Preference, satisfaction and usability of subcutaneously administered methotrexate for rheumatoid arthritis or psoriatic arthritis: results of a postmarketing surveillance study with a high-concentration formulation

Abstract

Background/objectives: This postmarketing surveillance study assessed the preference, satisfaction, usability, and tolerability of subcutaneous self-administration of a high-concentration (50 mg/ml) ready-to-use formulation of methotrexate (MTX) in patients with rheumatoid arthritis or psoriatic arthritis.

Methods: The study enrolled 403 patients with rheumatoid or psoriatic arthritis. The first injection was administered by the attending physician or nurse, followed by five self-administered injections at weekly intervals. The high-concentration formulation consisted of a prefilled syringe with MTX 50 mg/ml solution and a pre-attached needle. Questionnaires were used to document outcomes.

Results: The overall assessment was 'very good' and 'good' in 87.6% of the patients and in 92.8% of the physicians/study nurses. Availability and use of a pre-attached needle was considered as very advantageous and advantageous by 91.8% of the patients and 88.8% of the physicians/study nurses. A total of 96% of the patients described the feeling of the injection as comfortable or tolerable. Patients reported that self-administration led to a feeling of more independence (89.1%) and an improved quality of life (83.6%). A total of 109 patients reported previous self-administration of low-concentration MTX formulations; 94.5% of them stated that they would prefer the high-concentration MTX formulation in the future. The formulation was generally well tolerated. Physicians' expectations concerning the benefit of switching to MTX self-administration was met in 92.8% of the patients. A total of 96.3% of the patients were considered suitable for subcutaneous self-administration of the MTX formulation.

Conclusions: The 50 mg/ml prefilled syringe appears to be a valuable treatment option for patients with rheumatoid and psoriatic arthritis in need of MTX. This is supported by the strong appreciation of the patients as well as their attending healthcare professionals for its convenience and tolerability. The results confirm the findings and experience from a clinical study performed in Germany in 2009, which showed that 93% of the patients prefer the 50 mg/ml prefilled syringe with a pre-attached needle.

Keywords: methotrexate; parenteral; postmarketing surveillance study; pre-attached needle; prefilled syringe; psoriatic arthritis; rheumatoid arthritis; self-administration; subcutaneous injection.

Conflict of interest statement

FS has no conflicts of interest to declare. AB is an employee of medac GmbH.

Figures

Figure 1.

Overall assessment of MTX prefilled syringe 50 mg/ml (n = 403).

Figure 2.

Overall assessment of pre-attached needle in patients with previous experience of low-concentration MTX 10 mg/ml (n = 109).

Figure 3.

Different volumes of a 20 mg dose comparing the concentrations 10 mg/ml (2 ml to inject), 20 mg/ml (1 ml to inject) or 50 mg/ml (0.4 ml to inject).