Olumiant® (Baricitinib)

Para consultar la información para prescribir completa de Olumiant® (Baricitinib) de clic en el siguiente enlace: Información para prescribir

La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.

Baricitinib: Incidence of Herpes Simplex in the Rheumatoid Arthritis Clinical Development Program

In the rheumatoid arthritis clinical development program, 157 (4.2%) patients reported a treatment-emergent adverse event of herpes simplex.

MX_cFAQ_BAR114A_HERPES_SIMPLEX_RA
MX_cFAQ_BAR114A_HERPES_SIMPLEX_RA
es-MX

Baricitinib Prescribing Information

Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections. Use in caution in patients with clinically important chronic or active infection.1

If infection develops

  • monitor carefully
  • if patient is not responding to standard treatment interrupt BARI therapy, and
  • do not resume BARI until infection is resolved.1

Viral reactivation, including cases of herpes virus reactivation (eg, herpes zoster), were reported in clinical studies with BARI. If a patient develops herpes zoster, BARI treatment should be interrupted until the episode resolves.1

In BARI clinical trials, herpes simplex was commonly reported (≥1% and <10%).1

Incidence of Herpes Simplex in the Rheumatoid Arthritis Clinical Development Program

Herpes simplex is a cluster of the MedDRA preferred terms of herpes simplex, oral herpes, eczema herpeticum, Kaposi's varicelliform eruption, ophthalmic herpes simplex, genital herpes, and genital herpes simplex.1

Treatment-Emergent Adverse Events

A TEAE is an adverse event that either occurred or worsened in severity after the first dose of study treatment and did not necessarily have a causal relationship to study treatment.1

7-Study Placebo-Controlled Dataset

Dataset Description

The 7-study pooled dataset included patients with RA randomized to BARI 4 mg (N=1142, PYE=471.8) or placebo (N=1215, PYE=450.8) from 3 phase 2 studies and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON, and RA-BALANCE). Patients could have been taking background MTX or other conventional DMARDs. Evaluation time periods included through

  • the 12-week placebo-controlled period in phase 2 studies
  • 16 weeks of assigned treatment before any opportunity for rescue therapy in phase 3 studies, and
  • 24 weeks of assigned treatment or until rescue in phase 3 studies.2

Data from BARI 2 mg (N=479, PYE=185.8) were derived from 4 of these studies in which both BARI 2 mg and BARI 4 mg were options during randomization (2 phase 2 studies as well as RA-BUILD and RA-BEACON).2

Incidence of Herpes Simplex

In this safety analysis, through 24 weeks of treatment, the TEAE of

  • herpes simplex was reported in
    • 24 (2.1%) patients in the BARI 4 mg group
    • 6 (1.3%) patients in the BARI 2 mg group, and
    • 10 (0.8%) patients in the placebo group.1

All Baricitinib Rheumatoid Arthritis Dataset

Dataset Description

The All BARI RA analysis set included 3770 patients with RA who received BARI at a variety of doses from 1 phase 1, 3 phase 2, and 5 phase 3 studies (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, and RA-BALANCE). Data includes a long-term extension study (RA-BEYOND) with

  • 13,148 PYE
  • median exposure of 4.2 years
  • maximum exposure of 8.4 years, and
  • data through September 1, 2019.3,4

Incidence of Herpes Simplex

In the All BARI RA analysis set through September 1, 2019, a TEAE of

  • herpes simplex was reported in 157 (4.2%) patients.1

Of these 157 TEAEs of herpes simplex, 

  • 2 were reported as serious adverse events
  • 33 resulted in temporary interruption of BARI, and
  • 9 resulted in permanent discontinuation of BARI.1

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis over a median of 3 years of treatment: an updated integrated safety analysis. Lancet Rheumatol. 2020;2(6):E347-E357. https://doi.org/10.1016/S2665-9913(20)30032-1

3Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis [abstract]. Ann Rheum Dis. 2020;79(suppl 1):638. https://ard.bmj.com/content/79/Suppl_1/642.1

4Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis. Poster presented at: European League Against Rheumatism Virtual Congress; June 3-6, 2020.

Glossary

BARI = baricitinib

DMARD = disease-modifying antirheumatic drug

MedDRA = Medical Dictionary for Regulatory Activities

MTX = methotrexate

PYE = patient-years of exposure

RA = rheumatoid arthritis

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2020 M07 16


Contáctenos para saber más de la información Médica de Lilly

Contacto vía correo electrónico

Correo electrónico: infomed@lilly.com

Envíe su consulta

Escriba su consulta