Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Användning hos patienter med COVID-19 (coronavirus disease 2019)

Baricitinib är ett selektivt immunosuppressivt medel, vilket har associerats med en ökad frekvens av infektioner. Eli Lilly har inte studerat effekten av Coronavirus (COVID-19) på baricitinib-behandling.

Risk of infection with COVID-19 in patients treated with baricitinib

Specific information related to the risk of coronavirus infection in patients treated with baricitinib is not available.

Eli Lilly and company has not studied the use of baricitinib in patients at risk of contracting the COVID-19.1

Use of baricitinib in patients with COVID-19

Eli Lilly and company has not studied the use of baricitinib in patients with COVID-19.1

Infection-Related Warnings and Precautions

Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo. In treatment naïve patients, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.2

  • The risks and benefits of treatment with baricitinib should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections.2

  • If an infection develops, the patient should be monitored carefully and baricitinib therapy should be temporarily interrupted if the patient is not responding to standard therapy. Baricitinib treatment should not be resumed until the infection resolves.2

The decision on treatment remains at the discretion of prescribing physician.

Incidence of Infections in Baricitinib Clinical trials

Upper Respiratory Tract Infections

Upper respiratory tract infections were very commonly (≥10%) reported adverse events in RA BARI clinical trials.1

Table 1. Infections and Upper Respiratory Tract Infections From Rheumatoid Arthritis Clinical Trials in the Placebo-Controlled Period1,3,4

 

7-Study Dataseta
(to Week 24)

n (EAIR)

Placebo
N=1215
PYE=450.8

BARI 2 mg
N=479
PYE=185.8

BARI 4 mg
N=1142
PYE=471.8

All TE Infection

340 (75.4)

156 (84.0)

423 (89.7)

Upper Respiratory Tract Infectionsb

184 (40.8)

91 (49.0)

224 (47.5)

Abbreviations: BARI = baricitinib; EAIR = exposure adjusted incidence rate; IR = incidence rate; PYE = patient-years of exposure; TE = treatment emergent.

a 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. Patients in the placebo group could have been taking background MTX or other conventional DMARDs. 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. 

b Includes acute sinusitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, sinobronchitis, tonsillitis, tracheitis, and upper respiratory tract infection.

Serious Infections in Rheumatoid Arthritis Clinical Trials

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

  • 10,127 PYE, and

  • up to 6.9 years of exposure.3,4

Of the 3770 patients who received BARI in the RA clinical trials through 13 February 2018, there were 283 TE serious infections with an IR per 100 PYE, censored at time of event, of 2.8. The most frequent serious infections reported were

  • pneumonia (n=52, EAIR 0.5)

  • HZ (n=35, EAIR 0.4)

  • urinary tract infection (n=21, EAIR 0.2)

  • cellulitis (n=15, EAIR 0.2)

  • sepsis (n=18 including 14 cases of sepsis and 4 cases of urosepsis), and

  • gastroenteritis (n=13, EAIR 0.13).1,3,4

Clinical Factors Associated with Serious Infection

A large group of clinical factors with the potential to affect the risk of serious infection was evaluated using Cox models and data from the All BARI RA dataset through 01 January 2016. The 5 independent risk factors identified for serious infection were

  • prior biologic use

  • advanced age

  • Asian region of study enrollment, excluding Japan

  • non-normal body mass index, and

  • concomitant corticosteroid use.5

Additionally, increasing grades of lymphopenia were associated with an increase in frequency of any TE infection and serious infection in BARI-treated patients.1

Background information related to infection

Infections belong to the known adverse drug reactions of baricitinib:2

  • Very common:

    • upper respiratory tract infection (combined term: acute sinusitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, tracheitis, upper respiratory tract infection)

  • Common:

    • Herpes zoster

    • Herpes simplex (combined term: eczema herpeticum, herpes simplex, ophthalmic herpes simplex, oral herpes)

    • Gastroenteritis

    • Urinary tract infections

    • Pneumonia

The most commonly reported adverse drug reactions (ADRs) occurring in ≥ 2 % of patients treated with baricitinib monotherapy or in combination with conventional synthetic DMARDs were increased LDL cholesterol (33.6 %), upper respiratory tract infections (14.7 %) and nausea (2.8 %). Infections reported with Baricitinib treatment included Herpes zoster.2

In controlled studies, for up to 16 weeks, the incidence rate of all infections (rate of patients with ≥ 1 event per 100 patient-years of exposure) was 101 with baricitinib compared to 83 in the placebo group. Most infections were mild to moderate in severity. In studies which included both doses, infections were reported in 31.9 %, 28.8 % and 24.1 % of patients up to 16 weeks in the 4 mg, 2 mg and placebo groups, respectively. Reporting rates for baricitinib compared to placebo for the infection-related ADRs were: Upper respiratory tract infections (14.7 % vs. 11.7 %), urinary tract infections (3.4 % vs. 2.7 %), gastroenteritis (1.6 % vs. 0.8 %), herpes simplex (1.8 % vs. 0.7 %), and herpes zoster (1.4 % vs. 0.4 %). In treatment-naïve patients, for up to 52 weeks, the frequency of upper respiratory tract infections was greater for the combination treatment of methotrexate and baricitinib (26.0 %) compared to methotrexate alone (22.9 %) or baricitinib alone (22.0 %). The rate of serious infections with baricitinib (1.1 %) was similar to placebo (1.2 %). For baricitinib, the most common serious infections were herpes zoster, and cellulitis. The rate of serious infections remained stable during long term exposure. The overall incidence rate of serious infections in the clinical trial programme was 3.2 per 100 patient-years.2

Infectious Disease Resources

For the most current information regarding the coronavirus, please refer to the websites of local health authorities and/or the WHO website at WHO Coronavirus disease (COVID-19) outbreak.

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.

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. 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.

5. Winthrop KL, Genovese MC, Harigai M, et al. Serious infection and associated risk factors in patients with moderate to severe rheumatoid arthritis treated with baricitinib [abstract OP0248]. Ann Rheum Dis. 2017;76(suppl 2):158. http://ard.bmj.com/content/76/Suppl_2/158.2

Glossary

BARI = baricitinib

EAIR = exposure-adjusted incidence rate

PYE = patient-years of exposure

RA = rheumatoid arthritis

TE = treatment-emergent

WHO = World Health Organization

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 M02 27

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