Olumiant® ▼ (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Olumiant Summary of Product Characteristics (SmPC)

Olumiant® ▼ (baricitinib): Use of Vaccines with Baricitinib Treatment

The use of baricitinib with live vaccines is not recommended.

Use of Live Vaccinations with Baricitinib

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

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 at least 30 days prior to start of study medication.2

For further information please refer to “EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases”3 on the EULAR website (EULAR.org ).

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 program.2

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.

Substudy Evaluating Patient Response to Pneumococcal and Tetanus Vaccinations

A substudy in the BARI phase 3 long-term extension clinical trial, RA-BEYOND, evaluated patient response to pneumococcal conjugate and tetanus toxoid vaccines while receiving BARI treatment.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 pre-vaccination, and 5 and 12 weeks post-vaccination. Geometric mean concentrations of pneumococcal serotypes and tetanus antibodies are presented in Figure 1 .4

Figure 1. 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 12.2,4

Humoral response by dose, age, corticosteroid use, and baseline SDAI are presented in Table 1.

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 12.2,4

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 Table 1.

Table 1. Patients Who Achieved Humoral Response at Week 5 Post-Vaccination by Subgroupa4,5


Pneumococcal Vaccineb, n (%)

Tetanus Vaccinec, 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.

a A 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.

b Prevnar13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).

c Boostrix® (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

References

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

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

3. van Assen S, Agmon-Levin N, Elkayam O, et al. EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2011 Mar;70(3):414-22. http://ard.bmj.com/content/70/3/414.abstract

4. Winthrop 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

5. Winthrop 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/

Glossary

BARI = baricitinib

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

HZ = herpes zoster

Ig = immunoglobulin

JAK = Janus kinase

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

RA = rheumatoid arthritis

SDAI = Simplified Disease Activity Index

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.

Date of Last Review: April 30, 2019

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