Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Påbörjad förbättring av sjukdomsaktivitet

Tidiga förbättringar av tecken och symptom, fysisk funktion och sjukdomsaktivitet observerades i baricitinib-behandlade grupper så tidigt som vecka 1 och upprätthölls till slutet av studien.

Information from the label

Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate.1

In all studies, patients treated with baricitinib 4 mg once daily had statistically significantly higher ACR20, ACR50 and ACR70 response at 12 weeks compared to placebo, MTX or adalimumab. Time to onset of efficacy was rapid across measures with significantly greater responses seen as early as week 1. Continued, durable response rates were observed, with ACR20/50/70 responses maintained for at least 2 years including the long-term extension study.1

Differences in efficacy between the 4 mg and the 2 mg doses were most notable in the bDMARD-IR population (RA-BEACON), in which statistically significant improvements in the ACR components of swollen joint count, tender joint count and ESR were shown for baricitinib 4 mg compared to placebo at Week 24 but not for baricitinib 2 mg compared to placebo. In addition, for both study RA-BEACON and RA-BUILD, onset of efficacy was faster and the effect size was generally larger for the 4 mg dose groups compared to 2 mg.1

Baricitinib Clinical Trial Program

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.2

  • RA-BEAM compared BARI 4 mg vs placebo or adalimumab, with background MTX, in patients with inadequate response to MTX.3 

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

  • 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.5

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.1

RA-BEGIN Onset of Efficacy

Compared with MTX monotherapy, statistically significant improvements for the BARI 4 mg monotherapy and BARI 4 mg plus MTX groups were observed in

  • the proportion of patients achieving ACR20 response observed at week 1 and maintained through the primary endpoint at week 24 and through the end of study treatment at week 52 (Figure 1)

  • change from baseline in HAQ-DI score observed at week 1 and maintained through weeks 24 and 52 (Figure 2), and

  • change from baseline in DAS28-hsCRP observed at week 1 and maintained through weeks 24 and 52 (Figure 3).2

RA-BEAM Onset of Efficacy

Baricitinib 4 mg vs Placebo

Compared with placebo, statistically significant improvements for the BARI 4-mg group were observed in

  • the proportion of patients achieving ACR20 response observed at week 1 and maintained through the primary endpoint at week 12 and through end of the controlled period at week 24 (Figure 1),

  • change from baseline in HAQ-DI score observed at week 1 and maintained through weeks 12 and 24 (Figure 2), and

  • change from baseline in DAS28-hsCRP observed at week 1 and maintained through weeks 12 and week 24 (Figure 3).3

Baricitinib 4 mg vs Adalimumab 40 mg

Compared with adalimumab, significant improvements for the BARI 4-mg group were observed in

  • the proportion of patients achieving ACR20 response observed at week 12 and weeks 20 through 52 (Figure 1)

  • change from baseline in HAQ-DI score observed at week 4 and maintained through week 52 (Figure 2), and

  • change from baseline in DAS28-hsCRP observed at week 1 and weeks 8 through 52 (Figure 3).3

RA-BUILD Onset of Efficacy

Compared with placebo, statistically significant improvements for the BARI 4-mg and 2-mg groups were observed in

  • the proportion of patients achieving ACR20 response observed at week 1 and maintained through the primary endpoint at week 12 and through the end of study treatment at week 24 (Figure 1)

  • change from baseline in HAQ-DI score observed at week 1 in the BARI 4-mg group (week 8 in the BARI 2-mg group) and maintained through weeks 12 and 24 (Figure 2), and

  • change from baseline in DAS28-hsCRP observed at week 1 and maintained through weeks 12 and 24 (Figure 3).4

RA-BEACON Onset of Efficacy

Compared with placebo, statistically significant improvements for the BARI 4-mg and 2-mg groups were observed in

  • the proportion of patients achieving ACR20 response observed at week 1 and maintained through the primary endpoint at week 12 and through the end of study treatment at week 24 (Figure 1)

  • change from baseline in HAQ-DI score observed at week 1 and at weeks 12 through 24 (Figure 2), and

  • change from baseline in DAS28-hsCRP observed at week 1 and maintained through weeks 12 and 24 (Figure 3).5

Figure 1. Proportions of Patients Achieving ACR20 Response Over Time2-5  

Abbreviations: ACR20 = American College of Rheumatology 20% response criteria; MTX = methotrexate; NRI = non-responder imputation.

P value vs Placebo (or MTX in RA-BEGIN):
* p≤.05.
** p≤.01.
*** p≤.001.
P value vs Adalimumab:
+ p≤.05.
++ p≤.01.
+++ p≤.001.

Figure 2. Changes in Patient-Reported Physical Function (HAQ-DI) Over Time2-5

Abbreviations: HAQ-DI = Health Assessment Questionnaire-Disability Index; LS = least squares; MTX = methotrexate.

P value vs Placebo (or MTX in RA-BEGIN):
* p≤.05.
** p≤.01.
*** p≤.001.
P value vs Adalimumab:
+ p≤.05.
++ p≤.01.

Figure 3. Changes in Disease Activity (DAS28-hsCRP) over time2-5

Abbreviations: DAS28-hsCRP = 28-joint Disease Activity Score based on high-sensitivity C-reactive protein; LS = least squares; MTX = methotrexate.

P value vs Placebo (or MTX in RA-BEGIN):
*** p≤.001.
P value vs Adalimumab:
+ p≤.05.
++ p≤.01.
+++ p≤.001.

References

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

2. 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

3. 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

4. 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

5. 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

ACR20 = 20% improvement in American College of Rheumatology criteria

BARI = baricitinib

csDMARD = conventional synthetic disease-modifying antirheumatic drug

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

DMARD = disease-modifying antirheumatic drug

HAQ-DI = Health Assessment Questionnaire-Disability Index

MTX = methotrexate

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 M01 16


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