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

Abstract:Background/objectives: This postmarketing surveillance study assessed the preference, satisfaction, usability, and tolerability of subcutaneous self-administration of a highconcentration (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 selfadministered 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.

The comparative effectiveness of oral versus subcutaneous methotrexate for the treatment of early rheumatoid arthritis

“…There is also little evidence to suggest that patients prefer oral over parenteral MTX. Parenteral formulations have been shown to have high tolerability 26. Cost may also be an issue, although generic subcutaneous MTX, available in many countries, is roughly 10% the cost of biological therapy;27 optimising the use of traditional DMARDs may have cost savings.…”

Condicionantes demográficos y clínicos para la elección inicial de la vía de administración de metotrexato y motivos para un posterior cambio de vía (Estudio MOTICAR)

“…Hay que reseñar que nuestro estudio no evaluaba el cumplimiento del tratamiento en la población estudiada, pero diversos autores proponen el cambio a la forma inyectable para pacientes con bajo cumplimiento y/o efectos gastrointestinales del metotrexato oral [11,14,15,[23][24][25][26][27][28]. Estos trabajos ponen de relieve una mayor probabilidad de eficacia con metotrexato inyectable y un mejor perfil de efectos adversos gastrointestinales que con metotrexato oral.…”

Methotrexate: New Therapeutic Approaches

“…50 Considering that the usefulness of test doses of MTX in psoriasis is still being questioned (treatment is commonly initiated with a dose of 10 to 15 mg in selected patients), 51 the advantages of subcutaneous MTX in rheumatoid arthritis (greater efficacy 45 and fewer gastrointestinal problems 52 ) could probably be extrapolated to psoriasis, and it would appear reasonable to assume that subcutaneous MTX will be increasingly used in dermatology. Greater familiarity with subcutaneous injections among dermatology patients will undoubtedly contribute to this increased use, as will the introduction of higher-concentration formulations (50 mg/mL) in prefilled syringes, as these offer greater tolerability and convenience 53 and are preferred to the 10-mg/mL formulations by the majority of patients treated with 20 mg per week. 54 Single-dose formulations also have environmental and safety benefits as they eliminate the need to handle and discard unused portions of vials or syringes.…”