Rheumatoid Arthritis: Richarz U

Le Loët X, Pavelka K, Richarz U. · Centre Hospitalier Universitaire de Rouen, Hôpitaux Rouen, Rouen, France. · BMC Musculoskelet Disord. · Pubmed #15958159 links to  free full text

Abstract: BACKGROUND: This study was designed to evaluate the utility of transdermal fentanyl (TDF, Durogesic) for the treatment of pain due to osteoarthritis (OA) of the knee or hip, which was not adequately controlled by non-opioid analgesics or weak opioids. The second part of the trial, investigating TDF in patients with rheumatoid arthritis (RA) is reported separately. METHODS: Current analgesia was optimised during a 1-week run-in. Patients then received 28 days treatment with TDF starting at 25 microg/hr, with the option to increase the dose until adequate pain control was achieved. Metoclopramide was taken during the first week and then as needed. RESULTS: Of the 159 patients recruited, 75 with OA knee and 44 with OA hip completed the treatment phase, 30 knee and 18 hip patients entered the one-week taper-off phase. The most frequently used maximum dose of TDF was 25 microg/hr. The number of patients with adequate pain control increased during the run-in period from 4% to 27%, and further increased during TDF treatment to 88% on day 28. From baseline to endpoint, there were significant reductions in pain (p < 0.001) and improvements in functioning (p < 0.001) and physical (p < 0.001) and mental (p < 0.05) health. Scores for 'pain right now' decreased significantly within 24 hours of starting TDF treatment. TDF was assessed favourably and 84% of patients would recommend it for OA-related pain. Nausea and vomiting were the most common adverse events (reported by 32% and 26% of patients respectively), despite prophylaxis with metoclopramide, which showed limited efficacy in this setting. CONCLUSION: TDF significantly increased pain control, and improved functioning and quality of life. Metoclopramide appeared to be of limited value in preventing nausea and vomiting; more effective anti-emetic treatment may enable more people to benefit from strong opioids such as TDF. This study suggests that four weeks is a reasonable period to test the benefit of adding TDF to improve pain control in OA patients and that discontinuing therapy in cases of limited benefit creates no major obstacles.

Pavelka K, Le Loet X, Bjorneboe O, Herrero-Beaumont G, Richarz U. · Institute of Rheumatology, Prague, Czech Republic. · Curr Med Res Opin. · Pubmed #15701214 No free full text.

Abstract: OBJECTIVES: To evaluate the effectiveness and safety of transdermal fentanyl (TDF) for the treatment of pain associated with rheumatoid arthritis (RA) or osteoarthritis of the knee or hip (OA), which was not adequately controlled by non-opioid analgesics and/or weak opioids. METHODS: The study design incorporated a 1-week run-in period when current analgesic medications were optimised, a 28-day treatment period and a 1-week taper-off period. Patients with RA (n = 104) and OA (n = 159) started treatment with TDF 25 microg/h. Patches were replaced every 72 h, with the option to up-titrate until adequate pain control was achieved. Metoclopramide was taken during the first treatment week and as needed thereafter. RESULTS: 203 patients completed the treatment phase, 90 entered the taper-off phase. 25 microg/h was the most frequently used maximum dose (51%). Pain control was increased from 4% to 29% of patients during run-in. The number of patients reaching adequate pain control in the first treatment week was increased to 75%, and increased further to 88% on day 28 and to 80% at endpoint. From baseline (screening) to endpoint, there were significant reductions in pain (p < 0.001) on the Wisconsin Brief Pain Inventory, and significant improvements in quality of life (Short-Form-36: physical p < 0.001; mental health p < 0.05). Eighty per cent of the patients (n = 134) assessed the treatment favourably; nausea and vomiting were the most common adverse events, mainly occurring at treatment initiation. Efficacy of metoclopramide appeared limited. TDF could be initiated in patients pre-treated with non-opioid analgesics or weak opioids and tapered off without major complications. CONCLUSIONS: TDF significantly improved pain control and quality of life, and was well tolerated in patients with RA or knee/hip OA who continued to experience pain on their current analgesic treatment. Treatment could be discontinued without issues. Nausea and vomiting was usually mild during treatment initiation. Patients' well being could be further accommodated by optimising prophylactic treatment.

Herrero-Beaumont G, Bjorneboe O, Richarz U. · Fundacion Jimenez Diaz, Avenida de los Reyes Catolicos 2, 28040 Madrid, Spain. · Rheumatol Int. · Pubmed #15480678 No free full text.

Abstract: This study evaluated transdermal fentanyl (TDF) for the treatment of pain from rheumatoid arthritis (RA) which was not adequately controlled by nonopioid analgesics and/or weak opioids. Following 1 week of optimization of current analgesic medication, patients (n = 104) started 28-day treatment with 25 microg/h of TDF, with the option to up-titrate until adequate pain control was achieved. Metoclopramide was taken during the 1st week and as needed thereafter. Eighty-four patients completed the treatment phase, and 42 entered the 1-week tapering-off phase. The most frequently used maximum dose was 25 microg/h. The number of patients with pain control increased, particularly in the 1st week of treatment (33% to 77%), to 88% on day 28. From baseline to endpoint, there were reductions in pain (P < 0.001), including in "pain right now" at 24 h, and in degree of pain (mean reduction from "severe" to "moderate"), improvements in function (majority of items in the Health Assessment Questionnaire) (P < 0.001), and in quality of life (Short Form 36 physical P < 0.001, mental P < 0.05). Treatment was assessed favorably: > or = 78% would recommend it. Transdermal fentanyl should be considered in treatment programs for patients with RA.