Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Användning hos patienter med nedsatt njurfunktion

Användning med levande, försvagat vaccin under eller omedelbart före är baricitinibbehandling rekommenderas inte.

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Baricitinib Label Information Related to Vaccinations

Warnings and Precautions Related to Vaccinations

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.1

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

Vaccine Study

The influence of baricitinib on the humoral response to non-live vaccines was evaluated in 106 RA patients under stable treatment with baricitinib 2 or 4 mg, receiving

  • inactivated pneumococcal or
  • tetanus vaccination.1

The majority of these patients (n = 94) were co-treated with methotrexate. For the total population, pneumococcal vaccination resulted in a satisfactory IgG immune response in 68.0 % (95 % CI: 58.4 %, 76.2 %) of the patients.  In 43.1 % (95 % CI: 34.0 %, 52.8 %) of the patients, a satisfactory IgG immune response to tetanus vaccination was achieved.1

Use of Potential COVID-19 Vaccines with Baricitinib

The efficacy and safety of COVID-19 vaccines in patients being treated with BARI have not been studied by Eli Lilly and Company. 

The safety and efficacy of BARI used in patients that have received a COVID-19 vaccine has not been studied by Eli Lilly and Company.

Decisions regarding the use of any vaccination, including SARS-CoV-2 vaccines, in patients treated with BARI should be made at the discretion of the prescribing physician using their best clinical judgment, and must be made by the clinician after careful consideration of risk factors of the patient as well as the risks and benefits of vaccination. Consultation with an infectious disease expert may be helpful in high-risk or emergency situations such as the current COVID-19 pandemic.

SARS-CoV-2 Vaccination Types

According to current available information on SARS-CoV-2 vaccines being developed, the majority are nonlive.2 However, this is an unprecedented and evolving situation, so it is advisable to check for updated information. For the most up-to-date information regarding each vaccine in development, including the type of each vaccine, please see

Use of Live Vaccinations with Baricitinib

Live vaccines, including HZ vaccination, were prohibited during clinical studies. Investigators were instructed to monitor patients for clinical signs and symptoms of infectious events, including HZ. Patients at risk for HZ could have received a HZ vaccination

  • >30 days prior to start of study medication in RA trials, or
  • >4 weeks prior to start of study medication in AD trials.3

Use of Nonlive Vaccinations with Baricitinib

Nonlive Seasonal and Emergency Vaccinations

Nonlive seasonal vaccinations and emergency vaccinations, such as rabies or tetanus, were allowed during the BARI phase 3 clinical programs in RA and AD.3

Nonlive Herpes Zoster Vaccination

No information is available regarding the use of BARI with a nonlive HZ vaccine because

  • nonlive 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.

In AD clinical studies, patients who initiated vaccination with the nonlive herpes vaccine before the trial, must have had the second vaccine dose at least 4 weeks prior to randomization.3

Substudy Evaluating Patient Response to Pneumococcal and Tetanus Vaccinations

A substudy in the BARI RA phase 3 long-term extension clinical trial, RA-BEYOND, evaluated patient response to pneumococcal conjugate and tetanus toxoid vaccines while receiving BARI treatment for RA.4

One hundred six patients from the United States or Puerto Rico received BARI 2 mg or 4 mg treatment, out of whom 94 (89%) received concomitant methotrexate.4

Substudy Results

Antibody IgG concentrations were measured at prevaccination, and 5 and 12 weeks postvaccination. Geometric mean concentrations of pneumococcal serotypes and tetanus antibodies are presented in Geometric Mean Concentrations of Antibodies.4

Geometric Mean Concentrations of Antibodies4

Abbreviations: IgG = immunoglobulin G; PCV-13 = 13-serotype pneumococcal conjugate vaccine; TTV = tetanus toxoid vaccine.

A. Anti-pneumococcal serotype-specific IgG antibodies.

B. Anti-tetanus IgG antibodies.

Response to Pneumococcal Vaccine

A satisfactory humoral response to Prevnar13 was defined as a ≥2-fold increase in anti-pneumococcal antibody titers in ≥6/13 serotypes from baseline to 5 weeks post-vaccination.4,5

Of the 103 patients who completed the evaluations, a satisfactory humoral response was achieved by

  • 70 (68%; 95% CI, 58.4,76.2) at week 5, and
  • 64 (66%; 95% CI 56.1,74.6) at week 12.3,4

Humoral response by dose, age, corticosteroid use, and baseline SDAI are presented in Patients Who Achieved Humoral Response at Week 5 PostVaccination by Subgroup.

Response to Tetanus Vaccine

A satisfactory humoral response to Boostrix was defined as a ≥4-fold increase in anti-tetanus titers from baseline to 5 weeks post-vaccination. Evaluated patients had ≥0.1 IU/mL anti-tetanus antibody titer at baseline.4,5

Of the 102 patients who completed the evaluations, a satisfactory humoral response was achieved by

  • 44 (43%; 95% CI, 34.0, 52.8) at week 5, and
  • 28 (29%; 95% CI, 21.0, 38.9) at week 12.3,4

At week 5, 74% (n=75; 95% CI, 64.2, 81.1) of patients had a ≥2-fold increase in anti-tetanus titers from a baseline of ≥0.1 IU/mL.4

Humoral response by dose, age, corticosteroid use, and baseline SDAI are presented in Patients Who Achieved Humoral Response at Week 5 PostVaccination by Subgroup.

Patients Who Achieved Humoral Response at Week 5 PostVaccination by Subgroupa4,5


Pneumococcal Vaccine,b n (%)

Tetanus Vaccine,c n (%)

Overall BARI group (N=106)

70 (68)

44 (43)

Concomitant corticosteroids

Yes (N=31)

22 (71)

16 (52)

No (N=72)

48 (67)

28 (39)

Age group

Patients <65 years (N=80)

59 (74)

37 (46)

Patients ≥65 years (N=23)

11 (48)

7 (32)

SDAI prior to vaccination

≤3.3 (N=21)

13 (62)

11 (55)

>3.3 and ≤11 (N=47)

34 (72)

20 (43)

>11 (N=32)

21 (66)

13 (41)

BARI dose

2 mg (N=16)

11 (69)

5 (33)

4 mg (N=87)

59 (68)

39 (45)

Abbreviations: BARI = baricitinib; SDAI = Simplified Disease Activity Index.

aA satisfactory humoral response to the pneumococcal vaccine was defined as a ≥2-fold increase in anti-pneumococcal antibody titers in ≥6/13 serotypes from baseline to 5 weeks post-vaccination. A satisfactory humoral response to tetanus vaccine was defined as a ≥4-fold increase in anti-tetanus titers from baseline to 5 weeks post-vaccination in patients with ≥0.1 IU/mL anti-tetanus antibody titer at baseline.

bPrevnar13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).

cBoostrix® (tetanus toxoid vaccine, reduced diphtheria toxoid, and acellular pertussis vaccine, absorbed).

Safety Results

Overall, during the vaccine substudy, 

  • 28.3% (n=30) of patients had reported adverse events, and
  • 2.8% (n=3) of patients had reported serious adverse events.4

Through 12 weeks post-vaccination, there were

  • 7 reports of injection site events possibly related to vaccination, and 
  • 2 reports of moderate pain.4

Of the 3 reported serious adverse events, none were considered related to the vaccines.4

Vaccination Treatment Guidelines in Patients With Rheumatoid Arthritis

Recommendations for the vaccination of adult patients with RA have been published by the American College of Rheumatology and the European League against Rheumatism.6,7 Direct links to each are available in the list of references.

Information regarding vaccination against SARS-CoV-2 has been published by the

Vaccination Treatment Guidelines in Patients With Atopic Dermatitis

Recommendations for the vaccination of adult patients with AD have been published by the the European Academy of Dermatology and Venerology.10 A direct link is available in the list of references.

Vaccination Resources

Information on immunisation and vaccines can be found on the European Centre for Disease Prevention and Control Portal at

https://www.ecdc.europa.eu/en/immunisation-and-vaccines

Confirmation of whether a specific vaccination is live vs nonlive/inactivated can also be found in the manufacturer’s product labeling.

References

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

2Draft landscape of COVID-19 candidate vaccines. World Health Organization (WHO). November 12, 2020. Accessed December 4, 2020. https://www.who.int/docs/default-source/blue-print/novel-coronavirus-landscape-covid-19-(7).pdf?sfvrsn=a4e55ae3_2&download=true

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

4Winthrop KL, Bingham CO, Komocsar WJ, et al. Evaluation of pneumococcal and tetanus vaccine responses in patients with rheumatoid arthritis receiving baricitinib: results from a long-term extension trial substudy. Arthritis Res Ther. 2019;21(1):102. https://dx.doi.org/10.1186/s13075-019-1883-1

5Winthrop KL, Bingham CO, Bradley J, et al. Evaluation of pneumococcal and tetanus vaccine responses in patients with rheumatoid arthritis receiving baricitinib: results from a long-term extension trial substudy [abstract 1824]. Arthritis Rheumatol. 2017a;69(suppl 10). http://acrabstracts.org/abstract/evaluation-of-pneumococcal-and-tetanus-vaccine-responses-in-patients-with-rheumatoid-arthritis-receiving-baricitinib-results-from-a-long-term-extension-trial-substudy/

6Furer V, Rondaan C, Heijstek MW, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020;79(1):39-52. http://dx.doi.org/10.1136/annrheumdis-2019-215882

7Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2016;68(1):1-26. http://dx.doi.org/10.1002/art.39480

8February 2021 update: information from the American College of Rheumatology regarding vaccination against SARS-CoV-2. American College of Rheumatology. February 1, 2021. Accessed February 5, 2021. https://www.rheumatology.org/Portals/0/Files/ACR-Information-Vaccination-Against-SARS-CoV-2.pdf

9Bijlsma JW. EULAR December 2020 View points on SARS-CoV-2 vaccination in patients with RMDs. Ann Rheum Dis. Published online February 9, 2021. http://dx.doi.org/10.1136/annrheumdis-2020-219773

10Wollenberg A, Barbarot S, Bieber S, et al. Consensus‐based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2018;32 (5):657-682. https://doi.org/10.1111/jdv.14891

11European Academy of Dermatology and Venereology. Covid-19 Vaccination: Advice of the EADV Task Forces. Published January 2021. Assessed March 2021. https://www.eadv.org/cms-admin/showfile/COVID-19%20VACCINATION%20-%20TF%20ADVICE_02-10-2021-13-12-40.pdf

12COVID-19 Vaccine Administration Guidance. American Academy of Dermatology Association. January 21, 2021. Accessed February 1, 2021. https://assets.ctfassets.net/1ny4yoiyrqia/2gTpp7G9GNSTtAHwPHNtbc/b4318dd9e1c47968bb8532a961cbd39e/COVID_vaccine_administration_guidance_1-20-2021.pdf

13Thyssen JP, Vestergaard C, Barbarot S, et al. European Task Force on Atopic Dermatitis (ETFAD): position on vaccination of adult patients with atopic dermatitis against COVID-19 (SARS-CoV-2) being treated with systemic medication and biologics. J Eur Acad Dermatol Venereol. Published online February 15, 2021. https://doi.org/10.1111/jdv.17167

Glossary

AD = atopic dermatitis

AE = adverse event

BARI = baricitinib

Boostrix = Boostrix® (tetanus toxoid vaccine, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed)

COVID-19 = coronavirus disease 2019

HZ = herpes zoster

Ig = immunoglobulin

Prevnar = Prevnar13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])

RA = rheumatoid arthritis

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

SDAI = Simplified Disease Activity Index

Datum fӧr senaste ӧversyn 2021 M03 04


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