Secukinumab in psoriasis: now indication of added benefit for certain patients

Secukinumab (trade name: Cosentyx) has been approved since January 2015 for adults with moderate to severe plaque psoriasis. In the dossier assessment conducted by the German Institute for Quality and Efficiency in Health Care (IQWiG) in September 2015, no added benefit could be derived for secukinumab.

In an addendum, the Institute now examined data subsequently submitted by the manufacturer in the commenting procedure: This resulted in an indication of an added benefit for patients in whom other systemic treatments have been unsuccessful. The extent of the added benefit varies by the type of prior therapy, however: It is non-quantifiable when biologics have been used, and minor without Prior therapy with biologics. There were still no suitable data for patients who are candidates for other systemic treatments.

Results after 52 weeks available

The dossier had already contained results of a randomized controlled trial in which patients for whom systemic treatment was not an option had been treated either with secukinumab or with ustekinumab. This was only an interim analysis after 24 weeks, however; the study had not been completed at this time point. For some outcomes, no relevant differences between the study arms had been shown; whereas for others, these were not interpretable because of the short duration.

In the commenting procedure at the Federal Joint Committee (G-BA), the manufacturer submitted the results of the study that had been completed after 52 weeks as planned.

Remission: relevant differences in favour of secukinumab

In contrast to the data from the dossier, the analyses after 52 weeks showed a relevant difference in favour of secukinumab for the outcome “remission” (complete disappearance of psoriasis). However, these data also suggested that the symptoms had reappeared in a large proportion of the patients. No analyses were available that considered the duration of remission. It is not assumed, however, that secukinumab has no advantage in comparison with ustekinumab in this outcome. IQWiG therefore assumes at least a hint of an added benefit.

Prior therapy with biologics affects treatment success

If the change in symptoms is considered individually, it can be seen that the type of prior therapy affects treatment success: There was better relief of pain, itching and scaling in the secukinumab arm of the study than in the ustekinumab arm. This was only the case, however, in patients who had received (unsuccessful) prior therapy with biologics. IQWiG found an indication of an added benefit in each case.

Advantage also in quality of life

Whereas the dossier had only contained analyses at the time point 16 weeks on health-related quality of life, the manufacturer now subsequently submitted the data after completion of the study, i.e. after 52 weeks. Here the results under secukinumab were also better than under the comparator therapy, from which IQWiG derived an indication of an added benefit for the outcome “quality of life”.

Regarding side effects (adverse events and treatment discontinuation due to adverse events), the data showed no relevant differences between the study arms, i.e. secukinumab had no greater or lesser harm than ustekinumab.

Extent of added benefit partly non-quantifiable

Hence overall, only positive effects of secukinumab remain for psoriasis patients for whom other systemic treatments are not an option. However, there are differences in the certainty of conclusions (hint or indication) and in the extent: There is an indication of a minor added benefit for all patients who have not been pretreated with biologics. For patients pretreated with biologics, there is also indication, but the extent of the added benefit is non-quantifiable, i.e. it might be “minor”, “considerable” or even “major”.

For patients who are candidates for another systemic treatment, however, there is still no hint of an added benefit because suitable data for the assessment are still missing.

G-BA decides on the extent of added benefit

The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the manufacturer’s dossier and the IQWiG dossier assessment, the manufacturer submitted additional information in the commenting procedure. The G-BA subsequently commissioned IQWiG to assess the data subsequently submitted. IQWiG now presents this assessment in the form of an addendum. The G-BA makes a final decision on the extent of added benefit.