Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Förändringar av kreatinfosfokinas

Det fanns inget som tydde på att behandling med Olumiant (baricitinib) ökade risken för allvarliga muskelrelaterade biverkningar.

Changes in Creatine Phosphokinase Levels Over Time

In 5 pooled phase 3 studies including extension data through 13 February 2018,

  • mean increases in CPK were mostly observed with BARI 4 mg from 0 to 8 weeks, and

  • mean CPK levels remained relatively stable at a higher level thereafter through 216 weeks.1

Treatment-Emergent Abnormal Creatine Phosphokinase Values

CPK increased > 5 x ULN is listed as an uncommon adverse event in the summary of product characteristics. 2

In controlled studies, for up to 16 weeks, increases in CPK values were common. Significant increases (> 5 x ULN) occurred in 0.8 % of patients treated with baricitinib and 0.3 % of patients treated with placebo. A dose relationship was observed with CPK elevations ≥ 5 x ULN of normal reported in 1.5 %, 0.8 % and 0.6 % of patients at 16 weeks in the 4 mg, 2 mg and placebo groups, respectively. Most cases were transient and did not require treatment discontinuation. In clinical trials, there were no confirmed cases of rhabdomyolysis. Elevations of CPK were observed at 4 weeks and remained stable at a higher value than baseline thereafter including in the long-term extension study.2

7-Study Placebo-Controlled Dataset

The proportions of patients with an increase in grade from <3 to ≥3 or from <4 to ≥4 were not statistically significantly different between the BARI 4-mg group and the placebo group.1 For additional details see Table 1.

4-Study Extended Dataset

The proportions of patients were not statistically different between the BARI 4-mg and 2-mg groups for categorical changes in CPK grade from

  • grade <3 to ≥3, and

  • grade <4 to ≥4.1

Data on the proportions of patients who reported categorical changes in CPK grade is provided in Table 1.

All BARI RA Dataset

For information on the proportions of patients with categorical changes in CPK grades in the All BARI RA analysis, see Table 1.

Table 1. Overview of CTCAE Grade Shifts in Creatine Phosphokinase1

 

Shift from:

Grade <1 to ≥1

n/NAR (%)

Shift from:

Grade <2 to ≥2

n/NAR (%)

Shift from:

Grade <3 to ≥3

n/NAR (%)

Shift from:

Grade <4 to ≥4

n/NAR (%)

7-Study Dataset Through 24 Weeks of Assigned Treatment

Placebo (N=1184)

93/1092 (8.5)

14/1164 (1.2)

5/1171 (0.4)

2/1173 (0.2)

BARI 4 mg (N=1111)

374/1035 (36.1)a

58/1094 (5.3) a

12/1100 (1.1)

6/1100 (0.5)

4-Study Extended Dataset

BARI 2 mg (N=479)

147/451 (32.6)

30/477 (6.3)

8/477 (1.7)

1/477 (0.2)

BARI 4 mg (N=479)

208/438 (47.5)b

63/470 (13.4)b

14/474 (3.0)

4/474 (0.8)

All BARI RA Dataset

All BARI RA (N=3770)

1817/3384 (53.7)

450/3550 (12.7)

111/3560 (3.1)

27/3564 (0.8)

Abbreviations: BARI = baricitinib; CTCAE = Common Terminology Criteria for Adverse Events; NAR = number of patients at risk for specified abnormality; RA = rheumatoid arthritis.

a p=.001; Difference between BARI 4 mg and placebo.

b p=.001; Difference between BARI 4 mg and BARI 2 mg.

Adverse Events Related to Elevated Creatine Phosphokinase

There was no evidence that BARI treatment increased the risk of serious muscle-related adverse events.1,3

Events Leading to Permanent Discontinuation of Study Treatment - All BARI RA

In the All BARI RA dataset with data through 13 February 2018, 6 patients (0.2%) permanently discontinued BARI treatment due to increased CPK.1

Additional Non-Serious Cases of Myopathy, Myositis, and Rhabdomyolysis - All BARI RA

In the All BARI RA dataset with data through 13 February 2018,

  • myopathy was reported by 6 (0.2%) patients

  • myositis was reported by 7 (0.2%) patients, and

  • rhabdomyolysis was reported by 2 (0.1%) patients.1

Indication

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.2

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.

References

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

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

3. Smolen JS, Genovese MC, Takeuchi T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment [published online September 15, 2018]. J Rheumatol. https://dx.doi.org/10.3899/jrheum.171361

Glossary

BARI = baricitinib

CPK = creatine phosphokinase

Datum fӧr senaste ӧversyn 2018 M10 02


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