Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Samtidigt användning av antivirala medel vid reumatoid artrit

I kliniska prövningar fick vissa av patienterna med reumatoid artrit som behandlades med baricitinib samtidigt antiviral behandling.

Summary

Concomitant use of antiviral treatments are not included in the drug-drug interaction information specific to BARI, and drug-drug interaction studies were not performed specifically for BARI and any antiviral therapies.1

Concomitant use of antiviral treatments was allowed in the RA phase 3 clinical studies. An analyses of efficacy and safety of BARI in combination with antiviral treatment in patients with RA has not been conducted.2 The proportion of patients receiving concomitant antiviral treatment is presented in  .

Potential Drug-Drug Interactions Based on Pharmacology/Pharmacokinetic Studies

Antiviral Treatments

Concomitant use of antiviral treatments are not included in the drug-drug interaction information specific to BARI, and drug-drug interaction studies were not performed specifically for BARI and any antiviral therapies.1

Drug-Drug Interaction Pharmacology Studies

Based on clinical pharmacology studies, no clinically relevant effects on BARI PK occurred when co-administered with

  • a CYP3A inhibitor

  • a CYP2C19/CYP2C9/CYP3A inhibitor

  • a CYP3A inducer, or

  • a Pgp inhibitor.1

Co-administration with BARI had no clinically relevant effects on the PK of,

  • a CYP3A substrate

  • a OATP1B1 substrate

  • a Pgp substrate, or

  • an OAT1, OAT3, and BCRP substrate.1,3

Concomitant Use With Antiviral Treatments in RA Phase 3 Clinical Trials

Concomitant use of antiviral treatments was allowed in the RA phase 3 clinical studies. An analyses of efficacy and safety of BARI in combination with antiviral treatment in patients with RA has not been conducted.2 The proportion of patients receiving concomitant antiviral treatment is presented in  .

Exclusion Criteria Related to Viral Infections

Patients were excluded from the RA phase 3 clinical trials if they have

  • active hepatitis B

  • active hepatitis C

  • symptomatic herpes zoster infection within 12 weeks prior to study entry, or

  • human immunodeficiency virus.2

Concomitant Antiviral Treatments by Study and Treatment Arm

The number of patients receiving concomitant antiviral treatments by study and treatment arm are provided in

Each of the 4 phase 3 studies in the clinical program evaluated a distinct treatment population of patients with moderate-to-severe RA.

  • RA-BEGIN compared BARI 4 mg monotherapy, BARI 4 mg plus MTX, and MTX monotherapy in patients who had limited or no prior treatment with MTX and were naïve to other DMARDs.4

The study population of DMARD-naïve patients from the RA-BEGIN study is not included in the approved label. However, the RA-BEGIN study is supportive for the target population of patients with an inadequate response to, or intolerance to, other DMARDs.3

Table 1. Concomitant Antiviral Therapies Administered for Rheumatoid Arthritis in Study RA-BEGIN2

ATC Level 2 Term
(Preferred Name)

MTX (N=210)
n (%)

BARI 4 mg (N=159)
n (%)

BARI 4 mg + MTX (N=215)
n (%)

Antivirals for systemic use

3 (1.4)

4 (2.5)

10 (4.7)

Aciclovir

2 (1.0)

1 (0.6)

4 (1.9)

Valaciclovir

1 (0.5)

2 (1.3)

3 (1.4)

Entecavir

0

0

1 (0.5)

Laninamivir

0

0

1 (0.5)

Oseltamivir

0

0

1 (0.5)

Famciclovir

1 (0.5)

1 (0.6)

0

Vidarabine

1 (0.5)

1 (0.6)

0

Abbreviations: ATC = Anatomical Therapeutic Chemical classification system; BARI = baricitinib; MTX = methotrexate.

Note: Preferred names were sorted within the ATC class by descending frequency in the BARI 4-mg + MTX group. The table includes data up to rescue from weeks 0 through 52 in the safety population.

  • RA-BEAM compared BARI 4 mg vs placebo or adalimumab, with background MTX, in patients with inadequate response to MTX.5 

Table 2. Concomitant Antiviral Therapies Administered for Rheumatoid Arthritis in RA-BEAM2

ATC Level 2 Term
(Preferred Name)

Placebo (N=488)
n (%)

BARI 4 mg (N=487)
n (%)

ADA (N=330)
n (%)

Antivirals for systemic use

8 (1.6)

26 (5.3)

9 (2.7)

Aciclovir

2 (0.4)

7 (1.4)

3 (0.9)

Laninamivir

0

5 (1.0)

0

Valaciclovir

3 (0.6)

5 (1.0)

4 (1.2)

Famciclovir

0

2 (0.4)

1 (0.3)

Inosine Pranobex

0

2 (0.4)

0

Oseltamivir

0

2 (0.4)

0

Vidarabine

0

2 (0.4)

0

Entecavir

0

1 (0.2)

0

Antivirals (non-specified)

1 (0.2)

1 (0.2)

0

Lysozyme

2 (0.4)

0

1 (0.3)

Abbreviations: ADA = adalimumab; ATC = Anatomical Therapeutic Chemical classification system; BARI = baricitinib.

Note: Preferred names were sorted within the ATC class by descending frequency in the BARI 4-mg group. The table includes data up to rescue or switch from weeks 0 through 52 in the safety population.

  • RA-BUILD compared BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in patients with inadequate response to csDMARDs.6

Table 3. Concomitant Antiviral Therapies Administered for Rheumatoid Arthritis in Study RA-BUILD2

ATC Level 2 Term (Preferred Name)

Placebo (N=228)
n (%)

BARI 2 mg (N=229)
n (%)

BARI 4 mg (N=227)
n (%)

Antivirals for systemic use

2 (0.9)

7 (3.1)

7 (3.1)

Aciclovir

1 (0.4)

2 (0.9)

3 (1.3)

Valaciclovir

0

3 (1.3)

3 (1.3)

Oseltamivir

1 (0.4)

2 (0.9)

1 (0.4)

Laninamivir

0

1 (0.4)

0

Abbreviations: ATC = Anatomical Therapeutic Chemical classification system; BARI = baricitinib.
Note: Preferred names were sorted within the ATC class by descending frequency in the BARI 4-mg group. The table includes data up to rescue from weeks 0 through 24 in the safety population.

  • RA-BEACON compared BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in patients with an inadequate response to at least one TNF inhibitor, who may also have had an inadequate response to one or more non-TNF inhibitor biologic DMARDs.7

Table 4. Concomitant Antiviral Therapies Administered for Rheumatoid Arthritis in Study RA-BEACON2

ATC Level 2 Term (Preferred Name)

Placebo (N=176)
n (%)

BARI 2 mg (N=174)
n (%)

BARI 4 mg (N=177)
n (%)

Antivirals for systemic use

4 (2.3)

5 (2.9)

11 (6.2)

Valaciclovir

0

3 (1.7)

5 (2.8)

Aciclovir

3 (1.7)

1 (0.6)

3 (1.7)

Brivudine

0

0

1 (0.6)

Famciclovir

1 (0.6)

0

1 (0.6)

Oseltamivir

0

1 (0.6)

1 (0.6)

Abbreviations: ATC = Anatomical Therapeutic Chemical classification system; BARI = baricitinib.
Note: Preferred names were sorted within the ATC class by descending frequency in the BARI 4-mg group. The table includes data up to rescue from weeks 0 through 24 in the safety population.

References

1. Payne C, Zhang X, Shahri N, et al. Evaluation of potential drug-drug interactions with baricitinib. Poster presented at: The Annual Meeting of the American Association of Pharmaceutical Scientists (AAPS); October 25-29, 2015; Orlando, FL.

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

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

4. Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib, methotrexate, or combination in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Rheumatol. 2017;69(3):506-517. http://dx.doi.org/10.1002/art.39953

5. Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376(7):652-662. http://dx.doi.org/10.1056/NEJMoa1608345

6. Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study [published correction appears in Ann Rheum Dis. 2017;76(9):1634. http://dx.doi.org/10.1136/annrheumdis-2016-210094corr1 ]. Ann Rheum Dis. 2017;76(1):88-95. http://dx.doi.org/10.1136/annrheumdis-2016-210094

7. Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374(13):1243-1252. http://dx.doi.org/10.1056/NEJMoa1507247

Glossary

BARI = baricitinib

BCRP = breast cancer resistance protein

csDMARD = conventional synthetic disease-modifying antirheumatic drug

CYP = cytochrome P450

DMARD = disease-modifying antirheumatic drug

MTX = methotrexate

OAT = organic anion transporter

Pgp = P-glycoprotein

RA = rheumatoid arthritis

TNF = tumor necrosis factor

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 M04 09


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