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Olumiant ® (baricitinib)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Can Olumiant® (baricitinib) Be Used with Vaccines?
Live, attenuated vaccines are not recommended for use during or immediately prior to therapy with baricitinib.
Content overview
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 treatment, it is recommended that all patients, and particularly paediatric patients, be brought up to date with all immunisations in agreement with current immunisation guidelines.1
Live vaccines were prohibited during the baricitinib clinical trials. Investigators were instructed to monitor patients for clinical signs and symptoms of infectious events.2
Use of Vaccines with Baricitinib
|
Live vaccines |
Non Live vaccines (Inactivated vaccines) |
Herpes zostera |
Live vaccines, including herpes zoster (HZ) vaccination, were prohibited during clinical studies. Patients at risk for HZ could have received a HZ vaccination
In the AA clinical studies, if a live HZ vaccine was administered to a patient, investigational product was temporarily interrupted for 4 weeks after the injection.3 |
No information is available regarding the use of baricitinib with a non-live HZ vaccine, because:
In the atopic dermatitis and alopecia areata clinical studies, patients who initiated vaccination with the non-live herpes vaccine before the trial, must have had the second vaccine dose at least 4 weeks prior to randomization.2
In the alopecia areata clinical trials, nonlive HZ vaccines were permitted for subjects who became eligible during the trial and did not require interruption of investigational product.3 |
COVID vaccines |
The efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines, including boosters, in patients being treated with baricitinib have not been studied by Eli Lilly and Company. The safety and efficacy of baricitinib used in patients that have received a COVID-19 vaccine have not been studied by Eli Lilly and Company. Decisions regarding the use of any vaccination, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, in patients treated with baricitinib 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. According to currently available information on COVID-19 vaccines, the majority are nonlive.4 Confirmation of whether a specific vaccination is life vs nonlive/inactivated can also be found in the manufacturer’s product labelling. |
|
Monkeypox Vaccines |
The efficacy and safety of monkeypox vaccines in patients being treated with baricitinib have not been studied by Eli Lilly and Company. The vaccines currently available for monkeypox are live vaccines.5 No data are available on the response to vaccination with live vaccines in patients receiving baricitinib. Avoid the use of live vaccines with baricitinib.2 Confirmation of whether a specific vaccination is live vs nonlive/inactivated can be found in the manufacturer’s product labelling. |
N/A |
Non-live seasonal and emergency vaccinations |
N/A |
Non-live seasonal vaccinations and emergency vaccinations, such as rabies or tetanus, were allowed during the baricitinib phase 3 clinical programs in rheumatoid arthritis, atopic dermatitis and alopecia areata.2 |
Inactivated Pneumococcal (Prevnar13® ) |
N/A |
A substudy in the baricitinib rheumatoid arthritis phase 3 long-term extension clinical trial, RA-BEYOND, evaluated patient response to pneumococcal conjugate and tetanus toxoid vaccines while receiving baricitinib treatment for rheumatoid arthritis.6 One hundred six patients from the United States or Puerto Rico received baricitinib 2 mg or 4 mg treatment, out of whom 94 (89%) received concomitant methotrexate.6 More details here Vaccine study and here Substudy Results. Please see Response to pneumococcal vaccine and Safety Results for additional information. |
Tetanus vaccination Boostrix® (tetanus toxoid vaccine, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed) |
N/A |
A substudy has been conducted to evaluate the response to tetanus toxoid vaccines while receiving baricitinib for RA.6 More details here Vaccine study and here Substudy Results. Please see Response to tetanus vaccine and Safety Results for additional information. |
aAs recommendations regarding vaccination may vary, please follow local guidance and local labeling regarding the administration of vaccines, including the live attenuated and non-live HZ vaccines, to patients with autoimmune diseases.
Substudy evaluating patient response to pneumococcal and tetanus vaccinations
Vaccine study
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.6
One hundred six patients from the United States or Puerto Rico received baricitinib 2 mg or 4 mg treatment, out of whom 94 (89%) received concomitant methotrexate.6
The influence of baricitinib on the humoral response to non-live vaccines was evaluated in 106 rheumatoid arthritis (RA) patients (from the United States or Puerto Rico) under stable treatment with baricitinib 2 or 4 mg, receiving1,6
- 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 % (95 % CI: 58.4 %, 76.2 %) of the patients. In 43.1 % (95 % CI: 34 %, 52.8 %) of the patients, a satisfactory IgG immune response to tetanus vaccination was achieved.1
Substudy Results
Antibody immunglobulin G (IgG) concentrations were measured at prevaccination, and 5 and 12 weeks postvaccination.
Please find geometric mean concentrations of pneumococcal serotypes and tetanus antibodies in Geometric Mean Concentrations of Antibodies.6
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® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein)] was defined as a ≥2-fold increase in anti-pneumococcal antibody titers in ≥6/13 serotypes from baseline to 5 weeks post-vaccination.6,7
Of the 103 patients who completed the evaluations, a satisfactory humoral response was achieved by
Please find the humoral response by dose, age, corticosteroid use, and baseline Simplified Disease Activity Index (SDAI) in Patients Who Achieved Humoral Response at Week 5 Postvaccination by Subgroup.
Response to tetanus vaccine
A satisfactory humoral response to Boostrix® (tetanus toxoid vaccine, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed) 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.6,7
Of the 102 patients who completed the evaluations, a satisfactory humoral response was achieved by
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.6
Patients Who Achieved Humoral Response at Week 5 Postvaccination by Subgroup presents humoral response by dose, age, corticosteroid use, and baseline SDAI.
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.6
Additional Information From Professional Organizations
For current NICE guidance, please refer to 'COVID-19 rapid guideline: rheumatological autoimmune, inflammatory and metabolic bone disorders' www.nice.org.uk/guidance/ng167.
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.8,9 You may find direct links to each in the list of references.
Guidance for COVID-19 vaccine administration has also 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.
Guidance for COVID-19 vaccine administration has also been published by the
Vaccination Treatment Guidelines in Patients With Alopecia Areata
Recommendations for the use of COVID-19 vaccines in people with alopecia areata have been published by the
Expert opinions regarding the use of COVID-19 vaccines have also been referenced by the Canadian Alopecia Areata Foundation (CANAAF).
Vaccination Resources
Available vaccines and schedules by European country can be found on
- The European Vaccination Information Portal at https://vaccination-info.eu/en/vaccination
- 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.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3King B, Ohyama M, Kwon O, et al; BRAVE-AA Investigators. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(18):1687-1699. https://doi.org/10.1056/nejmoa2110343
4COVID-19 vaccine tracker and landscape. World Health Organization (WHO). March 30, 2023. Accessed November 1, 2023. https://cdn.who.int/media/docs/default-source/blue-print/17-jan-2023_novel-covid-19-vaccine-trackerbc492195-6466-473c-8fb5-9b68c8f77f1a.zip?sfvrsn=5c9e932d_11&download=true
5Vaccination Strategies. Centers for Disease Control. Updated April 1, 2024. Accessed April 15, 2024. https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html#anchor_1660077234206
6Winthrop 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
7Winthrop KL, Bingham CO, Bradley JD, 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 Rheumatol. 2017;69(suppl 10). American College of Rheumatology abstract 1824. 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/
8Furer 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
9Singh 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
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
Date of Last Review: 15 April 2024