Abbott PowerPoint Slide Style Guide

PowerPoint Slide
Style Guide
Introduction and overview
This style guide aims to help you design Abbott speaker slide decks that have a uniform
and consistent look both within the deck itself and among multiple decks we create for
our client.
• his guide presumes you have a working knowledge of PowerPoint and are familiar with
T
PowerPoint templates.
• his style guide is designed to show you how to use our pre-designed templates to create
T
slides for the majority of layout situations you will encounter.
• For the writer, the various font sizes and colors are already “built in” to the template, so you
should be able to just start typing.
• Using the templates will insure that all slides have a consistent visual look regarding
background image, style and color of text and placement of images. This should also make
deck creation easier and more efficient.
• This Style guide will evolve and be updated as we learn together the best way to build
great PowerPoint decks for our client!
2
Important Do’s and Don’ts
Do’s:
• Please use the template to build your slide from scratch—rather than creating the
content in a Word document first. Doing so will allow you to “see” the look of your
slide immediately, and help you appreciate total content per slide (and indicate
when it’s time to start a new slide!).
• Lookthrough this guide before you start, to identify the various templates at your
disposal, and pick the right template on which to build your slide.
• Remember to keep in mind that when insertions are used (pictures, charts, video.),
you will need to involve your art director to insure that they meet HUMIRA branding
guidelines and are of sufficient resolution and quality.
Don’t:
• Please try not to move any of the objects on the slide, such as the positioning of text
or art boxes. Your Art Director will provide a final consistency styling check at key
intervals (and especially as the project nears completion), but will be greatly aided
by your preservation of template settings.
• Try
not to make any changes to the template. If something is not fitting/working, work
with your Art Director to find a solution.
• D
on’t add or remove branding elements (“Abbott” or “HUMIRA”)—if a given slide
needs to be altered (eg, per MLR direction), have, an Art Director make this change.
3
Table of Contents
Background templates....................................................................................... 5
Title slide....................................................................................................... 6
Title with description text.................................................................................... 7
Slide picture on left........................................................................................... 8
Slide picture-middle.......................................................................................... 9
Text without bullets......................................................................................... 10
ISI slide................................................................................................... 11-12
Slide with chart.. ........................................................................................ 13-15
Slide with table.............................................................................................. 16
Master view thumbnails.. .............................................................................. 17-18
Chart and table font styles defined................................................................... 19-20
Note pages defined......................................................................................... 21
Global Specifications....................................................................................... 22
Background templates
These are the ONLY authorized background templates. Using them on all branded and unbranded
slide decks will result in a consistent visual presentation.
Branded template
Background
Abbott Sponsorship DisclosureAbbott Sponsorship Disclosure

• In 1997, adalimumab, the first fully human monoclonal antibody targeted
against TNF, was first administered to a study patient
– HUMIRA is a recombinant human IgG1 monoclonal This
This program is sponsored by, and on behalf of, Abbott, and the antibodyprogram specific for
is sponsored by, and on behalf of, Abbott, and the
Ankylosing Spondylitis Ankylosing Spondylitis
human TNF. HUMIRA was created using phage display technology
presentation contents are consistent within an
resulting allantibody
applicable FDA heavy and
with human-derived presentation
light chain contents are consistent with all applicable FDA
variable regions and human IgG1:k constant regions
requirements. The Speaker for this program has been selected by requirements. The Speaker for this program has been selected by
•Abbott Sponsorship
This report represents Disclosure
a safety analysis of adalimumab across six Abbott Sponsorship Disclosure
Abbott and is presenting the program material on Abbott’s behalf. Abbott and is presenting the program material on Abbott’s behalf.
Ankylosing Spondylitis immune-mediated inflammatory diseases
This program is sponsored by, and on behalf of, Abbott, and the
presentation contents are consistent with all applicable FDA
• Authors evaluated safety data from approximately 10 years of
requirements. The Speaker
adalimumab clinical for this program has been selected by
trial experience requirements. The Speaker for this program has been selected by
Abbott and is presenting the program material on Abbott’s behalf. Abbott and is presenting the program material on Abbott’s behalf.
2/23/2011
2/23/2011
2/23/2011
2/23/2011
2/23/2011
Burmester GR, Mease P, Dijkmans BAC, et al. Adalimumab safety and mortality rates from global clinical trials of
six immune-mediated inflammatory diseases. Ann Rheum Dis. 2009;68:1863-1869.
HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories.
Please see Important Safety Information, including BOXED WARNING on

Serious Infections and Malignancy, on slides 5-8.
Please see Abbott Representative for full Prescribing Information.
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3 64V-304709
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Title slide Interior slides with logo Interior slides without logo
Unbranded templates
AbbottSponsorshipDisclosure
This Program is sponsored by, and on behalf of, Abbott. The presentation
contents are consistent with all applicable FDA requirements, including
FDA-approved product labeling. The Speaker for this Program has been
selected by Abbott and is presenting the Program material on Abbott’s behalf.
Title slide Interior slides
5
Title slide
Safety Area
7.65 inch x 6.7 inch
.5”
FPO
2”
Ankylosing Spondylitis
Center vertically
Flush left to safety
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Text; Arial 36
points, Black
Leading 38
Flush Left
Use this Slide Master PowerPoint Fonts
6
Slide with descriptive text
.5”
Important Safety Considerations (cont.)
SERIOUS INFECTIONS (continued)

The risks and benefits of treatment with HUMIRA should be carefully considered prior to
initiating therapy in patients with chronic or recurrent infection. Patients should be closely
2” monitored for the development of signs and symptoms of infection during and after
Abbott Sponsorship Disclosure

treatment with HUMIRA, including the possible development of TB in patients who tested
negative for latent TB infection prior to initiating therapy.
FPO
MALIGNANCY Center vertically
Lymphoma and other malignancies, some fatal, have been reported in children
Flush left to safety
and adolescent patients treated with TNF blockers, of which HUMIRA is a member.
• requirements.
Malignancies The
– Seen more often thanSpeaker for this non-melanoma
in controls. Lymphoma, program has skin been selected by
Abbott and is presenting the program material on Abbott’s behalf.
cancer, acute and chronic leukemia, and others have been reported.
• Hypersensitivity – Anaphylaxis or serious allergic reactions may occur.

Stop HUMIRA and begin appropriate therapy.
2/23/2011
2/23/2011

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36 Points. RGB-214,0,87 18 Points Arial italic

Flush left, exact leading Black, Flush left
exact leading 20 points
7
Slide -picture on left
Headline starts at edge of safety area
text box vertical alignment must be set to “top”
Arial Bold=24 points single line leading RGB=214, 0, 87
Ankylosing Spondylitis (AS) Bullets: 115% size

RGB-214,0,87
• Chronic inflammatory disease
Text; Arial 18
– Saxial skeleton points, Black,
– Peripheral joints Sub-bullets
All images
• Sites affected
– Entheses
16 points,
Bullets and
and text
2” sub-bullets
• Clinical signs/symptoms require
– Chronic inflammatory back pain consistent
spacing
FPO
– Sacroiliitis
– Impaired spinal mobility leading
– Reduction of chest expansion 16 points
– Enthesitis space after
6 points
• Radiographic hallmark: sacroiliitis
• Absence of rheumatoid factor Leading between
• Association with HLA-B27 sub-bullets
16 points no
space after or
before
van der Heijde D. In: Klippel JH et al, eds. Primer on the Rheumatic Diseases. 13th ed. 2008;193-199.
van der Linden S et al. In: Firestein GS et al, eds. Kelley’s Textbook of Rheumatology, 8th ed. 12 points
64V-304709 4 Space after
Text 100% Black 8 points/10 points Page Number: 100% Black

8 points. centered on yellow bar
Code: Arial 8 pts,white, aligns with page
number bottom
Picture Flush left

Use maximum height
Size with white space
align with Text
8
Slide -picture in middle
Bullets:
Headline starts at edge of safety area 115% size
text box vertical alignment must be set to “top” RGB=214,0,87
Arial Bold=24 points single line leading RGB=214, 0, 87 Text; Arial 16
points, Black
Indentation 0.2
Hanging 0.2
Sacroiliitis Spacing Before
All images
12 points
• Synovitis/enthesitis After 6 points
• Cartilage destruction/bone erosions Exact leading
• Bony ankylosis
and text FPO
• New bone formation 16 points
Text box
Layout vertical
2” alignment “Top”
Sacroiliac joints in an AS patient
Text and graphic
content vertically
centered within
“safety area”
van der Heijde D. In: Klippel JH et al, eds. Primer on the Rheumatic Diseases. 13th ed. 2008;193-199.
Francois RJ et al. Arthritis Rheum. 2000;43:2011-2024.
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Text 100% Black 8 points./10 points Image Flush

Page Number: 100%
left use width of safety for sizing
Black 8 points. centered on
Picture Flush left use maximum
yellow bar
width. Size with white space

number bottom
9
Slide -text without bullets
AS and RA Indications
HUMIRA is indicated for reducing signs and symptoms in adult patients
with active ankylosing spondylitis.
HUMIRA is indicated for reducing signs and symptoms, inducing major

clinical response, inhibiting the progression of structural damage and
improving physical function in adult patients with moderately to severely
2” active rheumatoid arthritis.
FPO
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Text 100% Black 8 points./10 points. Page Number: 100% Black

Arial Bold & Regular 18 points.
Text box vertical alignment “Bottom” 8 points. centered on yellow bar
no indent 6 points. before
6 points after
single space leading
Code: Arial 8 pts,white, aligns with page Text box Layout vertical
number bottom alignment “Top”
10
Slide -ISI
Important Safety Considerations

1.4
WARNINGS
Important Safety
SERIOUS Considerations (cont.)
INFECTIONS
Patients treated with HUMIRA are at increased risk for developing serious infections that
may lead to hospitalization or death. Most patients who developed these infections were
SERIOUS taking concomitant immunosuppressants such as methotrexate or corticosteroids. HUMIRA
INFECTIONS (continued)
The risks and benefitsbe
should discontinued
of treatment if a patient
with HUMIRA shoulddevelops a serious
be carefully infection
considered prior to or sepsis. Reported
2” infections
initiating therapy include:
in patients with chronic or recurrent infection. Patients should be closely
FPO
monitored for the development of signs and symptoms of infection during and after
treatment with• HUMIRA,
Active tuberculosis (TB), including
including the possible developmentreactivation of latent
of TB in patients who TB. Patients with TB have
tested
negative for latent TB infection
frequently prior to initiating
presented therapy.
with disseminated or extrapulmonary disease. Patients should be
tested for latent TB before HUMIRA use and during therapy. Treatment for latent infection
MALIGNANCY
should be initiated prior to HUMIRA use.
and adolescent
• patients
Invasivetreated
fungalwith TNF blockers,
infections, of whichhistoplasmosis,
including HUMIRA is a member.
coccidioidomycosis, candidiasis,
aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other
• Malignanciesinvasive
– Seen more often
fungal than in controls.
infections Lymphoma,
may present non-melanomarather
with disseminated, skin than localized, disease.
cancer, acute Antigen
and chronic
andleukemia,
antibodyand others
testing forhave been reported.
histoplasmosis may be negative in some patients with
active infection. Empiric anti-fungal therapy should be considered in patients at risk for
• Hypersensitivity – Anaphylaxis
invasive or seriouswho
fungal infections allergic reactions
develop maysystemic
severe occur. illness.
Stop HUMIRA and begin appropriate therapy.
Bacterial, viral and other infections due to opportunistic pathogens.
2/23/2011
2/23/2011


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Text 100% Black 8 points/10 points. Page Number: 100% Black Arial Bold 12 points.
8 points. Centered on yellow bar no indent 6 points. before
6 points after
single space leading
Text box Layout vertical
alignment “Top”
number bottom
Arial Bold 12 points, Flush left, edge of safety area text inset 0.2 equal sides
1 pt Black rule
Bullets :RGB=214, 0, 87
11
Slide -ISI continued
Important Safety Considerations (cont.) Important Safety Considerations (cont
ISI slides are already formatted.
Just copy and paste into your new presentation.
SERIOUS INFECTIONS (continued) SERIOUS INFECTIONS (continued)
The risks and benefits of treatment with HUMIRA should be carefully considered prior to The risks and benefits of treatment with HUMIRA should be carefully consi
1. monitored for the development of signs and symptoms of infection during and after 2.
initiating therapy in patients with chronic or recurrent infection. Patients should be closely initiating therapy in patients with chronic or recurrent infection. Patients s
monitored for the development of signs and symptoms of infection during
Important
treatment with Safety Considerations
HUMIRA, 1
including the possible development of TB in patients who tested Important Safety
treatment with Considerations
HUMIRA, (cont’d)
including the possible
1
development of TB in patie
negative1.4 for latent TB infection prior to initiating therapy. 1.4 for latent TB infection prior to initiating therapy.
negative
2 WARNINGS 2 SERIOUS INFECTIONS (continued)
MALIGNANCY
SERIOUS INFECTIONS MALIGNANCY
FPO
initiating therapy in patients with chronic or recurrent infection. Patients should be closely
Lymphoma and
Patients treated with other
HUMIRA malignancies,
are at some serious
increased risk for developing fatal,infections
have beenthat reported in children Lymphoma
monitored and other
for the development malignancies,
of signs and symptoms ofsomeinfectionfatal, have
during and after been reported in child
FPO
and
taking adolescent patients treated
concomitant immunosuppressants such as with TNF orblockers,
methotrexate ofHUMIRA
corticosteroids. which HUMIRA is a member. treatment with HUMIRA, including the possible development of TB in patients who tested
and adolescent patients treated with TNF blockers, of which HUMIRA is a m
should be discontinued if a patient develops a serious infection or sepsis. Reported
infections include:
MALIGNANCY
• • Malignancies
Active tuberculosis (TB),– Seenreactivation
including more often than
of latent TB. in with
Patients controls.
TB have Lymphoma, non-melanoma skin •Lymphoma
Malignancies – Seen
and other malignancies, more
some often
fatal, have than ininchildren
been reported controls. Lymphoma, non-
frequently presented with disseminated or extrapulmonary disease. Patients should be
cancer, acute
tested for latent and
TB before chronic
HUMIRA use and leukemia, and others
during therapy. Treatment have been reported.
for latent infection
cancer, acute and chronic leukemia, and others have been reported
• Malignancies – Seen more often than in controls. Lymphoma, non-melanoma skin
• • Hypersensitivity – Anaphylaxis
Invasive fungal infections, including or serious allergic
histoplasmosis, coccidioidomycosis, candidiasis,reactions may occur. • cancer,
Hypersensitivity – Anaphylaxis
acute and chronic leukemia, and others haveor serious
been reported. allergic reactions may oc
Stop
invasiveHUMIRA and
fungal infections begin
may present appropriate
with therapy.
disseminated, rather than localized, disease. Stop HUMIRA
• Hypersensitivity and begin
– Anaphylaxis appropriate
or serious allergic reactionstherapy.
may occur.
Antigen and antibody testing for histoplasmosis may be negative in some patients with Stop HUMIRA and begin appropriate therapy.
active infection. Empiric anti-fungal therapy should be considered in patients at risk for
invasive fungal infections who develop severe systemic illness.

2/23/2011
HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories. 2/23/2011 HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories.
Please see Abbott Representative for full Prescribing Information. Please see Abbott Representative for full Prescribing Information.
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HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories. HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories.
Important
Important Safety
Safety Considerations
Considerations (cont.)
(cont.)
Please see Abbott Representative for full Prescribing Information. Important Safety for
Please see Abbott Representative Considerations
full Prescribing Information. (cont
64V-304709 64V-304709 7 7
SERIOUS INFECTIONS (continued) SERIOUS INFECTIONS (continued)

The risks and benefits of treatment with HUMIRA should be carefully considered prior to The risks and benefits of treatment with HUMIRA should be carefully consi
The riskstherapy
and benefits of treatment with HUMIRA should be carefully considered prior to
3.
initiating in patients with chronic or recurrent infection. Patients should be closely
initiating therapy in patients with chronic or recurrent infection. Patients
should
and
be
after
closely 4.
initiating therapy in patients with chronic or recurrent infection. Patients sh
Important
treatment with
treatment
Safety
with
HUMIRA,
HUMIRA,
Considerations
including the
(cont’d)
including the possible
possible
1
development of TB in patients who tested Important
development of TB in patients who tested
treatment with Safety Considerations
HUMIRA, including the possible(cont’d) 1
development of TB in patien
2 negative for latent TB infection prior to initiating therapy.
1.4 for latent TB infection prior to initiating therapy. 2 negative1.4 for latent TB infection prior to initiating therapy.
negative
• Anakinra – Increased risk of serious infections. Combination of • Hepatitis B reactivation – Increased risk of reactivation in patients who
MALIGNANCY
HUMIRA and anakinra is not recommended. MALIGNANCY
are chronic carriers. Some cases have been fatal. If reactivation occurs,
MALIGNANCY
•Lymphoma
Live vaccinesand other
– Should notmalignancies, some
be given to patients fatal, have been reported in children
on HUMIRA. stop HUMIRAand
Lymphoma and begin
otheranti-viral therapy. some fatal, have been reported in child
malignancies,
Lymphoma
and and patients
adolescent other malignancies,
treated with some fatal, have
TNF blockers, of been
whichreported
HUMIRAinischildren
a member.
and adolescent patients treated with TNF blockers, of which HUMIRA is a member. •and adolescent
Demyelinating patients
disease treated with
– Exacerbation TNF
or new blockers,
onset of which HUMIRA is a m
may occur.
FPO
Exercise caution when considering HUMIRA for patients with these
FPO
• Malignancies – Seen more often than in controls. Lymphoma, non-melanoma skin• disorders.
• Malignancies – Seen more often than in controls. Lymphoma, non-melanoma skin • Malignancies – Seen more often than in controls. Lymphoma, non-m
Hematological reactions – Cytopenias, pancytopenia. Advise patients to
cancer, acute and chronic leukemia, and others have been reported. cancer, acute and chronic leukemia, and others have been reported
cancer, acute and chronic leukemia, and others have been reported. seek immediate medical attention if symptoms develop, and consider
stopping HUMIRA.
• Hypersensitivity – Anaphylaxis or serious allergic reactions may occur. • Hypersensitivity – Anaphylaxis or serious allergic reactions may oc
• Hypersensitivity – Anaphylaxis or serious allergic reactions may occur. • Heart failure – Worsening or new onset CHF may occur. Exercise
Stop HUMIRA and begin appropriate therapy. Stop HUMIRA and begin appropriate therapy.
Stop HUMIRA and begin appropriate therapy. caution when using HUMIRA in patients who have heart failure and
• Discontinuations due to adverse events were 7% for HUMIRA vs monitor them carefully.
4% for placebo
• Autoimmunity – Development of autoantibodies and lupus-like
• In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis, syndrome. Stop HUMIRA if lupus-like syndrome
Crohn’s disease, and plaque psoriasis the safety profile for patients
2/23/2011
2/23/2011
2/23/2011
treated with HUMIRA was similar to the safety profile seen in patients
with rheumatoid arthritis.
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ISI layouts
1. 2. 3. 4.
12
Slide with chart
.5”
PREMIER 2-Year Study Design

Early Moderate to Severe RA
All images
and text
2” Chart placed
as jpg from
Illustrator File
with Text to
FPO unify font
aEOW=every other week. bIntent-to-treat population.

cStable doses of concomitant NSAIDs and
corticosteroids were permitted. Patients taking MTX escalated to 20 mg/wk by Week 8, as
needed/as tolerated.
Breedveld FC et al. Arthritis Rheum. 2006;54:26-37.
64V-304709 8

Hanging 0.2 Spacing Before 0 points 8 points. Centered on yellow bar
After 6 points Leading Exact 10 points
Text box vertical alignment “Bottom”

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Use this Slide Master PowerPoint Fonts Charts Fonts

Helvetica Neue (T1)
47 Light Condensed
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57 Condensed
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77 Bold Condensed
Helvetica Neue (T1)
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13
Slide with chart
.5”
PREMIER: Mean Change From Baseline

in mTSS2
All images
The risks and benefits of treatment with HUMIRA should be carefully considered
prior to initiating therapy in patients with chronic or recurrent infection. Patients
and text
should be closely monitored for the development of signs and symptoms of
infection during and after treatment with HUMIRA, including the possible
2” development of TB in patients who tested negative for latent TB infection prior to
Chart placed
initiating therapy.
as jpg from
MALIGNANCY
FPO
Illustrator File
with Text to
unify font
size to maxium
width
a EOW=every other week.

b Intent-to-treat population. cStable doses of concomitant NSAIDs and c orticosteroids were permitted.
Patients taking MTX escalated to 20 mg/wk by Week 8, asneeded/as tolerated.

64V-304709 10

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14
Slide with chart
ACR50/70 Response Rates at Years 1 and 2 .5”
ACR50/70 Response Rates at Years 1 and 2
All images
2”
and text Chart placed

as jpg from
FPO
Illustrator File
with Text to
unify font
a Analysis
is of the intent-to-treat (ITT) study population using nonresponder imputation (NRI)
aBreedveld FC
Analysis is of
et al. Arthritis Rheum. 2006;54:26-37
the intent-to-treat (ITT) study population using nonresponder imputation (NRI)
Breedveld FC et al. Arthritis Rheum. 2006;54:26-37
Please see Important Safety Information, including BOXED WARNING

on Serious Infections and Malignancy, beginning on slide 40.
Please see Important Safety Information, including BOXED WARNING
on Serious Infections and Malignancy,12beginning on slide 40.
64V-304709 12
Text 100% Black 8 points/10 points

Hanging 0.2
Page Number: 100% Black
Code: Arial 8 pts,white, aligns with page 8 points centered on yellow bar
number bottom
Arial Bold Flush left, 12 points

Helvetica Neue (T1)
47 Light Condensed
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57 Condensed
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77 Bold Condensed
Helvetica Neue (T1)
97 Black Condensed
15
Slide with table
Baseline Characteristics * line leading RGB=214, 0, 87
Arial Bold=24 points single
.5”
Baseline Characteristics*
All images
2”
and text Table placed
as jpg from
Illustrator File
FPO
with Text to
unify font
size to
maximum
width
Unless otherwise indicated, results are mean ± SD.

a n=267
Unless in the HUMIRA
otherwise + MTX
indicated, group,are
results 271 in the
mean HUMIRA monotherapy group, and 251 in the MTX
± SD.
Breedveld
a n=267 FCHUMIRA
in the et al. Arthritis
+ MTXRheum.
group,2006;54:26-37
271 in the HUMIRA monotherapy group, and 251 in the MTX
11
Breedveld FC et al. Arthritis Rheum. 2006;54:26-37
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8 points. centered on yellow bar
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Use this Slide Master PowerPoint Fonts Table Fonts:

Helvetica Neue (T1)
57 Condensed
Helvetica Neue (T1)
77 Bold Condensed
Helvetica Neue (T1)
97 Black Condensed
16
Thumbnail
Specific master
view slide
of Master
layouts
Slide Layout names
Title all caps Title with italic text Headline with text
Case Study
• A 30-year-old white male construction worker referred by

orthopedist for evaluation of low back pain and abnormal
spine imaging studies
• History: Five-year history of on-and-off low back pain. Pain

is prominent in the morning and associated with stiffness.
OTC NSAIDs have been somewhat helpful, but now the pain
Abbott Sponsorship Disclosure
Ankylosing
nkylosing Spondylitis
is becoming more frequent and persistent. X-rays showed
This Program is sponsored by, and on behalf of, Abbott. The presentation bilateral sacroiliitis
contents are consistent with all applicable FDA requirements, including FDA-
approved product labeling. The Speaker for this program has been selected by
– Other ROS reveals enthesitis of Achilles tendon
Abbott and is presenting the Program material on Abbott’s behalf.
• What other diagnostic test(s) would you order?
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Headline with bullets and picture Head with picture Headline with text
Ankylosing Spondylitis (AS) Sacroiliitis AS and RA Indications
• Chronic inflammatory disease • Synovitis/enthesitis HUMIRA is indicated for reducing signs and symptoms in adult
– Saxial skeleton
• Cartilage destruction/bone erosions patients with active ankylosing spondylitis.
• Peripheral joints
• Sites affected • New bone formation HUMIRA is indicated for reducing signs and symptoms, inducing
– Entheses major clinical response, inhibiting the progression of structural
• Bony ankylosis
damage and improving physical function in adult patients with
• Clinical signs/symptoms moderately to severely active rheumatoid arthritis.
Sacroiliac joints in an AS patient
– Chronic inflammatory back pain
– Sacroiliitis
– Impaired spinal mobility
– Reduction of chest expansion
– Enthesitis
• Radiographic hallmark: sacroiliitis
• Absence of rheumatoid factor
• Association with HLA-B27
van der Heijde D. In: Klippel JH et al, eds. Primer on the Rheumatic Diseases. 13th ed. 2008;193-199. van der Heijde D. In: Klippel JH et al, eds. Primer on the Rheumatic Diseases. 13th ed. 2008;193-199.
van der Linden S et al. In: Firestein GS et al, eds. Kelley’s Textbook of Rheumatology, 8 th ed. van der Linden S et al. In: Firestein GS et al, eds. Kelley’s Textbook of Rheumatology, 8th ed. HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories.
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ISI 1 Head with chart Headline with chart

Important Safety Considerations1 PREMIER 2-Year Study Design Disease Course
WARNINGS
SERIOUS INFECTIONS
Patients treated with HUMIRA are at increased risk for developing serious infections that
taking concomitant immunosuppressants such as methotrexate or corticosteroids. HUMIRA
should be discontinued if a patient develops a serious infection or sepsis. Reported
infections include:
• Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have
frequently presented with disseminated or extrapulmonary disease. Patients should be
tested for latent TB before HUMIRA use and during therapy. Treatment for latent infection
Image reproduced with permission from the
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, American College of Rheumatology.
invasive fungal infections may present with disseminated, rather than localized, disease. • AS does not follow a single defined course
Antigen and antibody testing for histoplasmosis may be negative in some patients with
active infection. Empiric anti-fungal therapy should be considered in patients at risk for • Highly variable, characterized by spontaneous remission and exacerbation
invasive fungal infections who develop severe systemic illness.
• Disease may remain active for decades
• Predictive factors for severe disease include early hip involvement
aEOW=every other week. bIntent-to-treat population.

cStable doses of concomitant NSAIDs and
corticosteroids were permitted. Patients taking MTX escalated to 20 mg/wk by Week 8, as
HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories. needed/as tolerated.
Please see Abbott Representative for full Prescribing Information. Breedveld FC et al. Arthritis Rheum. 2006;54:26-37. van der Linden S et al. In: Firestein GS et al, eds. Kelley’s Textbook of Rheumatology, 8th ed. 2008;1169-1189.
64V-304709 17 64V-304709 7 64V-304709 8
17
Specific Master Slide Layouts (continued)
Headline with chart Headline with chart Headline with chart
PREMIER 2-Year Study Design Baseline Characteristics* ACR50/70 Response Rates at Years 1 and 2
development of TB in patients who tested negative for latent TB infection prior to
initiating therapy.
MALIGNANCY

a n=267in the HUMIRA + MTX group, 271 in the HUMIRA monotherapy group, and 251 in the MTX
a Analysis
is of the intent-to-treat (ITT) study population using nonresponder imputation (NRI)
a EOW=every other week. Breedveld FC et al. Arthritis Rheum. 2006;54:26-37
Patients taking MTX escalated to 20 mg/wk by Week 8, asneeded/as tolerated. Please see Important Safety Information, including BOXED WARNING
Breedveld FC et al. Arthritis Rheum. 2006;54:26-37. on Serious Infections and Malignancy, beginning on slide 40.
9 64V-304709 10
64V-304709 11
Title centered no logo Headline with text ISI 1 indent

Conclusions – ATLAS Important Safety Considerations (cont’d)1
• More patients treated with HUMIRA achieved ASAS20 (the

primary endpoint) compared to placebo patients at week 12 (58% SERIOUS INFECTIONS (continued)
vs 21%) initiating therapy in patients with chronic or recurrent infection. Patients should be closely
HUMIRA® (adalimumab):
• HUMIRA showed statistically significant difference compared to treatment with HUMIRA, including the possible development of TB in patients who tested
ATLAS (the Adalimumab Trial

placebo in ASAS50, ASAS70, BASDAI, BASFI, BASMI, CRP, and
MASES MALIGNANCY
Evaluating Long-term Efficacy

• Patients treated with HUMIRA had significant improvements in and adolescent patients treated with TNF blockers, of which HUMIRA is a member.
and Safety in AS)

SF-36 PCS and ASQOL scores
• Malignancies – Seen more often than in controls. Lymphoma, non-melanoma skin
cancer, acute and chronic leukemia, and others have been reported.
• In HUMIRA clinical trials for ankylosing spondylitis, the safety
profile for patients treated with HUMIRA was similar to the safety • Hypersensitivity – Anaphylaxis or serious allergic reactions may occur.
profile seen in patients with rheumatoid arthritis Stop HUMIRA and begin appropriate therapy.

15 64V-304709 18
ISI 2 box and text ISI with chart

Important Safety Considerations (cont’d) Important Safety Considerations (cont’d)1
• Hepatitis B reactivation – Increased risk of reactivation in patients who • Anakinra – Increased risk of serious infections. Combination of
are chronic carriers. Some cases have been fatal. If reactivation occurs, HUMIRA and anakinra is not recommended.
stop HUMIRA and begin antiviral therapy
• Live vaccines – Should not be given to patients on HUMIRA.
• Demyelinating disease – Exacerbation or new onset of central and
peripheral disease, including multiple sclerosis and Guillain-Barré syndrome,
may occur. Exercise caution when considering HUMIRA for patients with
preexisting or recent-onset central or peripheral nervous system
demyelinating disorders
• Hematological reactions – Cytopenias, pancytopenia. Advise patients to

seek immediate medical attention if symptoms develop, and consider
stopping HUMIRA
• Heart failure – Worsening or new-onset CHF may occur. Exercise caution

when using HUMIRA in patients who have heart failure, and monitor them • Discontinuations due to adverse events were 7% for HUMIRA vs
carefully 4% for placebo
• Autoimmunity – Development of autoantibodies and lupus-like syndrome. • In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis,
Stop HUMIRA if lupus-like syndrome develops Crohn’s disease, and plaque psoriasis the safety profile for patients
treated with HUMIRA was similar to the safety profile seen in patients
with rheumatoid arthritis.
64V-304709 14 64V-304709 20
18
Chart styles and details
12 Extrapolated analysis a HUMIRA 40 mg EOW + MTX (n=268)

Legend:
MTX (n=257)
MEAN CHANGE FROM BASELINE
All Caps 8 pts Helvetica Neue

10
b
P<0.001. 10.4
47 light Condensed
Upper left corner
FPO
8
5X
GREATER
6 INHIBITION
5.7
4
3.5
1.9b
2 1.3b
0.8 b
0 Rule, tick grid, weight: .05

26 52 78 104
WEEK
Axes numbers 8 pts, Helvetica Neue

All Caps 9 pts Helvetica All Caps 9 pts Helvetica Neue
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Neue 57 light Condensed 57 light Condensed center
center vertically
Rule weight:.
All Caps 7 pts Helvetica Neue 01 point
47 light Condensed center
7 pts Helvetica Neue

47 light Condensed HUMIRA 40 mg EOWa + MTX (n=268)
The co-primary
endpoints were
FPO
Primary endpoints ACR50 response
799b,c patients MTX weekly (n=257) and change
in modified
total Sharp
score (mTSS)
HUMIRA 40 mg EOW (n=274) at Year 1 for
HUMIRA + MTX
vs MTX alone.
YEAR
0 1 2
a
EOW=every other week.
b
Intent-to-treat population.
Stable doses of concomitant NSAIDs and corticosteroids were permitted. Patients taking MTX escalated to 20 mg/wk by Week 8,
c Helvetica Neue LT Std
as needed/as tolerated. 67 Medium Condensed
9/10 pts
Helvetica Neue LT Std

47 Light Condensed
7/8 pts
19
Chart styles and details (continued)
All Caps 7 pts Helvetica Neue

77 Bold Condensed center
100 ACR50 100 ACR70

Legend:
NRI analysisa HUMIRA 40 mg EOW + MTX (n=268) 7 pts Helvetica Neue
80 MTX alone (n=257)
80 47 light Condensed
b
P<0.001.
Upper left corner
FPO
PATIENTS (%)
PATIENTS (%)
60 60
62%b 59%b
40 46% 40 46%b 47%b

43%
20 27% 28%
20
0 0 Rule weight:.
YEAR 1 YEAR 2 YEAR 1 YEAR 2 0.5 point
9 pts Helvetica Neue Numbers:8 pts Helvetica Neue

57 light Condensed 57 light Condensed
Table created in InDesign

Alternating row color scheme C0/M30/Y100/K025 % and 30%
Helvetica Neue
HUMIRA + MTX HUMIRA MTX 77 Bold Condensed
(n=268) (n=274) (n=257)
10 pts.
Age (yrs) 51.9 ± 14.0 52.1 ± 13.5 52.0 ± 13.1 HUMIRA PLUM
% female 72 77 74
% with prior disease-modifying
33 33 32
antirheumatic drugs (DMARDs) Helvetica Neue LT Std
FPO
% taking corticosteroids 36 37 35 47 Light Condensed
Years of RA 0.7 ± 0.8 0.7 ± 0.8 0.8 ± 0.9 9 pts
SJC (0-66) 21.1 ± 11.2 21.8 ± 10.5 22.1 ± 11.7
TJC (0-68) 30.7 ± 14.2 31.8 ± 13.6 32.3 ± 14.3
C-reactive protein, mg/dL 3.9 4.1 4.0
HAQ-DI 1.5 1.6 1.5
DAS28 6.3 6.4 6.3
mTSSb 18.1 ± 20.1 18.8 ± 19.0 21.9 ± 22.2
JE scoreb, 11.0 ± 12.3 11.3 ± 11.3 13.6 ± 13.6
Joint space narrowing (JSN) score b
7.1 ± 9.6 7.5 ± 9.4 8.2 ± 10.7
Estimated annual TSS progression 25.6 26.7 27.4

a
n=267 in the HUMIRA + MTX group, 271 in the HUMIRA monotherapy group, and 251 in the MTX monotherapy group.
b
P<0.05 among treatment arms.

c
Helvetica Neue LT Std

47 Light Condensed 7/6 pts
20
Slide Notes Layout Details

FPO
development of TB in patients who tested negative for latent TB infection prior to
initiating therapy.
MALIGNANCY
a EOW=every other week.

Patients taking MTX escalated to 20 mg/wk by Week 8, asneeded/as tolerated.
Patients 18 years old with a disease duration of <3 years were randomized to 1 of 3 treatment
groups: HUMIRA 40 mg subcutaneously every other week plus weekly oral methotrexate (MTX)
up to 20 mg/week; HUMIRA 40 mg subcutaneously every other week; or weekly oral MTX up to
20 mg/week.
• MTX was initiated at a dosage of 7.5 mg/week for the first 4 weeks. If the MTX
was well tolerated and the patient continued to have any swollen or tender joints,
the dosage could be escalated to 20 mg/week by week 8, as needed/as tolerated
• All patients received an injection (HUMIRA or placebo) and an oral medication
(MTX or placebo) safety area
for text
Study included a screening period, a 4-week washout period for patients taking other DMARDs
and a 2-year, blinded-treatment period.
799 MTX-naïve patients were enrolled in the study and 539 completed 2 years of treatment.
Reference:
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Reference Title: text: 11 points Arial Bold
space after 12 points Page numbers and Footer
11/12 pts Arial regulat
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• Safety area (pink dotted rule) 7.6528 x 6.7 (Nothing exceeds this area)
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eadlinesstart at edge of safety area, 24 points Arial Bold,Text box vertical alignment
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• Title slides Text: 36 points, 38 leading Flush left, Initial Caps, RGB = 214, 0, 87
• Codenumber (XXX-XXXXX) 8 pts, white, bottom left edge (inside red graphic) aligns with page
number
• lease see Abbott Representative for full Prescribing Information: 12 points, Arial Bold,
P
Black, Flush left. Sits anchored bottom left edge. Text box is set to “Bottom”
• File must not exceed 10 MB- ideal size is 5 MB
• Output must be in 2 formats for PMR:

• Microsoft PowerPoint 2003- locked with password (Abbott01) to not allow changes.
Printing, viewing, and forwarding is authorized.
• Adobe PDF (slideshow and speaker notes) for Macintosh users, locked with password
(Abbott01) to not allow changes. Printing, viewing and forwarding is authorized.
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Title with description text.................................................................................... 7

Slide picture on left........................................................................................... 8

Text without bullets......................................................................................... 10

ISI slide................................................................................................... 11-12

Slide with chart.. ........................................................................................ 13-15

Slide with table.............................................................................................. 16

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Abbott Sponsorship DisclosureAbbott Sponsorship Disclosure

Please see Important Safety Information, including BOXED WARNING on

Title slide Interior slides

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Important Safety Considerations (cont.)

SERIOUS INFECTIONS (continued)

Abbott Sponsorship Disclosure

• Hypersensitivity – Anaphylaxis or serious allergic reactions may occur.

HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories.

Please see Abbott Representative for full Prescribing Information.

36 Points. RGB-214,0,87 18 Points Arial italic

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Ankylosing Spondylitis (AS) Bullets: 115% size

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HUMIRA is indicated for reducing signs and symptoms, inducing major

HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories.

Text 100% Black 8 points./10 points. Page Number: 100% Black

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Important Safety Considerations

HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories.

Please see Abbott Representative for full Prescribing Information.

Please see Abbott Representative for full Prescribing Information.

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Bacterial, viral and other infections due to opportunistic pathogens.

SERIOUS INFECTIONS (continued) SERIOUS INFECTIONS (continued)

PREMIER 2-Year Study Design

FPO unify font

aEOW=every other week. bIntent-to-treat population.

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PREMIER: Mean Change From Baseline

a EOW=every other week.

Patients taking MTX escalated to 20 mg/wk by Week 8, asneeded/as tolerated.

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ACR50/70 Response Rates at Years 1 and 2 .5”

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Unless otherwise indicated, results are mean ± SD.

Breedveld FC et al. Arthritis Rheum. 2006;54:26-37

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