Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Jämförelse av baricitinib och filgotinib kliniska fas 3 utvecklingsprogram i reumatoid artrit

Trots att fas 3 reumatoid artrit-kliniska utvecklingsprogram genomfördes för både baricitinib och filgotinib, har ingen studie som direkt jämfört de två molekylerna genomförts.

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Phase 3 Rheumatoid Arthritis Clinical Development Program for Baricitinib and Filgotinib

The phase 3 clinical development programs for BARI and filgotinib included patients with moderately to severely active RA who had inadequate responses to treatment with MTX and bDMARDs or who were MTX naïve. However, there were differences in the patient populations evaluated and study designs in these clinical development programs.1-5 Therefore, no efficacy and safety comparative conclusions can be drawn by indirectly comparing the results of these programs.

Methotrexate-Naïve Patients

The phase 3 RA clinical development programs for both BARI and filgotinib included studies in MTX-naïve patients.2,5

In the BARI program, RA-BEGIN was conducted in patients who were DMARD naïve and it compared

  • BARI monotherapy
  • dose-titrated MTX monotherapy, and
  • BARI plus MTX.2

In the filgotinib program, FINCH3 was conducted in patients who were MTX naïve and it compared

  • filgotinib monotherapy
  • MTX monotherapy, and
  • filgotinib plus MTX.5

Thus, the BARI phase 3 RA clinical program evaluated treatment in patients who were DMARD naïve, not just MTX naïve.2,6

Baricitinib and Filgotinib Phase 3 Clinical Trial Designs in Treatment-Naïve Patients2,5

 

BARI
RA-BEGIN

Filgotinib
FINCH3

Patient population

DMARD naïve

MTX naïve

Treatment arms




BARI 4 mg mono (n=159)

FIL 200 mg mono (n=210)

BARI + MTX (n=215)

FIL 200 mg + MTX (n=416)

FIL 100 mg + MTX (n=207)

MTX mono (n=210)

MTX mono (n=416)

Background DMARDs

None

None

Duration

52 weeks

52 weeks

Primary endpoint

ACR20 at week 24

ACR20 at week 24

Secondary endpoints

mTSS and SDAI ≤3.3

ACR50, ACR70, DAS28-CRP ≤3.2 and <2.6, mTSS, HAQ-DI, SF-36 PCS, and FACIT-Fatigue

Abbreviations: ACR20 = 20% improvement in American College of Rheumatology criteria; ACR50 = 50% improvement in American College of Rheumatology criteria; ACR70 = 70% improvement in American College of Rheumatology criteria; BARI = baricitinib; DAS28-CRP = Disease Activity Score based on C-reactive protein; DMARD = disease-modifying antirheumatic drug; FACIT = Functional Assessment of Chronic Illness Therapy; FIL = filgotinib; HAQ-DI = Health Assessment Questionnaire-Disability Index; mono = monotherapy; mTSS = modified Total Sharp Score; MTX = methotrexate; SDAI = Simplified Disease Activity Index; SF-36 PCS = Short-Form 36 Physical Component Summary.

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.7

Methotrexate Inadequate Responders

The phase 3 RA clinical development programs for both BARI and filgotinib included studies in MTX-IR patients with ADA as a treatment arm.1,3

In the BARI program, RA-BEAM was statistically powered to make both non-inferiority and superiority assessments between BARI and ADA for ACR20 and superiority assessments for DAS28-hsCRP.1

In the filgotinib program, FINCH1 was statistically powered to test non-inferiority between filgotinib and ADA for DAS28-CRP ≤3.2 and <2.6.3

Baricitinib and Filgotinib Phase 3 Active Comparator Clinical Trial Designs in Patients With Inadequate Response to Methotrexate1,3

 

BARI
RA-BEAM

Filgotinib
FINCH1

Patient population

MTX-IR

MTX-IR

Treatment arms




BARI 4 mg (n=487)

FIL 100 mg (n=480)

FIL 200 mg (n=475)

ADA (n=330)

ADA (n=325)

PBO (n=488)

PBO (n=475)

Background DMARDs

MTX

MTX

Duration

52 weeks

52 weeks

Primary endpoint

ACR20 at week 12

ACR20 at week 12

Secondary endpoints

HAQ-DI, DAS28-CRP ≤3.2, mTSS

ACR50, ACR70, DAS28-CRP ≤3.2 and <2.6, mTSS, HAQ-DI, SF-36 PCS, and FACIT-Fatigue

Abbreviations: ACR20 = 20% improvement in American College of Rheumatology criteria; ACR50 = 50% improvement in American College of Rheumatology criteria; ACR70 = 70% improvement in American College of Rheumatology criteria; ADA = adalimumab; BARI = baricitinib; DAS28-CRP = Disease Activity Score based on C-reactive protein; DMARD = disease-modifying antirheumatic drug; FACIT = Functional Assessment of Chronic Illness Therapy; FIL = filgotinib; HAQ-DI = Health Assessment Questionnaire-Disability Index; IR = inadequate response; mono = monotherapy; mTSS = modified Total Sharp Score; MTX = methotrexate; PBO = placebo; SF-36 PCS = Short-Form 36 Physical Component Summary.

Biologic DMARD Inadequate Responders

The phase 3 RA clinical development programs for both BARI and filgotinib included studies in bDMARD-IR patients.4,8

In the BARI RA-BEACON study, more than half of the patients had previously failed more than 1 bDMARD.8

In the filgotinib FINCH2 study, 44-51% of the patients had previously failed more than 1 bDMARD.4

Baricitinib and Filgotinib Phase 3 Clinical Trial Designs in Patients With Inadequate Response to bDMARDs4,8

 

BARI
RA-BEACON

Filgotinib
FINCH2

Patient population

TNFi-IR

bDMARD-IR

Treatment arms




BARI 2 mg (n=174)

FIL 100 mg (n=153)

BARI 4 mg (n=177)

FIL 200 mg (n=148)

PBO (n=176)

PBO (n=148)

Background DMARDs

csDMARDs

csDMARDs

Duration

24 weeks

24 weeks

Primary endpoint

ACR20 at week 12

ACR20 at week 12

Secondary endpoints

HAQ-DI, DAS28-CRP, and SDAI ≤3.3

HAQ-DI, DAS28-CRP ≤3.2 and <2.6, SF-36 PCS, and FACIT-Fatigue

Abbreviations: ACR20 = 20% improvement in American College of Rheumatology criteria; BARI = baricitinib; bDMARD = biologic disease-modifying antirheumatic drug; csDMARD = conventional synthetic disease-modifying antirheumatic drug; DAS28-CRP = Disease Activity Score based on C-reactive protein; DMARD = disease-modifying antirheumatic drug; FACIT = Functional Assessment of Chronic Illness Therapy; FIL = filgotinib; HAQ-DI = Health Assessment Questionnaire-Disability Index; IR = inadequate response; PBO = placebo; SDAI = Simplified Disease Activity Index; SF-36 PCS = Short-Form 36 Physical Component Summary; TNFi = tumor necrosis factor inhibitor.

References

1Taylor 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

2Fleischmann 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

3Combe B, Kivitz A, Tanaka Y, et al. LB0001 efficacy and safety of filgotinib for patients with rheumatoid arthritis with inadequate response to methotrexate: FINCH1 primary outcome results. Ann Rheum Dis. 2019;78(suppl 2):77-78. European League Against Rheumatism abstract LB0001. http://dx.doi.org/10.1136/annrheumdis-2019-eular.8676

4Genovese MC, Kalunian K, Gottenberg JE, et al. Effect of filgotinib vs placebo on clinical response in patients with moderate to severe rheumatoid arthritis refractory to disease-modifying antirheumatic drug therapy: The FINCH 2 randomized clinical trial. JAMA. 2019;322(4):315-325. http://dx.doi.org/10.1001/jama.2019.9055

5Westhovens R, Rigby W, van der Heijde D, et al. LB0003 efficacy and safety of filgotinib for patients with rheumatoid arthritis naïve to methotrexate therapy: FINCH3 primary outcome results. Ann Rheum Dis. 2019;78(suppl 2):259-261. European League Against Rheumatism abstract LB0003. http://dx.doi.org/10.1136/annrheumdis-2019-eular.8678

6Filgotinib alone and in combination with methotrexate (MTX) in adults with moderately to severely active rheumatoid arthritis who are naive to MTX therapy (FINCH 3). ClinicalTrials.gov identifier: NCT02886728. Updated October 8, 2019. Accessed September 23, 2020. https://clinicaltrials.gov/show/NCT02886728

7Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

8Genovese 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

ACR20 = 20% improvement in American College of Rheumatology criteria

ADA = adalimumab

BARI = baricitinib

bDMARD = biologic disease-modifying antirheumatic drug

bDMARD-IR = inadequate response or intolerant to biologic disease-modifying antirheumatic drug treatment

DAS28-hsCRP = Disease Activity Score based on high-sensitivity C-reactive protein

DMARD = disease-modifying antirheumatic drug

MTX = methotrexate

MTX-IR = inadequate response to methotrexate

RA = rheumatoid arthritis

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 M09 22


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