Remittive effects of intramuscular alefacept in psoriasis

Journal of Drugs in Dermatology, Dec, 2003 by Kenneth B Gordon, Richard G Langley

A second course of IM alefacept was well tolerated. The incidence of adverse events was similar to that reported following a single course of therapy, and the type of adverse events showed no evidence of organ toxicity or generalized immunosuppression with repeated dosing. As expected from its fully human composition, the immunogenicity associated with alefacept remained negligible over the second course of therapy.

Alefacept is the first biologic agent approved for the treatment of moderate to severe chronic plaque psoriasis. Long-term control of the disease without the need for routine or maintenance therapy can be achieved with alefacept. In addition, concerns over the safety of conventional agents, particularly for multi-organ system toxicity, are alleviated with alefacept. Repeated dosing offers additional benefits and does not seem to increase the incidence of adverse events or immunogenicity. Research is ongoing to further optimize the use of this new biologic agent, including use in combination with other therapies for moderate to severe psoriasis and alternative dosing strategies.

Table 1.
Baseline demographics and disease characteristics

                            Two Courses of Alefacept 15 mg IM
                                                      (n=131)

Median age(range) *, yrs                           46 (19-78)
Gender *, n (%)
Male                                                  85 (65)
Female                                                46 (35)

Race *, n (%)
White                                                124 (95)
Hispanic                                                4 (3)
Black                                                   2 (2)
Asian                                                  1 (<1)

Median BSA involvement ([dagger]), % (range)        15 (1-85)

Median PASI ([dagger]), (range)                9.6 (1.8-52.5)

PGA ([dagger]), n (%)
Severe                                                 12 (9)
Moderate to severe                                    25 (19)
Moderate                                              37 (28)
Mild to moderate                                      27 (21)
Mild                                                  30 (23)

* At baseline of the phase 3 study.

([dagger]) At baseline of the extension study.

BSA = body surface area; PASI = Psoriasis Area Severity Index;
PGA = Physician Global Assessment.

Table 2:
Adverse events reported in at least 5% of patients
during the second course of alefacept 15 mg IM

Adverse Event          Course 1    Course 2
                       (n=166) *   (n=131)

Headache               30 (18)     11 (8)
Pruritus               30 (18)     9 (7)
Infection ([dagger])   26 (16)     30 (23)
Accidental injury      16 (10)     22 (17)
Pharyngitis            20 (12)     16 (12)
Flu syndrome           17 (10)     9 (7)
Viral infection        11 (7)      10 (8)
Rhinitis               9 (5)       14 (11)
Abdominal pain         8 (5)       7 (5)
Hypertension           8 (5)       7 (5)
Bronchitis             6 (4)       7 (5)

Numbers in parentheses are percentages.

* Data from reference #11.

([dagger]) The majority of episodes were common colds.

Figure 4. Overall response rates after 1 and 2 courses of alefacept
15 mg IM.
                               1 Course of       2 Courses of
                             Alefacept 15 mg   Alefacept 15 mg

[greater than or equal to]
50% PASI Reduction                  57                69

[greater than or equal to]
75% PASI Reduction                  33                43

PGA of "Clear" or
"Almost Clear"                      24                31

Note: Table made from bar graph.