4 From Patient Value Strategy to action in immunology

  • Bringing Cimzia® to more than 123 000 patients living with rheumatoid arthritis, psoriasis, psoriatic arthritis, axial spondyloarthritis and Crohn’s disease
  • Based on patient’s input, UCB developed a pre-filled syringe, an autoinjector (AutoClicks®), and an e-device (Ava®) for Cimzia®
  • Women of child bearing age living with chronic inflammatory diseases
  • Patients living with psoriasis expect more
  • 4 out of 10 patients living with psoriasis will develop psoriatic arthritis6
  • First clinical studies demonstrating minimal transfer of Cimzia® through the placenta (CRIB) and breast milk (CRADLE)
  • bimekizumab: translating scientific hypotheses into clinical differentiation

Patients want more and deserve more

Grace, living with PsO & PsA

There are many patients suffering from chronic inflammatory diseases such as rheumatoid arthritis, psoriasis, psoriatic arthritis and axial spondyloarthritis. For women with chronic inflammatory disease, the prospect of having children brings many questions about health and medicines. 

Women frequently discontinue their treatment before and throughout pregnancy, a time when disease control is essential to ensure optimal infant and maternal health, or reluctantly postpone conception. The consequences of active disease in pregnancy can have serious implications for both mother and infant, including an increased risk of miscarriage7, an increased risk of preterm delivery, the need for a caesarean, and the infant being small for gestational age8. These women are faced with difficult questions regarding the impact of active disease flares on themselves and their babies and need more information on therapeutic intervention9.

UCB has been leading the way in studying how biologic drugs impact women of childbearing age, conducting two first-of-their-kind studies, CRIB10 (to evaluate the placental transfer mother-foetus) and CRADLE11 (to evaluate the transfer to breast milk). Results demonstrated minimal transfer of Cimzia® through placenta or through the breast milk. CRIB and CRADLE data led to a label update in 2018, helping women and their treating physicians to make informed decisions to manage their condition along their pregnancy journey.

Because of its visible and physically debilitating aspects, psoriasis often takes an emotional toll on patients, causing increased self-consciousness, frustration, fatigue, depression, and even suicidal ideation12. Thanks to innovation, new treatment options have been developed and are available to patients. This broader choice of therapeutics also led to higher expectations among patients. Less plaque is not enough anymore, they want a clear skin10, they want all physical, emotional and social signs of the disease to disappear!

UCB is developing bimekizumab. Our scientific hypothesis: by targeting inflammation associated with psoriasis on two fronts, neutralizing IL-17A and IL-17F cytokines, bimekizumab has the potential to raise the bar for achieving and maintaining skin clearance rates. Phase 2b results showed that up to 60% treated with bimekizumab rapidly achieved completely clear skin. Based on the fast and significant results, UCB rapidly advanced to Phase 3 clinical development program, with results expected in Q4 2019.

Here are the major milestones we reached or plan to reach:

Grow & Prepare
(2015-2018)

Cimzia® (certolizumab pegol)
  • approval in psoriasis (U.S. & EU – 2018)
  • women of child bearing age label update 
    (U.S., EU & Japan – 2018)
  • filing in non-radiographic axial spondyloarthritis (U.S. – 2018)
  • filing in rheumatoid arthritis
    (China - 2018)
  • Phase 3 study in psoriasis & psoriatic arthritis (Japan - 2018)
  • CRIB study (2017)
  • CRADLE study (2016)
  • EXXELERATE study (2016)
  • AutoClicks® and ava® devices
bimekizumab

Accelerate & Expand
(2019-2021)

Cimzia® (certolizumab pegol)
  • filing in psoriasis & psoriatic arthritis (Japan – Jan 2019)
  • regulatory decision in non-radiographic axial spondylo­arthritis (U.S. – Q2 2019)
  • regulatory decision in rheumatoid arthritis (China)
bimekizumab
  • Phase 3 to start in psoriatic arthritis (Q2 2019)
  • Phase 3 to start in axial spondyloarthritis (Q2 2019)
  • Phase 3 results in psoriasis (Q4 2019)

Breakthrough & Lead
(2022-2025)

Cimzia® (certolizumab pegol)
  • patent expiry (U.S. & EU – 2024)
  • loss of exclusivity (Japan – 2026)

Please refer to UCB website for more information about Cimzia® approved indications.

6 Mease PJ and Armstrong AW. Managing Patients with Psoriatic Disease: The Diagnosis and Pharmacologic Treatment of Psoriatic Arthritis in Patients with Psoriasis. Drugs. 2014;74(4):423-41. Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64 Suppl 2:ii14-7.

7 Brouwer J, Laven JS, Hazes JM, Dolhain RJ. Miscarriages in Female Rheumatoid Arthritis Patients: Associations with Serologic Findings, Disease Activity, and Antirheumatic Drug Treatment. Arthritis Rheumatol. 2015;67(7):1738–43.

8 Bharti B, Lee SJ, Linday SP, et al. Disease severity and pregnancy outcomes in women with rheumatoid arthritis: results from the Organization of Teratology Information Specialists autoimmune diseases in pregnancy project. J Rheumatol. 2015;42:1376–1382

9 Brouwer J, Hazes JMW, Laven JSE, et al. Fertility in Women with Rheumatoid Arthritis: Influence of Disease Activity and Medication. Annals of the Rheumatic Diseases 2015;74:1836-1841.

10 Abraham B, Mariette X, Flynn AD, et al. Lack of Placental Transfer of Certolizumab Pegol During Pregnancy: Results from CRIB, a Prospective, Postmarketing, Multicenter, Pharmacokinetic Study. Gastroenterol. 2017;S0016-5085(17)34376–7.

11 Clowse ME, Förger F, Hawng C, et al. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017;0:1–7.

12 International Federation of Psoriasis Associations – Accessed 4 February 2019

Nikolas, living with rheumatoid arthritis