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 Undergoing Surgery in the Atopic Dermatitis Clinical Program

There were no serious events or permanent discontinuation of baricitinib treatment associated with surgical and medical procedures reported in the atopic dermatitis clinical development program.

Risks Associated With Surgical Procedures in the BREEZE-AD Trials

Risks Associated With Surgical Procedures in Patients With Atopic Dermatitis

Patients with AD have an increased risk of developing secondary cutaneous infections, which may be bacterial, viral, or fungal in nature.1 The abnormal bacterial colonization of the AD-compromised skin can lead to serious complications such as

  • infective endocarditis

  • skin cellulitis

  • osteomyelitis, and

  • surgical site infections.2,3

Risk Associated With Infections in Patients Treated With Baricitinib

Baricitinib is a selective and reversible JAK1 and JAK2 inhibitor. Janus kinases are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in hematopoiesis, inflammation and immune function.4

Preclinical and clinical studies have implicated the immunosuppressive properties of JAK inhibitors to an increased risk of infectious complications in patients treated with these inhibitors.5

Warnings and Precautions Related to Infections

Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo.6

The risks and benefits of treatment with baricitinib should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections.6

If an infection develops, the patient should be monitored carefully and baricitinib therapy should be temporarily interrupted if the patient is not responding to standard therapy. Baricitinib treatment should not be resumed until the infection resolves.6

BREEZE-AD Clinical Trials Exclusion Criteria Related to Surgical Procedures

In the BARI AD clinical development program, patients were excluded if they have had any major surgery within 8 weeks prior to screening.4

Patients were also excluded if they would require major surgery during the study that, in the opinion of the investigator in consultation with the sponsor or its designee, would pose an unacceptable risk to the patient if participating in the trial.4

Planned surgeries and nonsurgical interventions were not reported as AEs unless the underlying medical condition had worsened during the course of the clinical studies.4

Surgical and Medical Procedures in the Atopic Dermatitis Clinical Program

The All BARI AD integrated dataset used to evaluate safety in the AD clinical trials are described in detail in Table 2.

The incidences of events by PT occurring within the surgical and medical procedures SOC in the BARI AD clinical trial program are summarized in Table 1.

Table 1. Treatment-Emergent Adverse Events Within the Surgical and Medical Procedures System Organ Class4

Events

All Doses
(N=2531)
n (%) [IR]

Surgical and medical procedures (SOC)

86 (3.4) [3.8]

Tooth extraction

17 (0.7) [0.7]

Wisdom teeth removal

12 (0.5) [0.5]

Dental implantation

6 (0.2) [0.3]

Cataract operation

4 (0.2) [0.2]

Cholecystectomy

3 (0.1) [0.1]

Skin neoplasm excision

3 (0.1) [0.1]

Mammoplasty

2 (0.1) [0.1]

Nasal septal operation

2 (0.1) [0.1]

Suture insertion

2 (0.1) [0.1]

Tooth repair

2 (0.1) [0.1]

Abortion induceda

1 (0.1) [0.1]

Adenoidectomy

1 (0.0) [0.0]

Appendicectomy

1 (0.0) [0.0]

Blepharoplasty

1 (0.0) [0.0]

Cardioversion

1 (0.0) [0.0]

Carpal tunnel decompression

1 (0.0) [0.0]

Circumcisionb

1 (0.1) [0.1]

Cryotherapy

1 (0.0) [0.0]

Cyst removal

1 (0.0) [0.0]

Dental care

1 (0.0) [0.0]

Dental operation

1 (0.0) [0.0]

Dental prosthesis placement

1 (0.0) [0.0]

Endodontic procedure

1 (0.0) [0.0]

Laser eye surgery

1 (0.0) [0.0]

Eye operation

1 (0.0) [0.0]

Fascial operation

1 (0.0) [0.0]

Fistula repair

1 (0.0) [0.0]

General anesthesia

1 (0.0) [0.0]

Hemorrhoid operation

1 (0.0) [0.0]

Hernia repair

1 (0.0) [0.0]

Incisional drainage

1 (0.0) [0.0]

Intervertebral disc operation

1 (0.0) [0.0]

Intraocular lens implant

1 (0.0) [0.0]

Intraocular lens repositioning

1 (0.0) [0.0]

Jaw operation

1 (0.0) [0.0]

Knee operation

1 (0.0) [0.0]

Large intestinal polypectomy

1 (0.0) [0.0]

Medical device removal

1 (0.0) [0.0]

Myopia correction

1 (0.0) [0.0]

Nail operation

1 (0.0) [0.0]

Papilloma excision

1 (0.0) [0.0]

Polypectomy

1 (0.0) [0.0]

Rehabilitation therapy

1 (0.0) [0.0]

Retinal operation

1 (0.0) [0.0]

Skin operation

1 (0.0) [0.0]

Tonsillectomy

1 (0.0) [0.0]

Turbinectomy

1 (0.0) [0.0]

Turbinoplasty

1 (0.0) [0.0]

Uvulopalatopharyngoplasty

1 (0.0) [0.0]

Vitrectomy

1 (0.0) [0.0]

Abbreviations: SOC= system organ class.

a Denominator and patient years adjusted because event is specific to females (N=994). 

b Denominator and patient years adjusted because event is specific to males (N=1537).

In the All BARI AD dataset evaluating 2531 patients treated across all BARI doses studied in AD, there were 86 (3.4%) TEAEs reported under the surgical and medical procedures SOC. Temporary interruption of treatment was reported in 4 (0.2%) events, which included one case each of

  • adenoidectomy (treatment interrupted for 9 days)

  • hernia repair (treatment interrupted for 36 days)

  • intervertebral disc operation (treatment interrupted for 1 day), and

  • intraocular lens repositioning (treatment interrupted for 3 days).4

None of the events were serious or led to discontinuation of study drug.4

Description of the ALL BARI AD Integrated Safety Dataset

Table 2. Integrated Analysis Datasets Used to Evaluate Safety in Atopic Dermatitis Clinical Trials4

Analysis Set

Description

All BARI AD

Studies:

  • JAHG

  • BREEZE-AD1

  • BREEZE-AD2

  • BREEZE-AD4

  • BREEZE-AD5

  • BREEZE-AD7, and

  • extension studies BREEZE-AD3, BREEZE-AD6

No between-group comparisons

Includes 2531 (total PYE=2247.4) patients with AD from 1 phase 2, 5 phase 3, and 2 phase 3 extension studies who received BARI at a variety of doses, including

  • BARI 1 mg (n=538, PYE=245.9)

  • BARI 2 mg (n=1580, PYE=1129.5), and

  • BARI 4 mg (n=914, PYE=872.8).

Includes all patients who were exposed to any BARI dose at any time during the studies, either from randomization or from switch or rescue from placebo.

 No censoring of data at dose change.

Abbreviations: AD = atopic dermatitis; BARI = baricitinib; PYE = patient-years of exposure.

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

References

1. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122. http://dx.doi.org/10.1016/S0140-6736(15)00149-X

2. Fukunaga N, Yuzaki M, Shomura Y, et al. Clinical outcomes of open heart surgery in patients with atopic dermatitis. Asian Cardiovasc Thorac Ann. 2012;20(2):137-140. https://doi.org/10.1177/0218492311433311

3. Kawata M, Sasabuchi Y, Taketomi S, et al. Atopic dermatitis is a novel demographic risk factor for surgical site infection after anterior cruciate ligament reconstruction. Knee Surg, Sports Traumatol, Arthrosc. 2018;26(12):3699-3705. http://dx.doi.org/10.1007/s00167-018-4958-7

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

5. Reinwald M, Boch T, Hofmann WK, et al. Risk of infectious complications in hemato-oncological patients treated with kinase inhibitors. Biomark Insights. 2016;10(suppl 3):55-68. https://doi.org/10.4137/BMI.S22430

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

Glossary

AD = atopic dermatitis

AE = adverse event

BARI = baricitinib

JAK = Janus kinase

PT = preferred term

SOC = system organ class

TEAE = treatment-emergent adverse event

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: July 20, 2020


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