The purpose of the study was to investigate the effectiveness and tolerability of transdermal fentanyl in a treatment regimen in patients with rheumatoid arthritis (RA).
Two hundred twenty-six patients (mean age 66 y) with severe pain caused by RA who had not previously been treated with transdermal fentanyl were included in this prospective, open-label study. Pain intensity, functional impairment, and well-being were documented prospectively for 30 days after treatment with transdermal fentanyl had been initiated. Patients evaluated pain on an 11-point numerical rating scale. Quality of sleep, daily and social functioning, and treatment satisfaction were rated using 5-point categorical rating scales. General well-being was assessed by the Marburg questionnaire.
Adding transdermal fentanyl to the ongoing RA therapy reduced pain intensity significantly from 8.0 (7.82 to 8.18) to 4.0 (3.75 to 4.25). Mean functional impairment due to pain also decreased significantly from “severe” at the beginning to “mild to moderate.” Treatment with transdermal fentanyl also led to a significant improvement by approximately 1.5 units for all items in the Marburg questionnaire on general well-being. At the end of the study, nearly all patients were satisfied with the pain treatment. Transdermal fentanyl was generally well tolerated. The most frequent side effects were nausea (9.7%) and vomiting (7.1%).
Patients with pain caused by RA improved in terms of pain intensity, sleep, function, and general well-being when transdermal fentanyl was added to the treatment regimen. Treatment satisfaction was high. Transdermal fentanyl also demonstrated good tolerability over a period of 30 days.
*Department of Physical Medicine and Rehabilitation, HELIOS Klinikum Berlin-Buch, Teaching Hospital of the Humboldt University Berlin, Hobrechtsfelder Chaussee 100, 13125 Berlin
†Janssen-Cilag GmbH, Raiffeisenstrasse 8, D-41470 Neuss, Germany
Supported by Janssen-Cilag GmbH, Germany.
Reprints: Prof Michael N. Berliner, MD, PhD, Department of Physical Medicine and Rehabilitation, HELIOS Klinikum Berlin-Buch, Hobrechtsfelder Chaussee 100, 13125 Berlin, Germany (e-mail: Mberliner@berlin.helios-kliniken.de).
Received for publication September 26, 2006; accepted April 16, 2007