Apremilast (2) – Otezla®
Behçet's disease
Characteristics
| Start date | 15.05.2020 – Marketing authorisation: 08.04.2020 |
|---|---|
| Resolution | 05.11.2020 |
| INN | Apremilast |
| Brand name | Otezla® |
| Pharm. company | Amgen GmbH |
| G-BA Procedure ID | D-540 |
| ATC code | L04AA32 Selective immunosuppressants (L04AA) |
| ICD-10 codes (AIS) | M35.2Behçet´s disease |
| Alpha-ID codes (AIS) | I81367Behçet´s syndrome |
| DDD | 60 mg O |
| Therapeutic area | Other diseases Behçet's syndrome (BS) |
| Reason for procedure | New therapeutic indication |
| Specialty | Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with oral aphthae associated with Behçet's syndrome and for whom systemic therapy is an option | Therapy according to the physician's instructions. In addition to azathioprine, the medicinal products ciclosporin, colchicine, interferon-alpha and thalidomide as well as TNF-alpha inhibitors are also suitable comparators for the present benefit assessment in the context of therapy according to the physician's instructions. However, these medicinal products are not authorised in the present indication. |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + ITC (Bucher)) |
- Clinical trials
- The pharmaceutical manufacturer has submitted the RELIEF trial, on which the marketing authorisation is based, for the patient population under assessment. This trial compared apremilast (30 mg, taken orally twice daily) with placebo treatment over a period of 12 weeks.
- This study is a double-blind, parallel-group RCT comparing the treatment of Behçet’s syndrome with etanercept (25 mg, twice weekly as a subcutaneous injection) against placebo treatment.
- This study is a double-blind, parallel-group RCT comparing the treatment of Behçet’s syndrome-associated genital and oral aphthae with thalidomide (300 mg/day orally or 100 mg/day orally) against placebo treatment.
Adult patients with oral aphthae associated with Behçet’s syndrome who are eligible for systemic therapy
- For adult patients with oral aphthae associated with Behçet’s syndrome who are eligible for systemic therapy, the additional benefit of apremilast over the appropriate comparator therapy is not proven.
- morbidity
- The primary endpoint of the study was the area under the curve for the number of oral aphthae.
- Further endpoints included the number, response rate and pain levels associated with oral aphthae, the time to complete remission or to recurrence, and endpoints measuring disease activity.
- Overall assessment
- In its overall assessment, the G-BA therefore concludes that the additional benefit of apremilast over the appropriate comparator therapy is not proven.
- The results therefore do not allow for a comparison of the intervention under investigation with the appropriate comparator therapy.
- Furthermore, in the case of a chronic condition such as Behçet’s syndrome, a study duration of 24 weeks is generally considered necessary. The 12-week duration of the actively controlled study is therefore too short to establish any additional benefit.
- However, the identified studies are not suitable for an indirect comparison, either due to a very short study duration of 4 weeks or due to heterogeneous inclusion and exclusion criteria, as well as differing patient characteristics at the start of the study.
Courtesy translation only, please refer to the German original.
Associated procedures
| Apremilast (3) | Otezla® | Amgen GmbH | Moderate to severe plaque psoriasis; 6 to < 18 years of age | 360–430 | 100% additional benefit not proven | |
| Apremilast (2) | Otezla® | Amgen GmbH | Behçet's disease | 750–2,200 | 100% additional benefit not proven | |
| Apremilast (1) | Otezla® | Celgene GmbH | Plaque psoriasis (PP); Psoriatic arthritis (PA) | 50,800–140,500 | 100% additional benefit not proven |
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