Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼(baricitinib): Bältros

Behandling med Olumiant (baricitinib) hade en högre förekomst av herpes zoster jämfört med placebo.

Information from the label

Herpes zoster was commonly reported with baricitinib in placebo-controlled studies for up to 16 weeks (≥ 1/100 to < 1/10). Reporting rates for baricitinib compared to placebo for herpes zoster were 1,4 % vs. 0,4 %.1

Herpes Zoster in Clinical Studies

Incidence of Herpes Zoster in Baricitinib Clinical Trials

The HZ cluster of preferred terms was used to identify cases of HZ in the BARI safety database. 

Incidence rates were calculated as the number of patients with an event per 100 patient-years of exposure time, with exposure censored at time of event.2

Herpes zoster IRs for safety integrated analysis sets through 13 February 2018 are presented in Figure 1. Herpes Zoster Incidence Rate by Analysis Dataset through 13 February 2018 

Figure 1. Herpes Zoster Incidence Rate by Analysis Dataset through 13 February 20182

Abbreviations: BARI = baricitinib; IR = incidence rate; PYE = patient-years exposure; RA = rheumatoid arthritis.

*p<.05 for BARI 4 mg vs placebo

Maximum severity: mild, 41.5%; moderate, 53.3%; severe, 5.2%.


7-Study Placebo-Controlled 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 in the placebo group 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.2,3

Data from BARI 2 mg (N=479, PYE=185.8) is 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).2,3

Incidence

Through 24 weeks of assigned treatment or until rescue, the HZ IR for BARI 4-mg group (3.8) was statistically significantly higher than the placebo group (0.9; p<.05) and numerically higher than BARI 2-mg group (3.1).3

4-Study Extended Dataset

Description

The extended dataset included patients with RA randomized to BARI 4 mg (N=479, PYE=698.6) or BARI 2 mg (N=479, PYE=675.6) from 2 phase 2 and 2 phase 3 studies (RA-BUILD, RA-BEACON) and 1 long term extension study (RA-BEYOND). The evaluation time periods included randomization through last available observation incorporating extension data through 13 February 2018 unless otherwise specified. Data were censored at rescue or dose change.2,3

Incidence

In the 4-study extended dataset through 13 February 2018, the IR of HZ infections was numerically but not statistically significantly higher in the BARI 4-mg group (IR=3.9) than the BARI 2-mg group (IR=2.7).3 For more information see Figure 1. Herpes Zoster Incidence Rate by Analysis Dataset through 13 February 2018 .

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, RA-BALANCE). Data includes a long-term extension study (RA-BEYOND) with

  • data through 13 February 2018, and

  • 10,127 PYE.2,3

Herpes Zoster Events and Case Details

Of the 3770 patients who received BARI in clinical trials for the treatment of RA through 13 February 2018,

  • 323 had a treatment-emergent case of HZ, and

  • the overall IR was 3.3/100 PYs of observation.3

Of the 323 HZ cases reported through 13 February 2018,

  • 95% of cases were mild to moderate in severity

  • 8% of cases were multidermatomal, and

  • 0 had visceral involvement.4

Risk Factor Analyses

Based on multivariate analyses, a higher risk of HZ was associated with

  • older age ( ≥50 vs <50, HR=1.88 [95% CI 1.43, 2.48]), and

  • the geographical region of Asia (Asia vs USA+Canada, HR=1.86 [95% CI 1.30, 2.66]).4

Zoster Virus Reactivation

Herpes zoster, or shingles, is caused by the reactivation of varicella zoster virus. Risk factors for varicella zoster virus reactivation include older age and a compromised immune system.5

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies. Herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and conventional DMARDs. If a patient develops herpes zoster, baricitinib treatment should be temporarily interrupted until the episode resolves.1

Follow Local Guidance When Administering Vaccines

No data are available on the response to vaccination with live vaccines in patients receiving baricitinib. Use with live, attenuated vaccines during, or immediately prior to, baricitinib therapy is not recommended. Prior to initiating baricitinib, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.1

For further information please refer to "EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases" available on the EULAR website.6

No information is available regarding the use of BARI with a non-live HZ vaccine because

  • non-live HZ vaccine was not available at the time of the RA phase 3 studies, and

  • no additional studies with the non-live vaccine have been conducted.

Indication

References

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

2. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Presented as an oral presentation at: European League Against Rheumatism (EULAR) Annual Meeting; June 12-15, 2019; Madrid, Spain.

3. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Ann Rheum Dis. 2019;78(2):308-309. http://dx.doi.org/10.1136/annrheumdis-2019-eular.691

4. Chen YH, Chen YM, Smolen J, et al. Incidence rate and characterisation of herpes zoster events in patients with moderate to severe rheumatoid arthritis: an update from baricitinib clinical trials. Poster presented at: European League Against Rheumatism (EULAR) Annual Meeting; June 12-15, 2019; Madrid, Spain.

5. Schub D, Janssen E, Leyking S, et al. Altered phenotype and functionality of varicella zoster virus-specific cellular immunity in individuals with active infection. J Infect Dis. 2015;211(4):600-612. http://dx.doi.org/10.1093/infdis/jiu500

6. EULAR.org [Internet] van Assen S et al. EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 2011;70:414-422. doi:10.1136/ard.2010.137216 [online] 2010. [cited 2017 Dec 18]. Available from:  http://www.eular.org/recommendations_management.cfm http://www.eular.org/recommendations_management.cfm

Glossary

BARI = baricitinib

DMARD = disease-modifying antirheumatic drug

HZ = herpes zoster

IR = incidence rate

MTX = methotrexate

PY(s) = patient year(s)

PYE = patient-years of exposure

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 M02 22

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