Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® (baricitinib): Användning hos patienter med atopisk dermatit och redan befintlig tuberkulos

Baricitinibs effekt och säkerhet har inte utvärderats hos patienter med måttlig till svår atopisk dermatit och redan existerande tuberkulos.

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SE_cFAQ_BAR085B_HISTORY_TB_AD
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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

Exclusion Criteria Related to Tuberculosis Infection

Patients were excluded from enrollment in the phase 3 BREEZE-AD studies if they had a current or recent clinically serious viral, bacterial, fungal, or parasitic infection, including

  • evidence of active TB at screening defined as
    • positive PPD test
    • medical history
    • clinical features, and
    • abnormal chest x-ray
  • evidence of untreated or inadequately treated latent TB defined as
    • documented positive PPD test
    • no clinical features or medical history consistent with active TB, and
    • a chest x-ray with no evidence of active TB at screening.
  • previous evidence of active TB with no appropriate and documented treatment received
  • household contact with a person with active TB with no appropriate and documented prophylaxis for TB received, or
  • any active or recent infection within 4 weeks of randomization that, in the opinion of the investigator, would have posed as an unacceptable risk to the patient if participating in the study.5

QuantiFERON®-TB Gold test or T-SPOT® TB test (as available and if compliant with local TB guidelines) were allowed to be used instead of the PPD test.5

Inclusion Criteria Related to Tuberculosis Infection

Patients with a history of active or latent TB could participate in the BREEZE-AD studies if all other entry criteria were met and they had

  • documented evidence of appropriate treatment for TB
  • no history of re-exposure since their treatment was completed, and
  • a chest x-ray with no evidence of active TB at screening.5

These patients were not required to undergo the protocol-specific TB testing for PPD, QuantiFERON®-TB Gold test, or T-SPOT® TB test.5

Patients with evidence of latent TB could participate in the BREEZE-AD studies if they

  • completed at least 4 weeks of appropriate treatment prior to randomization, and
  • agreed to complete the remainder of treatment while in the trial.5

In the BREEZE-AD trials, investigators were to follow local guidelines to monitoring patients for TB if a patient were at a high risk of acquiring TB or reactivation of latent TB.5

Patients With Atopic Dermatitis and Preexisting Tuberculosis

An analysis of the efficacy and safety of BARI in patients with moderate to severe AD and preexisting TB infection has not been conducted.

The numbers of patients in the pivotal phase 3 BREEZE-AD trials with moderate to severe AD and a preexisting TB are presented in Summary of Patients With Preexisting TB in the Pivotal Phase 3 BREEZE-AD Trials (ITT Population).

Summary of Patients With Preexisting TB in the Pivotal Phase 3 BREEZE-AD Trials (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)

Latent TB, n (%)

1 (0.4)

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)

Latent TB, n (%)

2 (0.8)

1 (0.8)

0

1 (0.8)

Mycobacterium TB complex test positive, n (%)

0

0

1 (0.8)

0

BREEZE-AD5
(N=440)

Placebo
(N=147)

BARI 1 mg
(N=147)

BARI 2 mg
(N=146)

NA

Latent TB, n (%)

1 (0.7)

1 (0.7)

1 (0.7)

NA

Combination Studies


BREEZE-AD4
(N=463)

Placebo
(N=93)

BARI 1 mg
(N=93)

BARI 2 mg
(N=185)

BARI 4 mg
(N=92)

Latent TB, n (%)

0

 0

1 (0.5) 

 0

Mycobacterium TB complex test positive, n (%)

1 (1.1)

0

0

0

BREEZE-AD7
(N=329)

Placebo
(N=109)

NA

BARI 2 mg
(N=109)

BARI 4 mg
(N=111)

Latent TB, n (%)

1 (0.9)

NA

1 (0.9)

1 (0.9)

TB, n (%)

1 (0.9)

NA

0

0

Abbreviations: AD = atopic dermatitis; BARI = baricitinib; ITT = intent-to-treat; NA = not applicable; TB = tuberculosis.

Warnings and Precautions Related to Tuberculosis

Patients should be screened for tuberculosis (TB) before starting baricitinib therapy.6

  • Baricitinib should not be given to patients with active TB.6
  • Anti-TB therapy should be considered prior to initiation of Baricitinib in patients with previously untreated latent TB.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

PPD = purified protein derivative

TB = tuberculosis

TCS = topical corticosteroids

Datum fӧr senaste ӧversyn 2020 M06 23


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