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Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis -

Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis -

1266

The breakdown of patient backgrounds was 13.6% male, 86.4% female, and the average age was 69.8 years old. Complications included renal disease and hepatic disease in 5.2%, and 5.7% of patients, respectively. The duration of rheumatoid arthritis was <2 years in 15.6% of patients, >=2 to <10 years in 40.6% of patients, and >=10 years in 43.8% of patients.

Overall, 1,266 Japanese patients with RA were registered in this study, and case report forms were collected from 1,253 patients. In total, 1,239 patients were included in the safety analysis set and 815 patients were included in the effectiveness analysis set.

The incidence of adverse drug reactions (ADRs) in the safety analysis set was 3.0%. The most common ADRs were hypocalcaemia (1.2%) and ONJ (0.5%); all the other ADRs were reported in one patient each (0.1%).

[Safety] (For the incidence of ADRs, refer to the "Adverse events" section.) As a result of univariate and multivariate analyses, a history of any drug allergy and DAS28-CRP disease activity at baseline were statistically significant risk factors associated with the occurrence of ADRs. Thus, ADRs such as prurigo, rash, injection site erythema and nasopharyngitis may be attributed to patient characteristics rather than to denosumab administration, since they only occurred in patients with a history of any drug allergy. Data on DAS28-CRP disease activity at baseline were unknown for some patients, and it was noted that the number of cases in each DAS28-CRP disease severity category was small, which may have affected the statistical significance of the finding. There was no consistent trend in the severity of DAS28-CRP disease activity and incidence of ADRs, and it was not possible to accurately determine the effects of exposure to denosumab. [Effectiveness] The incidence of progression of bone erosion was 8.7% in patients included in the effectiveness analysis set (n=71/815). As a result of univariate and multivariate analyses, DAS28-ESR disease activity and Steinbrocker stage at baseline, prior use of biologicals and initial steroid dose were statistically significant risk factors associated with the progression of bone erosion in this study. Since patients with these baseline clinical and treatment characteristics represent a population with moderate-to-severe RA, our results suggest that the effectiveness of denosumab in inhibiting bone erosion progression may be attenuated in a patient population with high disease activity. Since the extent of bone erosion progression for these subgroups ranged from 10.2% to 25.9%, and a certain suppressive effect of bone erosion progression can be expected, the results do not raise any new clinical concerns.

(Described in the "Primary Outcome Measures" section.)

This observational cohort study in Japanese patients with RA demonstrated that denosumab was well tolerated and showed effectiveness during long-term treatment in routine clinical practice. No new safety concerns were identified, and denosumab treatment effectively reduced the rate of progression of bone erosion, indicating that denosumab showed effectiveness as a treatment option in patients with RA who have experienced progression of bone erosion during treatment with DMARDs.

No

DAIICHI SANKYO Co.,Ltd.

3-5-1,Nihonbashi Honcho,Chuo-Ku,Tokyo

contact_gpsp@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

3-5-1,Nihonbashi Honcho,Chuo-Ku,Tokyo

+81-3-6225-1059

completed

Observational

Postmarketing surveillance

treatment purpose

N/A

RA patients who receive PRALIA for the first time

Those who previously used PRALIA for osteoporosis treatment

Both

Rheumatoid Arthritis

investigational material(s)
Generic name etc : PRALIA 60 mg Subcutaneous Injection Syringe(denosumab)
INN of investigational material : denosumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

efficacy
safety
1.Safety
- Incidence by adverse drug reactions/infection type
- Incidence of serious adverse events
- Safety profile in the patients with PRALIA administration changed to once every 3 months
2.Efficacy
- Radiographic assessment of bone erosion progression

other
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