Tolerability and Patient/Physician Satisfaction with Subcutaneously Administered Methotrexate Provided in Two Formulations of Different Drug Concentrations in Patients with Rheumatoid Arthritis



Ulf Müller-Ladner*, 1, Karin Rockwitz2, Jan Brandt-Jürgens3, Roland Haux3, Peter Kästner4, Jürgen Braun5, Winfried Demary6, Cécile Guimbal-Schmolck7, Uwe Pichlmeier7, Andreas Brandt7, for the MC-MTX.10/RH Study Group
1 Kerckhoff-Klinik, Bad Nauheim, Germany
2 Practising Rheumatologist, Goslar, Germany
3 Practising Rheumatologist, Berlin, Germany
4 Practising Rheumatologist, Erfurt, Germany
5 Rheumazentrum Ruhrgebiet, Herne, Germany
6 Practising Rheumatologist, Hildesheim, Germany
7 Medac Gesellschaft für klinische Spezialpräparate mbH, Hamburg, Germany


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© Müller-Ladner et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the Kerckhoff-Klinik GmbH, Department of Rheumatology and Clinical Immunology, Benekestrasse 2-8, D-61231 Bad Nauheim, Germany; Tel: + 49-6032-9962101; Fax: + 49- 6032-9962104; E-mail: u.mueller-ladner@kerckhoff-klinik.de


Abstract

Objectives:

To determine preference, satisfaction, usability and local tolerability by patients, physicians and study nurses of two subcutaneously administered methotrexate (MTX) formulations of different concentrations.

Methods:

This was an open-label, comparative, within-patient controlled, multicentre study of 132 patients with rheumatoid arthritis (RA). MTX treatment consisted of 20 mg/week administered as a medium-concentration formulation (MC) (2.0 ml of 10 mg/ml solution in prefilled syringe; separate needle) compared to a novel high-concentration formulation (HC) (0.4 ml of 50 mg/ml in prefilled syringe; pre-attached needle). Each treatment was given for three weeks. Questionnaires and visual analogue scales were used to measure outcomes.

Results:

At the end of the study, 93% of the patients preferred HC over MC as further treatment. Overall assessment of HC was “good” or “very good” in 90.6% vs 34.4% in MC-treated patients. Physician’s and patients global assessment of syringe usability showed highly statistically significant differences (P < 0.0001) in favour of HC. Overall assessment by study nurses’ and investigators’ was “good” (18.8%) or “very good” (81.2%) for HC and “good” in 31.3% or “very good” in 12.5% for MC, and no preference in 50%. Local tolerability improved slightly also with HC.

Conclusions:

The total smaller volume of administered drug and the improved usability of a pre-attached needle in combination with a smaller prefilled syringe resulted in preference of the patients of HC over MC. The slightly improved local tolerability may also have added to this preference. This assessment was confirmed by similar assessments made by healthcare professionals.

Eudra-CT number: 2007-003591-19.

Keywords: Methotrexate, subcutaneous injection, prefilled syringe, rheumatoid arthritis..