New research presented at the AAD's 65th Annual Meeting regarding treatment of biologic psoriasis with adalimumab and efalizumab.
A more effective biologic agent is on the horizon for treating moderate-to-severe plaque psoriasis, and an already-approved biologic has demonstrated significant improvements in challenging cases of hand and foot psoriasis, according to trial results presented during the American Academy of Dermatology's 65th Annual Meeting in Washington, DC, February 2–6, 2007.
"The phase 3 results are very impressive, with a PASI 75% clearing achieved by 71% of patients," said Robert E. Kalb, MD, State University of New York School of Medicine, Buffalo. "The cost is the same as etanercept with a PASI 75 response in 30% to 40%, so you have double the efficacy for the same cost." Subcutaneous adalimumab also offers a treatment advantage over infliximab, which requires intravenous infusion, he said.
Patients achieving a PASI ≥75 response after 16 weeks entered an open-label, sustained-response treatment period for 17 weeks and received adalimumab 40 mg every other week. Those having a PASI <75 response entered an open-label extension study through Week 52.
After 33 weeks, patients achieving a PASI ≥75 were rerandomized to continued adalimumab treatment or placebo for an additional 19 weeks. Patients achieving a PASI 50 to 75 at 33 weeks entered the open-label extension, and those achieving a PASI <50 discontinued the study.
The primary end points were the percentage of patients achieving a PASI 75 improvement after 16 weeks and the percentage of patients losing adequate treatment response at Week 52 after discontinuing adalimumab at Week 33. Loss of adequate treatment response was defined as a PASI ≤50 or an increase of ≥6 PASI points.
The mean baseline PASI score for the initial treatment period was 18.9. After 16 weeks, 71% of patients receiving adalimumab achieved a PASI ≥75 compared with 6.5% of patients receiving placebo (P=.001). In addition, 20% of patients receiving treatment versus 0.8% of patients taking placebo achieved a PASI 100 response (P=.001). A total of 590 patients receiving adalimumab and 26 patients receiving placebo entered the open-label treatment period. At Week 33, there was a mean PASI 89 improvement among patients continuously treated with adalimumab.
During the third treatment period, 240 patients were randomized to placebo and 250 continued adalimumab. At Week 52, 28.4% of patients receiving placebo lost an adequate treatment response compared with 4.9% of patients receiving adalimumab (P=.001).
"An important goal of psoriasis treatment is to not only clear the skin initially, but to help patients maintain clearance over time," said Alan Menter, MD, chairman, Division of Dermatology, Baylor University, Dallas, Tex. "In this study, the majority of patients receiving adalimumab achieved both of those goals."
The most common adverse events among patients receiving adalimumab were respiratory tract infections, naso-pharyngitis, sinusitis, and headache. One case of oral candidiasis occurred, and 1 presumptive diagnosis of tuberculosis was made in a patient who was PPD-positive at baseline. There were no cases of lymphoma, and rates of non-melanoma skin cancers and other malignancies were low and similar in both the placebo and adalimumab groups.
A phase 4, 12-week study of efalizumab in chronic, moderate-to-severe plaque psoriasis of the hands and feet included 80 patients randomized to subcutaneous efalizumab 1 mg/kg (n=52) once weekly or placebo (n=28). The primary end point was the percentage of patients attaining a Physician's Global Assessment (PGA) of clear, almost clear, or mild. At baseline, 75% of patients had a PGA rating of moderate and 25% had a PGA rating of severe.
After 12 weeks, 46.2% of patients receiving efalizumab achieved a PGA rating of clear, almost clear, or mild compared with 17.9% of patients receiving placebo (P=.015); 32.7% of patients receiving efalizumab and 7.1% of patients receiving placebo achieved a PGA of clear or almost clear (P=.013).
"Plaque psoriasis on the hands and feet has been historically difficult to treat and poses unique challenges to a patient's life, from the act of a handshake to the potentially crippling effect on a patient's ability to walk and wear shoes comfortably," said Craig Leonardi, MD, associate clinical professor of dermatology, St. Louis University Medical School, St. Louis, Mo.
"The results of this trial further validate a large number of published case reports where efalizumab treatment is effective in this often recalcitrant and hard-to-treat patient population," Dr Leonardi said.
Menter A, Papp KA, Leonardi CL, Gu Y, Rozzo SJ. Short- and long-term efficacy and safety of adalimumab in a pivotal phase III study in adult patients with moderate to severe chronic plaque psoriasis [abstract]. Paper presented at: American Academy of Dermatology 65th Annual Meeting; Washington, DC; February 2–6, 2007; Abstract P19.
Leonardi CL, Sofen H, Krell J, Caro I, Compton P, Sobell J. Phase IV study to evaluate the safety and efficacy of efalizumab for treatment of hand and foot plaque psoriasis [abstract]. Paper presented at: American Academy of Dermatology 65th Annual Meeting; Washington, DC; February 2–6, 2007; Abstract P532.