of this study was to assess the experience of patients with JIA and their caregivers who used both the prefilled syringes and the prefilled pens, concerning patients' preference, usability, and tolerability outcomes.…”

Using video‐based training for button‐free auto‐injection of subcutaneous methotrexate: A pilot study

“…Three studies have looked at the patient acceptability, usability and satisfaction of auto-injection devices for self-injection of MTX when compared with prefilled syringes (Demary et al, 2014;Hudry et al, 2017;Saraux et al, 2019). studies involving questionnaires, the possibility of self-selection bias is a limitation.…”

“…Over the last decade, a number of different devices have been developed for self-injection of SC MTX. Studies show that patients with rheumatoid arthritis prefer auto-injector devices to prefilled syringes, reporting them to be more convenient, easier to use and less painful (Demary et al, 2014;Pachon, Kivitz, Heuer, & Pichlmeier, 2014;Saraux, Hudry, Zinovieva, & SELF-I Investigators group, 2019;Thakur, Biberger, Handrich, & Farouk Rezk, 2016).…”

A Nationwide Survey on Patient’s versus Physician´s Evaluation of Biological Therapy in Rheumatoid Arthritis in Relation to Disease Activity and Route of Administration: The Be-Raise Study

“…In recent years the development of pre-filled syringes has promoted subcutaneous (SC) administration of biologicals and has therefore become an attractive alternative to an intravenous (IV) route of administration [3]. In this context, several studies have investigated the efficacy and safety of different biological therapies available in either IV or SC formula (eg.…”