Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Behandlingsvbrott och dödsfall i kliniska studier med RA

I det kliniska utvecklingsprogrammet för reumatoid artrit rapporterades permanent avbrott av baricitinib på grund av en biverkning med en Exponeringsjusterad Incidens (EAIR) av 4,8.

All Baricitinib Rheumatoid Arthritis Dataset

All BARI RA 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, 2019.1,2

Incidence of Permanent Discontinuation due to Treatment-Emergent Adverse Events in the All BARI RA Analysis Set 

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.3

In the All BARI RA analysis set through September 1, 2019, permanent discontinuation due to an adverse event was reported in 644 (17.1%, EAIR=4.8) patients (Table 1).

Of all permanent discontinuations

  • events classified as severe were reported in 292 (7.7%, EAIR=2.2) patients, and

  • events possibly related to study drug per the investigator were reported in 357 (9.5%, EAIR=2.7) patients.3

Table 1. Adverse Events Leading to Permanent Discontinuation by System Organ Class3

Classification

Incidence, n (%)

EAIR

Infections and infestations

176 (4.7)

1.3

Neoplasms benign, malignant, and unspecified

124 (3.3)

0.9

Investigations

62 (1.6)

0.5

Blood and lymphatic system disorders

53 (1.4)

0.4

Respiratory, thoracic, and mediastinal disorders

36 (1.0)

0.3

Hepatobiliary disorders

27 (0.7)

0.2

Gastrointestinal disorders

25 (0.7)

0.2

Musculoskeletal and connective tissue disorders

22 (0.6)

0.2

Cardiac disorders

21 (0.6)

0.2

Nervous system disorders

19 (0.5)

0.1

Pregnancy, puerperium, and perinatal conditions

17 (0.5)

0.1

General disorders and administration site conditions

13 (0.3)

0.1

Vascular disorders

12 (0.3)

0.1

Injury, poisoning, and procedural complications

8 (0.2)

0.1

Renal and urinary disorders

8 (0.2)

0.1

Skin and subcutaneous tissue disorders

7 (0.2)

0.1

Reproductive system and breast disorders

4 (0.1)

0.0

Metabolism and nutrition disorders

3 (0.1)

0.0

Psychiatric disorders

3 (0.1)

0.0

Immune system disorders

2 (0.1)

0.0

Ear and labyrinth disorders

1 (0.0)

0.0

Surgical and medical procedures

1 (0.0)

0.0

Abbreviation: EAIR = exposure-adjusted incidence rate.

Incidence of Deaths in the All BARI RA Analysis Set

In the All BARI RA analysis set through September 1, 2019, death was reported in 70 of 3770 (IR 0.53) patients including

  • 12 of 1077 (IR 0.51) patients that were ever on BARI 2 mg

  • 56 of 3400 (IR 0.53) patients that were ever on BARI 4 mg, and

  • 2 of 373 (IR 1.03) patients that were ever on other BARI doses.2,3

The IR for death increased in later time intervals, however, when adjusting for aging of the cohort, there were no apparent increases (Figure 1).2

Figure 1. Deaths Over Time in the all Baricitinib Rheumatoid Arthritis Analysis2

Abbreviations: BARI = baricitinib; IR = incidence rate per 100 patient-years (exposure time censored at event); PYE = patient-years of exposure; RA = rheumatoid arthritis.

a Incidence rates were standardized to the WHO world population during 2000-2025 using 5‑year age increments within each reported 48-week time period to account for aging of the All-BARI-RA cohort over the 6 years of the reported data.

References

1. Genovese 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

2. Genovese 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.

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

Glossary

BARI = baricitinib

EAIR = exposure-adjusted incidence rate

IR = incidence rate

PYE = patient-years of exposure

RA = rheumatoid arthritis

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.

Datum fӧr senaste ӧversyn 2020 M07 24


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