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Olumiant ® (baricitinib)
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Olumiant® (baricitinib): What is the efficacy and safety in patients with atopic dermatitis and pre-existing tuberculosis?
The efficacy and safety of baricitinib have not been assessed in patients with moderate to severe atopic dermatitis and preexisting tuberculosis.
Warnings and Precautions Related to Tuberculosis
Patients should be screened for tuberculosis (TB) before starting therapy.1
Serious and sometimes fatal infections have been reported in patients receiving other JAK inhibitors.1
Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo. In rheumatoid arthritis clinical studies, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.1
The risks and benefits of treatment should be carefully considered prior to initiating baricitinib in patients with active, chronic or recurrent infections.1
If an infection develops, the patient should be monitored carefully and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Treatment should not be resumed until the infection resolves.1
As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients over 65 years of age, baricitinib should only be used if no suitable treatment alternatives are available.1
Overview of BREEZE-AD Phase 3 Placebo-Controlled Clinical Trials
The efficacy and safety of baricitinib has been evaluated in the following placebo-controlled trials in adult patients with moderate to severe atopic dermatitis (AD)
- BREEZE-AD1 (N=624) and BREEZE-AD2 (N=615) compared baricitinib 1 mg, 2 mg, or 4 mg monotherapy to placebo in adult patients with inadequate response to topical corticosteroids (TCS).2
- BREEZE-AD4 (N=463) compared baricitinib 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 baricitinib 1 mg or 2 mg monotherapy to placebo in adult patients with inadequate response to TCS.4
- BREEZE-AD7 (N=329) compared baricitinib 2 mg or 4 mg in combination with TCS vs placebo with TCS in adult patients with inadequate response to topical medications.5
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 tuberculosis (TB) at screening defined as
- positive purified protein derivative (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.6
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.6
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.6
These patients were not required to undergo the protocol-specific TB testing for PPD, QuantiFERON®-TB Gold test, or T-SPOT® TB test.6
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.6
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.6
Patients With Atopic Dermatitis and Preexisting Tuberculosis
An analysis of the efficacy and safety of baricitinib 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 Tuberculosis in the Pivotal Phase 3 BREEZE-AD Trials (ITT Population).
Monotherapy Studies |
|
|||
BREEZE-AD1 |
Placebo |
BARI 1 mg |
BARI 2 mg |
BARI 4 mg |
Latent TB, n (%) |
1 (0.4) |
0 |
1 (0.8) |
0 |
BREEZE-AD2 |
Placebo |
BARI 1 mg |
BARI 2 mg |
BARI 4 mg |
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 |
Placebo |
BARI 1 mg |
BARI 2 mg |
NA |
Latent TB, n (%) |
1 (0.7) |
1 (0.7) |
1 (0.7) |
NA |
Combination Studies |
||||
BREEZE-AD4 |
Placebo |
BARI 1 mg |
BARI 2 mg |
BARI 4 mg |
Latent TB, n (%) |
0 |
0 |
1 (0.5) |
0 |
Mycobacterium TB complex test positive, n (%) |
1 (1.1) |
0 |
0 |
0 |
BREEZE-AD7 |
Placebo |
NA |
BARI 2 mg |
BARI 4 mg |
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.
References
1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
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
3Bieber T, Reich K, Paul C, et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis who failed, are intolerant to, or have contraindication to cyclosporine: results from a randomized, placebo-controlled, phase 3 clinical trial (BREEZE-AD4). Poster presented at: 29th European Academy of Dermatology and Venereology (EADV Virtual); October 29-31, 2020.
4Simpson EL, Forman S, Silverberg JI, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis: results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5). J Am Acad Dermatol. 2021;85(1):62-70. https://doi.org/10.1016/j.jaad.2021.02.028
5Reich K, Kabashima K, Peris K, et al. Efficacy and safety of baricitinib combined with topical corticosteroids for treatment of moderate to severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(12):1333-1343. https://doi.org/10.1001/jamadermatol.2020.3260
6Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: 16 May 2023