Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Olumiant® ▼ (baricitinib): Effektivitet och säkerhet hos patienter med komorbid lungfibros

Analyser av effekt och säkerhet av baricitinib hos patienter med måttlig till svår reumatoid artrit och komorbid lungfibros har inte utförts.

Use of BARI in Patients With Pulmonary Fibrosis and RA

Analyses of the efficacy and safety of BARI in patients with moderate-to-severe RA and comorbid pulmonary fibrosis have not been conducted due to low number of patients with comorbid pulmonary fibrosis.1

Exclusion Criteria Related to Pulmonary Fibrosis in the Baricitinib Clinical Trials

Pulmonary fibrosis was not a specific exclusion criterion in the pivotal phase 3 BARI trials: RA-BEAM, RA-BEACON, RA-BUILD, and RA-BEGIN.2

However, patients were excluded if they had a history or presence of a serious or unstable illness that, in the opinion of the investigator, could

  • constitute a risk when taking an investigational product, or

  • interfere with the interpretation of data.2

Patients With Comorbid Pulmonary Fibrosis

An analysis of the efficacy and safety of BARI in patients with moderate and severe RA and comorbid pulmonary fibrosis has not been conducted.1 In the 4 phase 3 BARI clinical trials in patients with RA, 7 patients treated with BARI 4 mg and 4 patients treated with BARI 2 mg had a pre-existing condition or historical diagnosis of pulmonary fibrosis.2

Clinical Recommendations for Patients With Pulmonary Fibrosis

Lilly cannot provide a recommendation on whether to use BARI in a patient with pulmonary fibrosis. The treating physician may use the information provided, the patient’s prior medical history and concomitant medications, and other individual factors, in formulating an assessment and approach. The treating physician should consider potential risks and benefits of treatment options, and monitor appropriately.

References

1. Combe B, Balsa A, Sarzi-Puttini P, et al. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019;[Epub ahead of print]. http://dx.doi.org/10.1136/annrheumdis-2018-214261

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

Glossary

BARI = baricitinib

Lilly = Eli Lilly and Company

RA = rheumatoid arthritis

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.

Datum fӧr senaste ӧversyn 2019 M05 15

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