Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
3-Year Efficacy of Milnacipran in Patients with Fibromyalgia: An Open-Label, Flexible-Dosing Study.
Arnold1, Lesley M., Ma2, Yimin, Palmer2, Robert H., Spera2, Allan, Baldecchi2, Arlene
Milnacipran is approved for the management of fibromyalgia (FM), a chronic disorder characterized by widespread pain and other symptoms that adversely impact function and health-related quality of life. Because FM is a chronic disorder, long-term efficacy is an important treatment goal. Previous studies have demonstrated the efficacy of milnacipran in managing FM symptoms for up to 1 year. This study extends those findings by evaluating the long-term efficacy of milnacipran for a period of up to 3.25 years.
In this open-label study, the treatment effects of milnacipran were evaluated in patients with FM (N=1227) over a period of up to 3.25 years (or until the study was terminated administratively). Patients successfully completing previous milnacipran studies were eligible for enrollment. This study comprised a 2-week washout period, a 2-week dose-escalation period (to milnacipran 100 mg/day), an 8-week dose-stabilization period (at milnacipran 100 mg/day), and a flexible-dose period (milnacipran 50200 mg/day) for the remainder of the study. Key efficacy outcomes included mean changes from study baseline (after 2 week washout) in weekly recall VAS pain (0100 mm scale), Patient Global Impression of Change (PGIC), Patient Global Disease Status (PGDS), SF-36 Physical Component Summary (PCS), and the Brief Pain Inventory (BPI). Efficacy analyses were reported for the intent-to-treat (ITT) population at the end of study (ie, last available assessment). Additional cohort analyses for weekly recall VAS pain were performed in order to assess the long-term effects of treatment in defined groups of patients treated for varying periods of time.
For the ITT population, milnacipran-treated patients showed an improvement in pain, with a mean decrease from baseline in weekly recall VAS pain score of 17.6 mm. Additionally, improvements in BPI scores, global status (PGIC, PGDS), and physical function (SF-36 PCS) were all observed with milnacipran treatment for the ITT population. Because the number of patients with available data in the ITT population varied at each visit, we used weekly recall VAS pain to assess improvements over time in specified cohorts. In the cohort of patients completing >=3 years (n=217), the observed pain improvement was reached by Month 3 and remained relatively constant throughout the entire study; weekly recall pain VAS scores improved by 23.9 mm in these patients at the final study visit (Month 3638). Similar improvements from baseline in weekly recall VAS pain were observed over time and remained constant in the 2-year cohort (n=461) and the 1-year cohort (n=820).
The findings from this open-label study provide support for sustained long-term efficacy (in some cases exceeding 3 years of continuous treatment) of milnacipran in improving pain, global status, and physical functioning in patients with FM.
To cite this abstract, please use the following information:
Arnold, Lesley M., Ma, Yimin, Palmer, Robert H., Spera, Allan, Baldecchi, Arlene; 3-Year Efficacy of Milnacipran in Patients with Fibromyalgia: An Open-Label, Flexible-Dosing Study. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :1907