Olumiant ® (baricitinib) tabletter

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Olumiant® (baricitinib): Atopisk dermatit fas 3 -studier

Effekten ochsäkerhet av baricitinib utvärderas i fas 3 -studier av atopisk dermatit. Studiebeskrivningar av fas 3 -programmet för baricitinib för atopisk dermatit tillhandahålls.

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Atopic Dermatitis Phase 3 Clinical Trial Program

The efficacy and safety of BARI is being evaluated in phase 3 AD studies including

The BREEZE-AD1, BREEZE-AD2, BREEZE-AD3, BREEZE-AD7, and BREEZE-AD-PEDS studies' primary efficacy outcome is the proportion of patients achieving a response of 0 or 1 with a ≥ 2-point improvement on the Investigator’s Global Assessment in the BARI dose group compared with placebo at week 16.1-4,8-11

The BREEZE-AD4, BREEZE-AD5, and BREEZE-AD6 studies' primary efficacy outcome is the proportion of patients achieving EASI 75 in the BARI dose group compared with placebo at week 16.5-8

BREEZE-AD phase 3 program study design details including secondary outcome measures are described in Atopic Dermatitis Phase 3 Studies in the Baricitinib Clinical Program.

Atopic Dermatitis Phase 3 Studies in the Baricitinib Clinical Program1-13

Monotherapy Clinical Trials

Combination with TCS Clinical Trials

Long Term Extension

Pediatric

 

Study BREEZE-AD1 and BREEZE-AD2

Study BREEZE-AD5

Study BREEZE-AD4

Study BREEZE-AD7

Study BREEZE-AD3

Study BREEZE-AD6

Study BREEZE-AD-PEDS

Design summary

Randomized, double-blind, placebo controlled, and parallel assignment, 16-week duration

Randomized, double-blind, placebo controlled, and parallel assignment, 16-week duration, then patients may enroll in LTE, BREEZE-AD6

Randomized, double-blind, placebo controlled, and parallel assignment, long-term study

Randomized, double-blind, placebo controlled, and parallel assignment, 16-week duration

Randomized, double-blind, placebo controlled, and parallel assignment, LTE of patients from BREEZE-AD1, BREEZE-AD2, and BREEZE-AD7

Open-label, long-term study of patients from BREEZE-AD5

Open-label 2-week PK study followed by randomized, double-blind, placebo controlled, and parallel assignment, outpatient 16-week duration followed by 2-year long-term study

Estimated enrollment

600 adult patients

450 adult patients

500 adult patients

300 adult patients

1760 adult patients

300 adult patients

465 children and teen patients

Final enrollment

1239 adult patients

440 adult patients

463 adult patients

329 adult patients

ongoing

ongoing

recruiting

Treatment arms

BARI 4 mg,
BARI 2 mg,
BARI 1 mg, or
Placebo

BARI 2 mg,
BARI 1 mg, or
Placebo

BARI 4 mg +TCS,
BARI 2 mg + TCS,
BARI 1 mg+TCS,
placebo +TCS

BARI 4 mg +TCS,
BARI 2 mg +TCS,
placebo +TCS

BARI 4 mg,
BARI 2 mg,
BARI 1 mg, or
Placebo

Open-label extension

BARI

BARI open-label high-dose during 2-week PK lead-in

High-dose BARI +TCS, mid-dose BARI +TCS, low-dose BARI +TCS, and matched placebo +TCS

Primary outcome measure

Investigator’s Global Assessment

EASI 75

EASI 75

Investigator’s Global Assessment

Investigator’s Global Assessment

EASI 75

PK: AUC and Cmax of BARI

Investigator’s Global Assessment

Additional secondary outcome measures

EASI, itch NRS, skin pain NRS, SCORAD, BSA affected, skin infections requiring antibiotic treatment, POEM, HADS, DLQI, WPAI-AD, EQ-5D-5L, item 2 of ADSS, and PGI-S-AD

IGA, EASI, itch NRS, skin pain NRS, SCORAD, BSA affected, skin infections requiring antibiotic treatment, POEM, HADS, DLQI, WPAI-AD, EQ-5D-5L, item 2 of ADSS, and PGI-S-AD

IGA, EASI, itch NRS, skin pain NRS, SCORAD, BSA affected, skin infections requiring antibiotic treatment, POEM, HADS, DLQI, WPAI-AD, EQ-5D-5L, item 2 of ADSS, and PGI-S-AD, TCS use

EASI, itch NRS, skin pain NRS, SCORAD, BSA affected, skin infections requiring antibiotic treatment, POEM, HADS, DLQI, WPAI-AD, EQ-5D-5L, item 2 of ADSS, and PGI-S-AD, TCS use

EASI and itch NRS

IGA, EASI, itch NRS, BSA affected

Palatability (taste and smell) and Acceptability of BARI (during 2-week lead-in)

EASI, itch NRS, skin pain NRS, SCORAD, BSA affected, skin infections requiring antibiotic treatment, mean days without TCS [use], TCS tube weights, PGI-S-AD, POEM, PRISM, PROMIS-anxiety, PROMIS-depression, EQ-5D-Y, DFI, CDLQI/IDQOL, WPAI-AD-CG, item 2 of ADSS for patients ≥10 years old, change of IgG Titers at week 12, height/growth rate long-term

Abbreviations: AD = atopic dermatitis; ADSS = Atopic Dermatitis Sleep Scale; AUC = area under the concentration-time curve; BARI = baricitinib; BSA = body surface area; Cmax = maximum concentration; CDLQI = Children’s Dermatology Life Quality Index; DFI = Dermatitis Family Impact; DLQI = Dermatology Life Quality Index; EASI = Eczema Area and Severity Index; EASI 75 = Eczema Area and Severity Index 75% improvement; EQ-5D-5L = European Quality of Life – 5 Dimensions 5 Levels; EQ-5D-Y = European Quality of Life-5 Dimensions-Youth version; HADS = Hospital Anxiety Depression Scale; IDQOL = Infant’s Dermatitis Quality of Life Index; IGA = Investigator’s Global Assessment; IgG = Immunoglobulin G; LTE = long-term extension; NRS = numeric rating scale; PGI-S-AD = Patient Global Impression of Severity – Atopic Dermatitis; PK = pharmacokinetics; POEM = Patient Oriented Eczema Measure; SCORAD = SCORing Atopic Dermatitis; PRISM = Parent-Reported Itch Severity Measure; PROMIS = Patient-Reported Outcomes Measurement Information System; TCS = topical corticosteroids; WPAI-AD = Work Productivity and Activity Impairment – Atopic Dermatitis; WPAI-AD-CG = Work Productivity and Activity Impairment Questionnaire: Atopic Dermatitis Caregiver.

Updated information on initiation, recruitment, and enrollment in these and other relevant studies will be made available on www.ClinicalTrials.gov.

BREEZE-AD Phase 3 Program Study Details

Monotherapy Studies

BREEZE-AD1, BREEZE-AD2, and BREEZE-AD5 are monotherapy studies.1-3,5,8

Patients enrolled in these monotherapy studies have moderate-to-severe AD and have inadequate response to topical medications.1-3,5,8

Patients who complete the 16-week, randomized, double-blind, placebo-controlled studies, BREEZE-AD1 and BREEZE-AD2 may enroll into the 52-week BREEZE-AD3 extension study.1-4

BREEZE-AD5 eligible patients may enroll into the 116-week BREEZE-AD6 open-label extension study.5,6

Inclusion Criteria

The inclusion requirements for patients in the BREEZE-AD1, BREEZE-AD2, BREEZE-AD3, BREEZE-AD5, and BREEZE-AD6 are as follows

  • ≥18 years old
  • a diagnosis of moderate-to-severe AD for at least 12 months
  • inadequate response or intolerance to existing topical medications within 6 months before screening
  • agreement to discontinue treatments for eczema such as systemic and topical treatments during a washout period, and
  • agreement to use emollients daily.1-6,8

Topical Corticosteroids Combination Study

The 16-week study, BREEZE-AD7 (NCT03733301), evaluates the efficacy and safety of BARI in combination with topical corticosteroids in patients with moderate to severe AD.9,11

Patients who complete the 16-week, randomized, double-blind, placebo-controlled study, BREEZE-AD7 may enroll into the 52-week BREEZE-AD3 extension study.4,11

Inclusion Criteria

The inclusion requirements for patients in the BREEZE-AD7 study are as follows

  • ≥18 years old
  • a diagnosis of moderate-to-severe AD for at least 12 months
  • inadequate response or intolerance to existing topical medications within 6 months before screening
  • agreement to discontinue treatments for eczema such as systemic and topical treatments during a washout period, and
  • agreement to use emollients daily.9,11

Cyclosporine Inadequate Responder Study

The long-term study, BREEZE-AD4 (NCT03428100), evaluates the efficacy and safety of BARI in combination with topical corticosteroids in patients who have had an inadequate response, intolerance, or contraindication to cyclosporine.7

Inclusion Criteria

The inclusion requirements for patients in the BREEZE-AD4 are as follows

  • ≥18 years old
  • a diagnosis of moderate-to-severe AD for at least 12 months
  • inadequate response or intolerance to existing topical medications within 6 months before screening
  • agreement to discontinue treatments for eczema such as systemic and topical treatments during a washout period
  • agreement to use emollients daily, and
  • have a medical contraindication to cyclosporine, or had intolerance and/or unacceptable toxicity or inadequate response to cyclosporine in the past.7

Extension Studies

Patients who complete BREEZE-AD1, BREEZE-AD2, and BREEZE-AD7 may enroll into the 52-week BREEZE-AD3 extension study.1,2,4,11

Patients who complete BREEZE-AD5 may enroll into the 116-week BREEZE-AD6 open-label extension study.5,6

Baricitinib Indication for Atopic Dermatitis

Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.14

The pivotal phase 3 studies related to the approved indication are:  BREEZE-AD1, BREEZE-AD2, BREEZE-AD7 and BREEZE-AD4. For further information please refer to the Olumiant Summary of Product Characteristics.

References

1A study of baricitinib (LY3009104) in adults with moderate to severe atopic dermatitis (BREEZE-AD1). ClinicalTrials.gov identifier: NCT03334396. Updated January 18, 2020. Accessed February 4, 2020. https://clinicaltrials.gov/ct2/show/NCT03334396

2Study of baricitinib (LY3009104) in adults with moderate to severe atopic dermatitis (BREEZE-AD2). ClinicalTrials.gov identifier: NCT03334422. Updated January 22, 2020. Accessed February 4, 2020. https://clinicaltrials.gov/ct2/show/NCT03334422

3Simpson 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

4A study of long-term baricitinib (LY3009104) therapy in atopic dermatitis (BREEZE-AD3). ClinicalTrials.gov identifier: NCT03334435. Updated March 17, 2020. Accessed September 9, 2019. https://clinicaltrials.gov/ct2/show/NCT03334435

5A study of baricitinib (LY3009104) in adult participants with moderate to severe atopic dermatitis (BREEZE-AD5). ClinicalTrials.gov identifier: NCT03435081. Updated January 3, 2020. Accessed January 3, 2020. https://clinicaltrials.gov/ct2/show/NCT03435081

6A 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

7A 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

8Simpson 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.

9Reich 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.

10A study of baricitinib (LY3009104) in children and adolescents with atopic dermatitis (BREEZE-AD-PEDS). ClinicalTrials.gov identifier: NCT03952559. Updated October 19, 2020. Accessed October 19, 2020. https://clinicaltrials.gov/ct2/show/NCT03952559

11A study of baricitinib (LY3009104) in combination with topical corticosteroids in adults with moderate to severe atopic dermatitis (BREEZE-AD7). ClinicalTrials.gov identifier: NCT03733301. Updated September 23, 2019. Accessed October 10, 2019. https://clinicaltrials.gov/ct2/show/NCT03733301

12A phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of baricitinib in combination with topical corticosteroids in adult patients with moderate-to-severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to, cyclosporine. ClinicalTrialsRegister.eu identifier: EudraCT 2017-004574-34/GB. Posted March 29, 2018. Accessed April 13, 2020. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-004574-34/GB

13A phase 3 multicenter, double-blind study to evaluate the long-term safety and efficacy of baricitinib in adult patients with atopic dermatitis. EudraCT Identifier: 2017-000873-35/CZ. Posted September 22, 2017. Accessed April 27, 2020. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-000873-35/CZ

14Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

AD = atopic dermatitis

BARI = baricitinib

EASI 75 = Eczema Area and Severity Index 75% improvement

PK = pharmacokinetic

Datum fӧr senaste ӧversyn 2020 M05 01


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