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UK PRESS RELEASE
Lancet publication: Visual II Study Shows Humira®(adalimumab) Lowers Risk of Uveitic
Flare by 43% in Patients with Inactive Non-Infectious Uveitis1 Requiring
Corticosteroids2

The Lancet-published study showed the risk of treatment failure for patients in the
adalimumab group was significantly reduced by 43% compared to patients in the placebo
group3
MAIDENHEAD, UK, August 17, 2016: AbbVie, a global biopharmaceutical company, today announced
that the Lancet has published the results of a new study, VISUAL II, demonstrating that treatment with
Humira (adalimumab) significantly lowers the risk of Uveitic Flare in Patients with Inactive Noninfectious Uveitis Requiring Corticosteroids (CS). VISUAL II found that in CS-dependent patients with
inactive, non-infectious uveitis, adalimumab significantly lowered the risk for uveitic flare or vision loss
upon prednisone taper.4 One of the key benefits of VISUAL II is that it is one of the first phase 3 trials of
a nonsteroidal systemic medication in inactive disease patients to show promise in treating inactive noninfectious uveitis in patients dependent on chronic oral CS to maintain disease inactivity.5
VISUAL II is a, phase 3, randomised, double-masked, placebo-controlled study conducted in 21 countries
involving 62 study sites between August 2010 and May 2015. The trial recruited 229 patients; of these
229 patients randomised to treatment, 226 were included in the intent-to-treat analyses. The risk of
treatment failure for patients in the adalimumab group was significantly reduced by 43% compared to
patients in the placebo group (HR, 0·57; 95% CI, 0·39–0·84; P=0·004).6 Adalimumab treated patients had
lower risk to fail and fewer criteria of treatment failure were met.7
In the VISUAL II study, adalimumab significantly reduced the risk of treatment failure (uveitic flare or
visual acuity loss), as demonstrated by an early and sustained separation of adalimumab and placebo
treatment failure curves.8 Adalimumab-treated patients had lower risk of failure and fewer criteria of
treatment failure were met.9
Dr Dolores M Conroy, Director of Research, Fight for Sight, said, “The publication of VISUAL II in the
Lancet is a step forward in understanding more about new treatment options for uveitis. For some,
current forms of treatment are not appropriate or do not offer relief. The development of new
treatments for uveitis was identified as a top priority by the Sight Loss and Vision Priority Setting
Partnership10 so we welcome the news that adalimumab could lower the risk of flares.”
Date of preparation – August 2016
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1
Uveitis is a group of inflammatory eye conditions which can be caused either by infection or abnormal
activation of the immune system in the uvea, the middle part of the eye.11,12 Uveitis is one of the leading
causes of visual impairment and is responsible for 10-15% of blindness in western countries13; 91% of
patients with uveitis are diagnosed with non-infectious etiology.14
Corticosteroids (CS) have been the mainstay of uveitis approval of a variation treatment, but ocular
and/or systemic adverse effects limit their long-term use in the treatment of intermediate, posterior, or
panuveitis.15,16 There are few currently approved non-CS immunomodulatory agents for uveitis
worldwide that can provide long-term control of uveitis.17,18 Globally, there is an unmet need that
warrants pursuit of additional effective therapies in steroid-dependent patients with non-infectious
uveitis who are at risk for long-term CS side effects.
Humira® (adalimumab) last month received approval of a variation from the European Medicines
Agency (EMA), making it the first and only biologic medicine authorised for patients with certain types
of non-infectious uveitis that can severely impact vision, and can lead to blindness. Adalimumab is now
authorised in the EU, as a treatment option for uveitis affecting the middle, back or multiple parts of the
eye, called the uvea, and can be used in adults for whom typical treatment with corticosteroids is
insufficient in controlling the inflammation, or where that treatment has started to cause
complications.19
VISUAL II found no new safety risks, with all adverse events being consistent with adalimumab’s
established safety profile.20
###
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation
from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique
approach to innovation to develop and market advanced therapies that address some of the world’s
most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie
employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and commitments, please visit
www.abbvie.co.uk
About Humira (adalimumab):
For further information, please see the Summary of Product Characteristics:
http://www.medicines.org.uk/emc/medicine/21201.
UK Media Contacts:
Maeve McCormack
Senior Consultant
Luther Pendragon
020 7618 9100
[email protected]
Sarah Jones
Senior Patient Relations and Brand
Communications Manager, Rheumatology,
AbbVie UK
073411 01900
[email protected]
2
References
1
Intermediate, posterior and panuveitis
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
2016 (accessed 17 August 2016); 5.
3
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
2016 (accessed 17 August 2016); 5.
4
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
2016 (accessed 17 August 2016); 5.
5
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
2016 (accessed 17 August 2016); 8.
6
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
2016 (accessed 17 August 2016); 5.
7
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
2016 (accessed 17 August 2016); 5.
8
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
2016 (accessed 17 August 2016); 8.
9
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
2016 (accessed 17 August 2016); 5.
10
Rowe F, Wormald R, Cable R, Acton M, Bonstein K, et al., The Sight Loss and Vision Priority Setting Partnership
(SLV-PSP): overview and results of the research prioritisation survey process. BMJ Open. 2014 Jul 23;4(7.)
2
11
Jabs, D.A., et al. Standardization of Uveitis Nomenclature for Reporting Clinical Data. Results of the First International
Workshop. J Ophthalmol 2005; 140 (3): 509-516
12
Guly, C.M. and Forrester, J.V., et al. Investigation and Management of Uveitis. BMJ 2010; 341: 821-826.
13
Nussenblatt RB. The natural history of uveitis. International ophthalmology. 1990; 14:303–8.
Wakefield D, Chang JH. Epidemiology of uveitis. International ophthalmology clinics. 2005; 45:1–13.
15
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
2016 (accessed 17 August 2016); 1.
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Jabs DA, Rosenbaum JT, Foster CS, et al. Guidelines for the use of immunosuppressive drugs in patients with
ocular inflammatory disorders: recommendations of an expert panel.American journal of ophthalmology 2000;
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Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
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3
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
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18
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
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19
European Commission, http://ec.europa.eu/health/documents/community-register/html/h256.htm#top
Accessed August 8, 2016
20
Quan Dong Dong Nguyen, MD, MSc, MD, MSc. Adalimumab for the Prevention of Uveitic Flare in Patients with
Inactive Non-infectious Uveitis Requiring Corticosteroids: A Multicenter, Double-masked, Placebo-Controlled Phase
3, Randomised Controlled Trial. The Lancet published online http://dx.doi.org/10.1016/S0140-6736(16)31339-3 1
2016 (accessed 17 August 2016); 7.
4