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): Effekt och säkerhet hos patienter med komorbid Sjögrens syndrom

Det har inte utförts några analyser av effekt och säkerhet för BARI på patienter med måttlig till allvarlig reumatoid artrit och komorbid Sjögrens syndrom.

Exclusion Criteria Related to Sjogren's Syndrome in the Baricitinib Rheumatoid Arthritis Clinical Trials

Patients with Sjogren’s syndrome were not excluded from the RA phase 3 clinical trial program.1

Patients With Comorbid Sjogren's Syndrome

In the phase 3 BARI clinical trials in patients with RA, 45 patients treated with BARI had a preexisting condition or historical diagnosis of Sjogren’s syndrome.1

Clinical Recommendations for Patients With Sjogren's Syndrome

Eli Lilly and Company cannot provide a recommendation on whether to use BARI in a patient with Sjogren’s syndrome. 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.

Baricitinib Indication

Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate.2

References

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

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

Glossary

BARI = baricitinib

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 2020 M04 30


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