Lupus Erythematosus, Discoid Clinical Trial
Official title:
Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with Higher Disease Activity (anti-dsDNA positive and low complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
Studies C1056 and C1057 followed very similar protocols, were of nearly identical design,
had common inclusion and exclusion criteria, and were conducted over the same time period.
Nevertheless, given the heterogeneous presentation of SLE disease and the fact that the
Phase III program was run globally, variation in the patient population, both within the
studies (e.g., between different centres) and between the studies (analogous to differences
between centres within the same study) should be expected.
Since it has been established that the conduct of the studies was effectively the same, it
then must be determined whether the relative treatment effect is different in one study
compared with the other study when evaluating whether two studies are similar enough to
pool. Each of these Phase III studies achieved statistical significance for belimumab 10
mg/kg on the pre-specified primary endpoint of SRI response at Week 52; therefore, these
nearly identical studies provide independent replication of results. While pooling is not
necessary to establish the effectiveness of belimumab, it was considered appropriate in
order to evaluate treatment effects in the high disease activity subgroup of interest, given
that the individual studies were not designed to provide sufficient power to demonstrate
effectiveness within subgroups. Thus, statistical evaluation pooling the studies and testing
for a treatment-by-study interaction was undertaken. A significant treatment-by-study
interaction would indicate that the relative treatment differences were statistically
different in the two studies and pooling would not be justified. Conversely, the lack of a
treatment-by-study interaction would indicate the studies resulted in a similar treatment
response and pooling would be justified.
When the two Phase III studies were pooled for the SRI analysis, the treatment-by-study
interaction was >0.5. Likewise, for the target population of high disease activity, the
treatment-by-study interaction was >0.7 suggesting that the high disease activity subgroup
may be more homogenous and therefore have a more similar treatment effect between the
studies than the population as a whole.
Given these considerations, it is reasonable and valid to pool the two studies and allows
better precision for evaluation of subgroups.
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