Promising Amevive® (Alefacept) Phase Ii Psoriatic Arthritis Data Presented At American College Of Rheumatology Meeting
Impact on disease may be continued for almost one year with two 12-week administrations
SAN DIEGO (Nov. 15, 2005) - Findings from a recently completed Phase II study, presented at the annual meeting of the American College of Rheumatology (ACR), show that patients with active psoriatic arthritis who received AMEVIVE® (alefacept) achieved significant improvement in disease. Patients treated with AMEVIVE also experienced less progression of disease, as measured by radiographic assessment, than placebo-treated patients after 24 weeks.
“It is exciting that AMEVIVE, a non-anti-TNF biologic therapy, has demonstrated potential utility in the treatment of psoriatic arthritis in this difficult-to-treat patient population,” said Philip Mease, M.D., lead study investigator of Swedish Medical Center and University of Washington School of Medicine in Seattle. “These data for ACR score of disease activity demonstrate that a single course of AMEVIVE, in combination with methotrexate, produces a statistically significant impact on disease compared with methotrexate alone, and that response continued after a second 12-week course of treatment.”
In the study, patients received two treatment courses. In the double-blind, placebo-controlled first course, 185 patients with active psoriatic arthritis were randomized to receive either methotrexate and AMEVIVE or methotrexate and placebo. Patients in the AMEVIVE group (n=123) received 15 mg of AMEVIVE by intramuscular injection once a week for 12 weeks, followed by a 12-week observation period. Results were measured at week 24, 12 weeks after the last dose of the first course.
After the first course, an open-label, non-placebo-controlled second course was administered in which all patients (n=160) received AMEVIVE and methotrexate once a week for 12 weeks, followed by a 12-week observation period. Results were measured at week 48 of the study, 12 weeks after the last dose of the open-label second course.
New findings presented show that the progression of joint damage, evaluated after 24 weeks, was delayed in subjects receiving AMEVIVE and methotrexate in the placebo-controlled portion of the study (first course) compared with placebo and methotrexate. As measured radiographically with X-rays of hands and feet by the modified Sharp score, the mean change from baseline at six months was 0.3 in the treatment arm versus 1.3 in the placebo arm. At week 48 (open-label second course), results were inconclusive.
Results from the first course of therapy were announced on Feb. 18, 2005. At week 24, 54 percent of patients treated with AMEVIVE and methotrexate achieved an ACR 20 response, the study’s primary endpoint, in contrast to 23 percent in the methotrexate alone group. The response was measured using the ACR scale, a standard measure developed by the American College of Rheumatology to rate arthritis disease improvement. ACR 20, the study’s primary endpoint, ACR 50 and ACR 70 reflect a 20 percent, 50 percent and 70 percent improvement from baseline, respectively, in the signs and symptoms of psoriatic arthritis.
Response measured after an open-label second course of treatment suggested that the impact on disease may be continued for almost one year (48 weeks). Findings include the following:
* Patients who received an open-label second course of AMEVIVE and methotrexate achieved a similar ACR 20 response rate (55 percent at week 48) to that observed in the first course (54 percent at week 24).
* Of the patients who received placebo and methotrexate in the first course and went on to receive AMEVIVE and methotrexate in the open-label second course, 51 percent achieved an ACR 20 response.
* Of patients treated with an open-label second course of AMEVIVE and methotrexate, 32 percent achieved an ACR 50 response and 12 percent achieved ACR 70 at week 48. Similarly, 31 percent and 15 percent of patients achieved ACR 50 and 70, respectively, when they received one course of AMEVIVE and methotrexate, after receiving placebo and methotrexate in the first course.
All adverse events experienced by patients treated with alefacept in the study were mild or moderate, except for one case of arthritis and back pain in the first course. The most common adverse events in the first course were increased liver enzyme levels (6 percent), back pain (
6 percent) and viral upper-respiratory infections (5 percent). In the open-label second course of treatment, the most common adverse events were decreases in CD4+ lymphocytes (7 percent) and nasopharyngitis (5 percent). The incidence of serious adverse events (2 percent) for AMEVIVE in the first course was similar to placebo, and was similar after a second course of AMEVIVE. No malignancies were reported in patients treated with AMEVIVE.
“These initial results, if confirmed, suggest that AMEVIVE may offer relief to patients with both psoriasis and psoriatic arthritis,” said Mark Lebwohl, M.D., professor and chairman of the department of dermatology at The Mount Sinai School of Medicine in New York.
About Psoriatic Arthritis and Psoriasis
It is estimated that psoriatic arthritis afflicts up to 30 percent of people with psoriasis, causing stiffness, pain, swelling and reduced range of motion in the joints. An immune system disease, psoriatic arthritis can be as severe for some patients as rheumatoid arthritis. In some cases, it leads to joint destruction that is irreversible.
Approximately 4.5 million Americans suffer from psoriasis, an autoimmune skin disease in which skin cells multiply 10 times faster than the normal rate. The excess cells pile up on the skin’s surface, forming red, raised, scaly plaques that can be painful and disfiguring.
AMEVIVE is a biologic therapy approved to treat adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. AMEVIVE may continue to provide relief after patients stop treatment. In two large controlled clinical studies, some patients with moderate-to-severe chronic plaque psoriasis maintained their response for up to seven months after completing one 12-week course of therapy.
AMEVIVE is the only approved biologic for psoriasis that is eligible for Medicare Part B coverage and has a J code (J0215), which helps accelerate the Medicare reimbursement process.
Important AMEVIVE Safety Information
AMEVIVE reduces the number of T cells. This could increase the possibility of getting an infection or cancer.
Because AMEVIVE reduces the number of T cells, patients should have regular blood tests during the dosing period to monitor T cell levels. If T cell levels are too low, treatment may be postponed or stopped.
Some patients who received AMEVIVE in psoriasis clinical studies developed cancers, including skin cancers, cancers of the organs and the lymph system. Some patients developed serious infections, including wound infections and pneumonia.
AMEVIVE should not be taken by patients who are HIV-positive or are known to be allergic to AMEVIVE or any of its components.
Some patients treated with AMEVIVE have had serious liver injury.
Commonly observed side effects that occurred in clinical studies more frequently with AMEVIVE included sore throat, dizziness, cough, nausea, itching, muscle aches, chills, injection site reactions and accidental injury. If you become pregnant while taking AMEVIVE, tell your doctor and consider enrolling in the Pregnancy Registry by calling 1 (866) AMEVIVE.
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