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Olumiant ® (baricitinib) tabletter
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
Hur man växlar mellan Olumiant® (baricitinib) och biologiska behandlingar för atopisk dermatit?
Det kliniska programmet BREEZE-AD utvärderade inte effekten och säkerheten av att byta patient till och från en biologisk behandling för atopisk dermatit till baricitinib.
Atopic Dermatitis Clinical Trials
Baricitinib may be used as monotherapy or in combination with topical corticosteroids. Topical calcineurin inhibitors may be used. Combination with biologic immunomodulators, other JAK inhibitors, cyclosporine, or other potent immunosuppressants has not been studied in patients with atopic dermatitis and is not recommended.1
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.2
- 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.3
- BREEZE-AD5 (N=440) compared BARI 1 mg or 2 mg monotherapy to placebo in adult patients with inadequate response to TCS.4
- 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.5
In addition, adult patients from the placebo-controlled trials were eligible for enrollment in the following long-term extension studies
- BREEZE-AD3 (estimated enrollment N=1760) a 104-week double-blind extension study in responders or non-responders who completed BREEZE-AD1, BREEZE-AD2 and BREEZE-AD7.
- Non-responders in the originating study were randomized to a BARI 2 mg, or BARI 4 mg.
- Responders remained on the assigned treatments from the originating study.
- At week 52, all adult patients were eligible for a down-titration or withdrawal sub-study.6
- BREEZE-AD6 (estimated enrollment N=300) a 204-week open-label extension study for nonresponders from BREEZE-AD5 who were discontinued from the trial at week 16.7
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.
Switching From a Biologic Atopic Dermatitis Treatment to Baricitinib in the BREEZE-AD Clinical Program
The BREEZE-AD clinical program did not prospectively assess the efficacy and safety of switching patients from a biologic therapy for AD to BARI.1
Prior to randomization in the placebo-controlled BREEZE-AD studies, patients receiving biologic treatments for AD were washed out for 5 half-lives to avoid any interference with the study drug.1
Switching From Baricitinib to a Biologic Treatment for Atopic Dermatitis in the BREEZE-AD Clinical Program
The BREEZE-AD clinical program did not prospectively assess the efficacy and safety of switching patients from BARI to a biologic treatment for AD.1
Rescue With Biologic Treatments for Atopic Dermatitis in the BREEZE-AD Clinical Trial Program
The majority of placebo-controlled BREEZE studies prohibited the use of biologic therapies resulting in permanent discontinuation from the study (see ).1
In BREEZE-AD4, patients whose disease could not be controlled by high potency TCS, ultra-high potency TCS, or phototherapy could have been rescued to biologic treatment for AD, which led to permanent discontinuation (see ).1
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Simpson 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
3A 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
4Simpson 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). Talk presented at: Revolutionizing Atopic Dermatitis (RAD) Virtual Symposium; April 5, 2020. Accessed April 5, 2020.
5Reich 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). Talk presented at: European Academy of Dermatology 28th Congress; October 9-13, 2019; Madrid, Spain.
6A study of long-term baricitinib (LY3009104) therapy in atopic dermatitis (BREEZE-AD3). ClinicalTrials.gov identifier: NCT03334435. Updated March 17, 2020. Accessed September 16, 2020. https://clinicaltrials.gov/ct2/show/NCT03334435
7A study of baricitinib (LY3009104) in participants with moderate to severe atopic dermatitis (BREEZE-AD6). ClinicalTrials.gov identifier: NCT03559270. Updated September 4, 2020. Accessed September 16, 2020. https://clinicaltrials.gov/ct2/show/NCT03559270
AD = atopic dermatitis
BARI = baricitinib
JAK = Janus kinase
TCS = topical corticosteroids
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