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 komorbida kardiovaskulära sjukdomar

Effekt och säkerhet av baricitinib 4mg hos patienter med måttlig till svår reumatoid artrit och komorbida kardiovaskulära sjukdomar liknar den totala populationen.

Exclusion Criteria Related to Interstitial Lung Disease in the Baricitinib Clinical Trials

Interstitial lung disease was not a specific exclusion criterion in the pivotal phase 3 BARI trials: RA-BEAM, RA-BEACON, RA-BUILD, and RA-BEGIN.1

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.1

Patients With Comorbid Interstitial Lung Disease

An analysis of the efficacy and safety of BARI in patients with moderate and severe RA and comorbid ILD has not been conducted. In the 4 phase 3 BARI clinical trials in patients with RA, 6 patients treated with BARI 4 mg and 3 patients treated with BARI 2 mg had a pre-existing condition or historical diagnosis of ILD.1,2

Clinical Recommendations for Patients With Comorbid Interstitial Lung Disease

Lilly cannot provide a recommendation on whether to use BARI in a patient with ILD. 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. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. 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

Glossary

BARI = baricitinib

ILD = interstitial lung disease

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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