Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Patient Global Impression of Change Results from a 1-Year Open-Label Extension Study of Tapentadol Extended Release in Patients with Chronic Osteoarthritis or Low Back Pain.

McCann2,  Bettyanne, Lange1,  Robert, Wagner2,  Bertil, Steup1,  Achim, Lange1,  Bernd, Etrolpolski2,  Mila

Global Development, Grünenthal GmbH, Aachen, Germany
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ

Background:

Tapentadol is a centrally acting analgesic with 2 mechanisms of action, m-opioid receptor agonism and norepinephrine reuptake inhibition. The safety and tolerability of tapentadol extended release (ER) were assessed in a 1-year open-label extension study (ClinicalTrials.gov Identifier: NCT00487435); efficacy was evaluated using the patient global impression of change (PGIC).

Methods:

Patients were eligible for enrollment in this study if they completed 1 of 4 phase 3 studies: two 15-week studies that evaluated the efficacy of tapentadol ER and oxycodone controlled release (CR) compared with placebo for chronic osteoarthritis knee pain (NCT00421928) or low back pain (NCT00449176), a crossover study (two 2-week periods following a 3-week titration with tapentadol immediate release) to assess dose conversion between the immediate-release and extended-release formulations of tapentadol in patients with chronic low back pain (NCT00594516), or a 1-year controlled long-term safety study of tapentadol ER and oxycodone CR in patients with chronic osteoarthritis hip or knee pain or low back pain (NCT00361504). Patients who completed 1 of the efficacy studies or the crossover study or who received oxycodone CR in the 1-year safety study were titrated to their optimal therapeutic dose of tapentadol ER (100–250 mg bid) during a titration period of up to 4 weeks; patients then continued on that optimal dose during a maintenance period of up to 48 weeks. Patients who received tapentadol ER during the 1-year safety study continued on their optimal dose determined in the parent study. Dose adjustments within the therapeutic range were permitted under the supervision of a physician throughout the current study. The PGIC, which was completed at baseline of this trial, at Weeks 24 and 48 of maintenance, and at the end of treatment, was used to assess patient's subjective changes in their overall status from baseline to endpoint. Patients indicated their perceived change by completing the statement "Since I began study treatment, my overall status is:" using a 7-point scale (1 ="very much improved," 2 ="much improved," 3 ="minimally improved," 4 ="no change," 5 ="minimally worse," 6 ="much worse," 7 ="very much worse"). Adverse events (AEs) were monitored throughout the study.

Results:

The safety population included 1,154 patients, the intent-to-treat population included 1,149 patients, and PGIC data at endpoint were available for 1,059 patients. The majority (61.4%[650/1,059]) of patients reported a change in overall status at endpoint of "very much improved" or "much improved," and an additional 25.7% (272/1,059) of patients reported that their overall status was "minimally improved." The most commonly reported (>10%) TEAEs included headache (13.1%[151/1,154]), nausea (11.8%[136/1,154]), and constipation (11.1%[128/1,154]).

Conclusion:

Long-term treatment with tapentadol ER (100–250 mg bid) for up to 1 year (and up to 2 years for some patients) was associated with an improvement in overall status for the majority of patients in this open-label extension study of patients with moderate to severe chronic osteoarthritis pain or low back pain.

To cite this abstract, please use the following information:
McCann, Bettyanne, Lange, Robert, Wagner, Bertil, Steup, Achim, Lange, Bernd, Etrolpolski, Mila; Patient Global Impression of Change Results from a 1-Year Open-Label Extension Study of Tapentadol Extended Release in Patients with Chronic Osteoarthritis or Low Back Pain. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :950
DOI: 10.1002/art.28717

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