Olumiant ® ▼ (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Olumiant Summary of Product Characteristics (SmPC)

Olumiant®▼ (baricitinib): Use in Patients With Atopic Dermatitis and Preexisting Venous Thromboembolic Event

The efficacy and safety of baricitinib in patients with moderate to severe atopic dermatitis and a preexisting condition of VTE have not been studied.

UK_cFAQ_BAR083B_PREEXISTING_VENOUS THROMBOEMBOLIC EVENT_AD
UK_cFAQ_BAR083B_PREEXISTING_VENOUS THROMBOEMBOLIC EVENT_AD
en-GB

Overview of BREEZE-AD Phase 3 Placebo-Controlled Clinical Trials 

The efficacy and safety of BARI has been evaluated in the following placebo-controlled trials in adult patients with moderate to severe AD

  • BREEZE-AD1 (N=624) and BREEZE-AD2 (N=615) compared BARI 1 mg, 2 mg, or 4 mg monotherapy to placebo in adult patients with inadequate response to TCS.1
  • BREEZE-AD4 (N=500) compared BARI 1 mg, 2 mg, or 4 mg in combination with TCS vs placebo with TCS in adult patients who were inadequate responders to, intolerant of, or contraindicated for cyclosporine.2
  • BREEZE-AD5 (N=440) compared BARI 1 mg or 2 mg monotherapy to placebo in adult patients with inadequate response to TCS.3
  • BREEZE-AD7 (N=329) compared BARI 2 mg or 4 mg in combination with TCS vs placebo with TCS in adult patients with inadequate response to topical medications.4

Note: BARI 1 mg was studied in pivotal trials, however it is not approved. Please refer to section 4.2 of the Olumiant Summary of Product Characteristics for approved dosage.

BREEZE-AD Clinical Trial Criteria

Patients were excluded from enrollment in the BREEZE-AD1, BREEZE-AD2, BREEZE-AD4, and BREEZE-AD7 studies if they had

  • experienced a VTE event (DVT or PE) within 12 weeks of screening, or 
  • a history of recurrent (≥2) VTE or were considered at high risk of VTE as deemed by the investigator.5

Patients were excluded from enrollment in the BREEZE-AD5 study if they

  • had a history of VTE
  • were considered at high risk for VTE as deemed by the investigator, or
  • had ≥2 risk factors for VTE including
    • aged >65 years
    • BMI >35 kg/m2, and
    • oral contraceptive use and current smoker.5

Patients With Atopic Dermatitis and a Preexisting Condition of Venous Thromboembolic Event

An analysis of the efficacy and safety of BARI in patients with moderate to severe AD and a preexisting VTE, including DVTs and PEs, has not been conducted.

The numbers of patients in the pivotal phase 3 trials BREEZE-AD1, BREEZE-AD2, and BREEZE-AD5 with moderate to severe AD and a preexisting VTE are presented in Summary of Patients With a Preexisting Condition of VTE, including DVTs and PEs, in the Pivotal Phase 3 Trials BREEZE-AD1, BREEZE-AD2, and BREEZE-AD5 (ITT Population)  . No patients reported a preexisting VTE in the BREEZE-AD4 and BREEZE-AD7 studies.5

Summary of Patients With a Preexisting Condition of VTE, including DVTs and PEs, in the Pivotal Phase 3 Trials BREEZE-AD1, BREEZE-AD2, and BREEZE-AD5 (ITT Population)5  

Monotherapy Studies





BREEZE-AD1
(N=624)

Placebo
(N=249)

BARI 1 mg
(N=127)

BARI 2 mg
(N=123)

BARI 4 mg
(N=125)

Intracranial venous sinus thrombosis, n (%)

0

0

1 (0.8)

0

BREEZE-AD2
(N=615)

Placebo
(N=244)

BARI 1 mg
(N=125)

BARI 2 mg
(N=123)

BARI 4 mg
(N=123)

Thrombophlebitis superficial, n (%)

1 (0.4)

0

0

0

BREEZE-AD5
(N=440)

Placebo
(N=147)

BARI 1 mg
(N=147)

BARI 2 mg
(N=146)

NA

Post thrombotic syndrome, n (%)

0

1 (0.7)

0

NA

Abbreviations: AD = atopic dermatitis; BARI = baricitinib; DVT = deep vein thrombosis; ITT = intent-to-treat; NA = not applicable; PE = pulmonary embolism; VTE = venous thromboembolism.

Warnings and Precautions Related to Venous Thromboembolism

Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib.6

Baricitinib should be used with caution in patients with risk factors for DVT/PE, such as

  • older age,
  • obesity,
  • a medical history of DVT/PE, or
  • patients undergoing surgery and immobilisation.6

If clinical features of DVT/PE occur, baricitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.6

References

1Simpson EL, Lacour JP, Spelman L, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. Br J Dermatol. 2020;183(2):242-255. http://dx.doi.org/10.1111/bjd.18898

2A long-term study of baricitinib (LY3009104) with topical corticosteroids in adults with moderate to severe atopic dermatitis that are not controlled with cyclosporine or for those who cannot take oral cyclosporine because it is not medically advisable (BREEZE-AD4). ClinicalTrials.gov identifier: NCT03428100. Updated January 3, 2020. Accessed September 16, 2020. https://clinicaltrials.gov/ct2/show/NCT03428100

3Simpson E, Forman S, Silverberg J, et al. Efficacy and safety of baricitinib in moderate-to-severe atopic dermatitis: results from a randomized, double-blinded, placebo-controlled phase 3 clinical trial (BREEZE-AD5). Abstract presented at: Revolutionizing Atopic Dermatitis (RAD) Virtual Symposium; April 5, 2020. Accessed April 5, 2020.

4Reich K, Kabashima K, Peris K, et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in moderate to severe atopic dermatitis: results of a phase 3 randomized, double-blind, placebo-controlled 16-week trial (BREEZE-AD7). Abstract presented at: European Academy of Dermatology and Venereology 28th Congress; October 9-13, 2019; Madrid, Spain.

5Data on file, Eli Lilly and Company and/or one of its subsidiaries.

6Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

AD = atopic dermatitis

BARI = baricitinib

BMI = body mass index

DVT = deep vein thrombosis

PE = pulmonary embolism

TCS = topical corticosteroids

VTE = venous thromboembolism

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: June 23, 2020


Contact Lilly

Call or Email us

If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com

Available Mon - Fri, 10am - 4pm, excluding Bank Holidays

Or you can

Chat with Us

Click to Chat is Offline

If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a request