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Adalimumab for long-term treatment of psoriatic arthritis: two-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT)
  1. P J Mease (pmease{at}nwlink.com)
  1. Rheumatology, United States
    1. P Ory (peter.ory{at}comcast.net)
    1. University of Washington, United States
      1. J T Sharp (johntsharp{at}comcast.net)
      1. University of Washington, United States
        1. C T Ritchlin (christopher_ritchlin{at}urmc.rochester.edu)
        1. University of Rochester Medical Center, United States
          1. F van den Bosch (filip.vandenbosch{at}ugent.be)
          1. UZ Gent, Belgium
            1. F Wellborne (fwellborne{at}hotmail.com)
            1. Houston Institute for Clinical Research, United States
              1. C Birbara (cabirbara{at}aol.com)
              1. University of Massachusetts Medical School, United States
                1. G TD Thomson (gthomson{at}ciads.ca)
                1. CIADS Research, Canada
                  1. R J Perdok (renee.perdok{at}abbott.com)
                  1. Abbott, United States
                    1. J Medich (john.medich{at}abbott.com)
                    1. Abbott, United States
                      1. R L Wong (robert.wong{at}abbott.com)
                      1. Abbott, United States
                        1. D D Gladman (dafna.gladman{at}utoronto.ca)
                        1. Centre for Prognosis Studies, Burkina Faso

                          Abstract

                          Objective: To evaluate the long-term effectiveness and tolerability of adalimumab in the treatment of psoriatic arthritis (PsA).

                          Methods: Patients with PsA who completed a 24-week, double-blind study of adalimumab versus placebo were eligible to enroll in an open-label extension study and receive adalimumab 40 mg subcutaneously every other week for up to an additional 120 weeks. At the time of this analysis, available efficacy evaluations through 2 years of treatment (n=245) included American College of Rheumatology (ACR) 20%, 50%, and 70% improvement scores, measures of joint disease and skin disease, disability, and quality of life; modified total Sharp score (mTSS) were available through 2.75 years of treatment for patients who received adalimumab in the 24-week study.

                          Results: After 24 weeks of double-blind treatment, the mean change in mTSS was –0.2 for the adalimumab group (N = 144) and 1.0 for the placebo group (N = 152) (p<0.001), and outcomes for all individual ACR component variables were significantly improved in adalimumab- compared with placebo-treated patients. Compared with 24-week responses, inhibition of radiographic progression and improvements in joint disease were maintained in most patients during long-term, open-label adalimumab treatment. Also, improvements in skin disease were maintained, with >20% of patients achieving the strict criterion of Psoriasis Area and Severity Index (PASI) 100. The nature and frequency of adverse events during long-term adalimumab treatment were consistent with the safety profile during short-term treatment.

                          Conclusions: The clinical and radiographic efficacy of adalimumab demonstrated during short-term treatment was sustained during long-term treatment. Adalimumab has a favorable risk–benefit profile in patients with PsA.

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