Abbott Reports Psoriasis Phase III Results of its Investigational IL-12/23 Inhibitor Briakinumab (ABT-874)

By Abbott, PRNE
Sunday, October 10, 2010

Data Compares Briakinumab (ABT-874) to Etanercept, Methotrexate and Placebo in Psoriasis

ABBOTT PARK, Illinois, October 11, 2010 - In four separate pivotal clinical studies presented on Friday, a greater
percentage of moderate to severe chronic plaque psoriasis patients treated
with briakinumab, Abbott's investigational IL-12/23 inhibitor (ABT-874),
achieved 75 percent or better skin clearance rates than those treated with
etanercept (Enbrel(R)), methotrexate or placebo. Abbott (NYSE: ABT) presented
data from all briakinumab pivotal studies in psoriasis at the European
Association of Dermatology and Venereology scientific sessions.

Briakinumab is an investigational biologic medication that targets
IL-12/23 proteins linked to inflammation. Briakinumab is the second
medication in the IL-12/23 class to have completed Phase III trials for the
treatment of plaque psoriasis. The most commonly prescribed biologics used to
treat moderate to severe chronic plaque psoriasis target a protein called
tumor necrosis factor (TNF).

"While anti-TNFs are the cornerstone of biologic treatment for psoriasis,
these data suggest that briakinumab may be evaluated as a potentially
important alternative treatment option for some psoriasis patients," said
Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott.

In the largest of the four studies, a 52-week study comparing briakinumab
(N=981) to placebo (N=484), significantly more patients experienced skin
clearance versus patients with placebo. At week 12, skin clearance of 75
percent (PASI 75) was achieved in 80.7 percent of patients receiving
briakinumab every four weeks versus 4.5 percent with placebo. Skin clearance
of 90 percent (PASI 90) was achieved in 61.6 percent on briakinumab versus
1.4 percent on placebo, and 100 percent skin clearance (PASI 100), was
achieved in 32.2 percent of patients versus no placebo patients. Of the 290
briakinumab patients that achieved PASI 75 and Physician's Global Assessment
(PGA) of clear or normal at week 12, 82.4 percent maintained PASI 75 at week
52, versus 9.0 percent of the 144 patients on placebo.

Of the 243 briakinumab patients that achieved PASI 90 and PGA of clear or
normal at week 12, 81.5 percent maintained PASI 90 at week 52, versus 9.2
percent of the 109 placebo patients. Of the 298 briakinumab patients who
achieved PGA of clear or normal at week 12, 63.4 percent of patients
demonstrated PASI 100 at week 52, versus 4 percent of the 149 placebo
patients.

The most common adverse events observed across all four briakinumab
pivotal studies and the ongoing open-label extension were upper respiratory
infection, nasopharyngitis (stuffy nose), headache, arthralgia (joint pain),
hypertension and back pain. The incidences of infection and malignancy with
briakinumab were generally higher than those with placebo, but were similar
to those in patients treated with etanercept or methotrexate. Because
briakinumab is a modulator of the immune system, these results are not
unexpected and emphasize the need for close monitoring and surveillance.
Major adverse cardiovascular events (MACE) including myocardial infarction,
stroke and cardiovascular death were observed in one of the four briakinumab
pivotal studies and in the ongoing open-label extension. An analysis of the
data showed that all patients experiencing MACE in the pivotal briakinumab
study had identifiable underlying cardiovascular risk factors.

"These clinical trials advance our understanding of the benefits and
risks of inhibiting IL-12/23 proteins with briakinumab in patients with
psoriasis," said Kenneth Gordon, M.D., Head, Division of Dermatology,
NorthShore University Health System.

About the Briakinumab Clinical Program

The following pivotal studies were presented at the European Association
of Dermatology and Venereology scientific sessions in Gothenburg, Sweden,
Oct. 6-10, 2010:

    M10-255 Study
    -- Phase III, 52-week, double-blind, randomized, multi-center, active
       controlled study of 317 patients with moderate to severe psoriasis
       comparing briakinumab to methotrexate treatment
    -- Primary endpoints were based on PASI (Psoriasis Area and Severity
       Index) and PGA measures
    -- At baseline (week 0), patients were randomized to receive briakinumab
       or methotrexate (MTX). The briakinumab treatment group received 200 mg
       at weeks 0 and 4 and 100 mg every 4 weeks from weeks 8 to 48. The MTX
       treatment group received MTX (5 to 25 mg weekly from weeks 0 to 51)
       plus oral folate (5 mg weekly from weeks 0 to 51)
    -- Patients in the MTX group received MTX 5 mg at week 0, 10 mg at week
       1, and 15 mg/wk from weeks 2 to 9. At weeks 10 and 16, MTX dosage was
       increased by 5 mg (to 20 mg/wk at week 10 and 25 mg/wk at week 16) for
       patients who did not achieve PASI >/- 75 or a PGA of 0 or 1
       (indicating clear skin or minimal psoriasis plaques)
    -- The four primary endpoints were percentage of patients with PASI 75 at
       week 24, PGA of 0 or 1 at week 24, PASI 75 at week 52 and PGA score of
       0 or 1 at week 52
    -- At 24 weeks, 81.8 percent of briakinumab patients achieved PASI 75
       clearance compared with 39.9 percent of those taking methotrexate.
       PASI 90 clearance was achieved by 63.6 percent of briakinumab patients
       versus 22.7 percent with methotrexate, while PASI 100 was achieved by
       42.2 percent of briakinumab patients versus 8.6 percent of
       methotrexate patients
    -- At 52 weeks, 66.2 percent of briakinumab patients achieved PASI 75
       clearance compared with 23.9 percent of methotrexate patients. PASI 90
       clearance was achieved by 59.7 percent of briakinumab patients versus
       17.8 percent of those taking methotrexate, while PASI 100 was achieved
       by 45.5 percent of briakinumab patients versus 9.2 percent of
       methotrexate patients
    -- Results on the primary endpoints were statistically significant -
       P<0.001, briakinumab versus methotrexate
    -- The most common adverse events in briakinumab and methotrexate
       reatment groups were nasopharyngitis, headache, diarrhea, arthralgia
       and upper respiratory tract infection
    -- Three cases of malignancies were reported in the briakinumab group
    -- Serious infections were reported by four (2.6 percent) patients in the
       briakinumab group and three (1.8 percent) patients in the MTX group
    -- No MACE were reported for either treatment group
    M06-890
    -- Phase III, 52-week, randomized, multi-center study of 1,465 patients
       comparing the efficacy and safety of two dosing regimens of
       briakinumab to placebo
    -- In an induction phase, patients were first randomized in a 2:1 ratio
       at week 0 to receive briakinumab 200 mg at weeks 0 and 4, followed by
       100 mg at week 8 (n=981), or placebo injections to match briakinumab
       (n=484)
    -- Randomization of those patients who had a clinical response (PGA 0 or
       1) occurred at week 12, with patients receiving briakinumab 100 mg
       every four weeks (n=298), briakinumab 100 mg every 12 weeks (n=298) or
       placebo injections to match briakinumab (n=149)
    -- Co-primary endpoints were proportion of patients achieving PGA 0 or 1
       at week 12; proportion of patients achieving PASI 75 at week 12; and
       proportion of patients achieving PGA 0 or 1 at week 52
    -- Briakinumab was statistically superior to placebo by the primary
       endpoint measures at week 12: 76 percent of patients achieved PGA 0 or
       1 at week 12 compared to 4.3 percent with placebo and 80.7 percent
       achieved PASI 75 at week 12 compared to 4.5 percent with placebo
    -- At 52 weeks, 79.2 percent of patients treated every four weeks with
       briakinumab achieved PGA 0 or 1 compared to 41.6 percent treated every
       12 weeks with briakinumab and 6 percent treated with placebo
    -- Results on the primary endpoints were statistically significant -
       P<0.001, briakinumab versus placebo
    -- A higher incidence of infection and skin malignancy adverse events
       were observed in briakinumab versus placebo-treated patients
    -- Seven cases of major adverse cardiovascular events were reported in
       the briakinumab group compared with no events in the placebo group
       during the 12-week randomized phase
    M10-114 Study
    -- Phase III, 12-week, double-blind, double-dummy, randomized
       multi-center study in 347 patients with moderate to severe psoriasis
       comparing the efficacy and safety of treatment with briakinumab
       (n=138) to etanercept (n=141) and placebo (n=68)
    -- Patients were randomized to receive briakinumab 200 mg at weeks 0 and
       4, then 100 mg at week 8; etanercept 50 mg twice weekly; or placebo
       injection to match briakinumab and etanercept
    -- There were two co-primary endpoints at week 12 - proportion of
       patients achieving PGA 0 or 1 and proportion of patients achieving
       PASI 75
    -- Briakinumab was statistically superior to both etanercept and placebo
       on both primary endpoint measures, with 71 percent of
       briakinumab-treated patients achieving PGA 0 or 1 (39.7 percent with
       etanercept, 2.9 percent with placebo) and 81.9 percent of
       briakinumab-treated patients achieving PASI 75 (56 percent with
       etanercept, 7.4 percent with placebo)
    -- Results on the primary endpoints were statistically significant -
       P<0.001, briakinumab versus etanercept and P<0.001, briakinumab versus
       placebo
    -- A slightly higher percentage of patients receiving etanercept or
       briakinumab experienced adverse events as compared with patients
       receiving placebo, however the safety profile for the two active
       treatments was similar
    -- No differences were seen across the active treatment groups for the
       percentage of patients experiencing serious infections or malignancies
    -- No MACE were reported in any treatment group
    M10-315 Study
    -- Phase III, 12-week, double-blind, double-dummy, randomized
       multi-center study in 350 patients with moderate to severe psoriasis
       comparing the efficacy and safety of treatment with briakinumab
       (n=139) to etanercept (n=139) and placebo (n=72)
    -- Patients were randomized to receive briakinumab 200 mg at weeks 0 and
       4, then 100 mg at week 8; etanercept 50 mg twice weekly; or placebo
       injection to match briakinumab and etanercept
    -- There were two co-primary endpoints at week 12 - proportion of
       patients achieving PGA 0 or 1 and proportion of patients achieving
       PASI 75
    -- Briakinumab was superior to both etanercept and placebo on both
       primary endpoint measures, with 72.7 percent of briakinumab-treated
       patients achieving PGA 0 or 1 (29.5 percent with etanercept, 4.2
       percent with placebo) and 80.6 percent of briakinumab-treated patients
       achieving PASI 75 (39.6 percent with etanercept and 6.9 percent with
       placebo)
    -- Results on the primary endpoints were statistically significant -
       P<0.001, briakinumab versus etanercept and P<0.001, briakinumab versus
       placebo
    -- A higher percentage of patients in the briakinumab and entanercept
       treatment groups experienced adverse events than patients in the
       placebo group (50.4 percent, 49.6 percent, and 44.4 percent,
       respectively)
    -- The frequently reported adverse events occurring in at least 5 percent
       of patients in both the briakinumab and etanercept treatment groups
       were upper respiratory tract infection (7.2 percent and 11.5 percent,
       respectively) and nasopharyngitis (7.2 percent and 7.9 percent,
       respectively)
    -- Eight patients experienced malignancies: three cases in the
       briakinumab treatment group, four cases in the etanercept treatment
       group, and one case in the placebo group
    -- No cases of serious infection were reported in any of the groups
    -- No MACE were reported in any treatment group

About Abbott

Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs nearly 90,000 people and markets its products in more than
130 countries.

Abbott's news release and other information are available on the
company's Web site at www.abbott.com

U.S. Media, Elizabeth Hoff, +1-847-935-4236, or International Media, Ana-Paula Barboza, +1-847-938-2144, or Financial, Larry Peepo, +1-847-935-6722, all of Abbott

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