Counseling Points - December 2008 - (Page 5)

has the addition of polyethylene glycol, a substance that increases the drug’s plasma half-life and allows for less frequent dosing than some of the other TNF inhibitors currently available. Certolizumab selectively targets TNF in inflamed tissue and is dosed as either once every 2 weeks or once every 4 weeks via subcutaneous administration.1,2,6 Results from a recently completed phase-3, randomized, double-blind, placebo-controlled, parallel-group study demonstrated that certolizumab plus methotrexate significantly reduced signs and symptoms of RA as compared with placebo plus methotrexate.6 This study, known as the RA Prevention of Structural Damage 1 (RAPID 1) trial, randomized 982 patients to receive either 400 mg of subcutaneous certolizumab given at 0, 2, and 4 weeks with a subsequent dosage of 200 mg or 400 mg administered every 2 weeks, plus methotrexate, or placebo plus methotrexate.6 Response rates were assessed by using the American College of Rheumatology (ACR) 20 criteria (see box), whereby a patient must demonstrate a ≥20% improvement in the number of swollen and tender joints plus improvement in three of five additional measures. At 24 weeks, patients in the certolizumab 200 mg and 400 mg plus methotrexate groups demonstrated ACR20 response rates of 58.8% and 60.8%, respectively, compared with 13.6% of placebo plus methotrexate patients.6 Additionally, investigators noted that certolizumab had a rapid onset of action that was apparent after the first injection. During the first week of the study, significantly more patients in both certolizumab cohorts achieved ACR20 responses compared with patients in the placebo group (22.9% and 22.3% versus 5.6%, respectively).6 Patients treated with certolizumab also experienced significant improvements in swollen and tender joint counts and all other components of the ACR core set disease activity measures. Furthermore, results of subjects’ radiographic assessments established that individuals assigned to certolizumab had significantly less structural damage than placebo patients.6 The most common side effects of certolizumab are similar to other anti-TNF therapies currently on the market and include infections (sometimes serious) such as tuberculosis, upper respiratory infections, and urinary tract infections, and noninfectious adverse events, such as headache, hypertension, and nausea. Instances of lymphoma, multiple sclerosis (MS), heart failure, and lupuslike syndromes have been reported with TNF inhibitors, but are rare.1,6 5 ACR 20/50/70 Response Rates The ACR has developed its own scoring system known as the ACR 20/50/70 to assess disease improvement. This evaluation includes seven measures: swollen joint count, tender joint count, patient global assessment, erythrocyte sedimentation rate or C-reactive protein level, physical function, pain, and physician global assessment. To score an ACR 20, the patient must demonstrate a 20% improvement in the number of swollen and tender joints plus improvement in three of five of the additional measures. An ACR 50 or ACR 70 demonstrates a 50% or 70% improvement, respectively, in the joint count plus improvement in three of the five additional measures. Sources: American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis 2002 update. Arthritis Rheum. 2002;46:328-346; and Saag KG, Teng GG, Patkar N, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59:762–784. Golimumab The human monoclonal antibody golimumab is currently being evaluated for both subcutaneous and intravenous (IV) administration to treat RA.1,3-4 This agent is also being studied as a potential treatment for ankylosing spondylitis, ulcerative colitis, and psoriatic arthritis.1 The pharmacokinetic profile of golimumab, similar to other TNF agents, targets and neutralizes both the soluble and membranebound forms of TNF.1,2 Due to an 8-fold binding capacity, it offers a less frequent dosing regimen than the currently marketed TNF inhibitors adalimumab and etanercept. In RA, golimumab is being investigated as a once-monthly subcutaneous injection or as an every-3-month infusion.1,2 Golimumab in combination with methotrexate was noted to be efficacious in a number of clinical trials, including the recently completed Golimumab for Subjects With Active RA Despite Methotrexate (GO-FORWARD) trial.7 This double-blind, phase-3 investigation evaluated 172 RA patients who previously had had an inadequate response to methotrexate. 7 Subjects were randomly assigned to receive placebo injections plus methotrexate or golimumab 50 mg or 100 mg every 2 or 4 weeks plus methotrexate. Results from the study demonstrated that DECEMBER 2008

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Counseling Points - December 2008

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