Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Olumiant® ▼ (baricitinib): Säkerhet hos äldre vid reumatoid artrit

Baricitinib kan användas till patienter ≥65. Hos patienter ≥75 är en startdos på 2 mg lämplig.

Short summary

  • Age ≥ 65 years or ≥ 75 years has no effect on baricitinib exposure (Cmax and AUC).1

  • Clinical experience in patients ≥75 years is very limited and in these patients a starting dose of 2 mg is appropriate.1

  • In a post hoc analysis of 2 pooled phase 3 clinical trials, more AEs were reported in the elderly.2

  • Proportions of patients ≥65 years of age and <65 years of age who reported AEs or SAEs or discontinued from the study due to an AE were similar in the BARI 4-mg and placebo groups.3

  • Serious infections by age <65 and ≥ 65 years old are presented in Figure 1.

Post Hoc Subgroup Analysis of Pooled RA-BEAM and RA-BUILD: Effect of Age on Safety

Overview of Pooled Analysis

A post hoc analysis of data from RA-BEAM and RA-BUILD was conducted to evaluate the efficacy and safety of using BARI in the elderly subpopulation, defined as patients 65 years or older. Combined data from both trials provided an overall sample of

  • 714 patients in the BARI 4-mg group, and

  • 716 patients in the placebo group.2

Safety data are presented for patients aged <50, ≥50 and <65 years, and ≥65 years.2

Safety Results

In both the BARI 4-mg and placebo groups, elderly patients had more AEs, serious AEs, and discontinuations due to AEs at week 24 (Table 1).2

Table 1. Safety Outcomes in the Elderly Population Compared to Younger Patients at Week 24 in RA-BUILD and RA-BEAM2


Baricitinib 4 mg

<50 years
(n=259)

Baricitinib 4 mg

50 and <65 years
(n=319)

Baricitinib 4 mg

65 years
(n=136)

Placebo

<50 years
(n=254)

Placebo

50 and <65 years
(n=349)

Placebo

65 years
(n=113)

Patients with ≥1 AE, n (%)

229 (88)

296 (93)

135 (99)

212 (84)

326 (93)

111 (98)

Discontinuation due to AE or death, n (%)

6 (2)

18 (6)

12 (9)

6 (2)

14 (4)

7 (6)

Death, n (%)

0

1 (<1)

1 (1)

0

2 (1)

0

Serious AEs, n (%)

8 (3)

15 (5)

12 (9)

10 (4)

11 (3)

12 (11)

Serious infections, n (%)

3 (1)

2 (1)

4 (3)

4 (2)

5 (1)

2 (2)

Cardiac disorders, n (%)

0

2 (1)

2 (2)

1 (<1)

1 (<1)

2 (2)

Patients with ≥1 infection, n (%)

99 (38)

125 (39)

48 (35)

89 (35)

86 (25)

38 (34)

Herpes zoster, n (%)

2 (1)

5 (2)

3 (2)

0

2 (1)

0

Abbreviation: AE = adverse event. 

Serious AEs requiring hospitalization were reported in

  • 1 patient due to thrombophlebitis in the BARI 4-mg <50-year age group, and

  • 6 patients due to fractures related to falls with 2 in the ≥65-year age group.2

None of these patients discontinued the study, and all of these events resolved.2

There were 4 deaths in patients ≥50 years of age due to

  • subarachnoid hemorrhage and renal failure in the placebo ≥50 and <65 group (n=2)

  • circulatory failure in the BARI 4-mg ≥50 and <65 group (n=1), and

  • pneumonia in the BARI 4-mg elderly group (n=1).2

Post Hoc Subgroup Analysis of Pooled RA-BEAM and RA-BUILD: Effect of Baseline Demographics on safety

Overview of Post Hoc Analysis

This post hoc analysis assessed the effect of baseline demographics, including age, on the response to BARI treatment in patients with RA and an inadequate response to prior csDMARDs.3

Data was pooled from 2 phase 3 double-blind, randomized controlled trials for

  • 714 patients who received BARI 4 mg, and

  • 716 patients who received placebo.3

Safety Results

The proportions of patients ≥65 years of age and <65 years of age who reported AEs or SAEs or discontinued from the study due to an AE were similar in the BARI 4-mg and placebo groups.3

Integrated Safety Dataset Analysis of Serious Infections Based on Age

Dataset Descriptions

7-Study Placebo-Controlled Dataset

The 7-study pooled dataset included patients with RA randomized to BARI 4 mg (N=1142, PYE=471.8) or placebo (N=1215, PYE=450.8) from 3 phase 2 studies and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON and RA-BALANCE). Patients in the placebo group could have been taking background MTX or other conventional DMARDs. Evaluation time periods included through

  • the 12-week placebo-controlled period in phase 2 studies

  • 16 weeks of assigned treatment before any opportunity for rescue therapy in phase 3 studies, and

  • 24 weeks of assigned treatment or until rescue in phase 3 studies.4

Data from BARI 2 mg (N=479, PYE=185.8) is derived from 4 of these studies in which both BARI 2 mg and BARI 4 mg were options during randomization (2 phase 2 studies as well as RA-BUILD and RA-BEACON).4

All BARI RA Dataset

The All BARI RA analysis set included 3770 patients with RA who received BARI at a variety of doses from 1 phase 1, 3 phase 2, and 5 phase 3 studies (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, RA-BALANCE). Data includes a long-term extension study (RA-BEYOND) with

  • 13,148 PYE,

  • median exposure of 4.2 years,

  • maximum exposure of 8.4 years, and

  • data through 01 September 2019.5,6

Serious Infection Results Based on Age

Results from this study specifically related to serious infections by age <65 and ≥65 years are presented in Figure 1. Regardless of age, the rate of serious infections was comparable between both the BARI and placebo groups, although patients ≥65 years had higher IRs than those <65 years.6

Figure 1. Serious Infection by Age Group6

Abbreviations: BARI = baricitinib; IR = incidence rate; PBO = placebo; PYE = patient-years exposure; RA = rheumatoid arthritis.

Note: Maximum exposure of 8.4 years and data through 01 September 2019.

Information From the Label

Clinical experience in patients ≥ 75 years is very limited and in these patients a starting dose of 2 mg is appropriate.1

The recommended dose of baricitinib is 4 mg once daily.1 

A dose of 2 mg once daily

  • is appropriate for patients such as those aged ≥ 75 years and

  • may be appropriate for patients with a history of chronic or recurrent infections.1

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies. In rheumatoid arthritis clinical studies, herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and conventional DMARDs.1

If a patient develops herpes zoster, baricitinib treatment should be temporarily interrupted until the episode resolves.1

Age ≥ 65 years or ≥ 75 years has no effect on baricitinib exposure (Cmax and AUC).1

References

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

2. Fleischmann R, Alam J, Arora V, et al. Safety and efficacy of baricitinib in elderly patients with rheumatoid arthritis. RMD Open. 2017;3(2):1-5. http://dx.doi.org/10.1136/rmdopen-2017-000546

3. Kremer JM, Schiff M, Muram D, et al. Response to baricitinib therapy in patients with rheumatoid arthritis with inadequate response to csDMARDs as a function of baseline characteristics. RMD Open. 2018;4(1):e000581. http://dx.doi.org/10.1136/rmdopen-2017-000581

4. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis over a median of 3 years of treatment: an updated integrated safety analysis. Lancet Rheumatol. 2020;2(6):E347-E357. https://doi.org/10.1016/S2665-9913(20)30032-1

5. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis [abstract]. Ann Rheum Dis. 2020;79(suppl 1):638. https://ard.bmj.com/content/79/Suppl_1/642.1

6. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis. Poster presented at: European League Against Rheumatism Virtual Congress; June 3-6, 2020.

Glossary

AE = adverse event

BARI = baricitinib

BMI = body mass index

csDMARD = conventional synthetic disease-modifying antirheumatic drug

PYE = patient-years of exposure

RA = rheumatoid arthritis

SAE = serious adverse event

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 14


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Klicka för att chatta är tillgänglig

Klicka för att chatta är offline

Skriv din fråga till oss