miércoles, 19 de abril de 2017

OCREVUS: New Drug Trials Snapshot Posted

Drug Approvals and Databases > Drug Trials Snapshots: OCREVUS



FDA Logo
A new DRUG TRIALS SNAPSHOT is now available.
OCREVUS is used for the treatment of patients with two types of multiple sclerosis (MS):
  • relapsing forms of multiple sclerosis (RMS)
  • primary progressive multiple sclerosis (PPMS).
In RMS patients have episodes of worsening function (relapses) followed by recovery periods. In PPMS patients have steadily worsening function from the onset of symptoms.
See more Drug Trial Snapshots or contact us with questions at Snapshots@fda.hhs.gov.

OCREVUS (ocrelizumab)
(ok’re vus)
Genentech
Approval date: March 28, 2017

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

OCREVUS is used for the treatment of patients with two types of multiple sclerosis (MS):
  • relapsing forms of multiple sclerosis (RMS)
  • primary progressive multiple sclerosis (PPMS).
In RMS patients have episodes of worsening function (relapses) followed by recovery periods. In PPMS patients have steadily worsening function from the onset of symptoms.

How is this drug used?

OCREVUS is given by a healthcare provider using a needle placed in a vein (known as intravenous infusion). The first two infusions are given 2 weeks apart followed by an infusion every 6 months. Before each infusion, patients should receive medicines to reduce the risk of infusion related allergic reactions.

What are the benefits of this drug?

Patients with RMS who received OCREVUS showed less frequent relapses in comparison to patients who received another MS drug, Rebif. Patients with PPMS who received OCREVUS experienced a longer period of time before worsening function compared to patients who received placebo.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: OCREVUS worked similarly in men and women with RMS, but better in men with PPMS.
  • Race: Most of the patients were White. The number of patients of other races was limited; therefore differences in response to OCREVUS among races could not be determined.
  • Age: OCREVUS worked similarly in age groups studied. The number of patients above 65 years of age was limited, however, so that differences in response between patients above and below 65 years of age could not be determined.

What are the possible side effects?

OCREVUS may frequently cause infusion reactions, some of which can be severe causing rash, itching, trouble breathing, or fall in blood pressure. In trials of OCREVUS, about 35-40% of patients experienced an infusion reaction after being given a corticosteroid and an antihistamine with the infusion. This reduced the severity of the infusion reactions, but they still occurred.
Other serious side effects of OCREVUS are increased risk of infections and increased risk of cancers.
Apart from infusion reactions, the most common side effects of OCREVUS are upper and lower respiratory infections and skin infections.

Were there any differences in side effects among sex, race and age?

  • Sex: The risk of side effects was similar in in men and women.
  • Race: Majority of the patients were White. The number of patients in other races was limited; therefore differences in side effects among races could not be determined.
  • Age: The risk of side effects was similar in age groups studied. The number of patients above 65 years of age was limited; therefore, differences in response between patients above and below 65 years of age could not be determined.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved OCREVUS based on evidence from three clinical trials of patients with MS.
Two trials (Trials 1 and 2) enrolled total of 1656 patients with RMS in US, Canada, European countries, Latin America, Africa and Australia. They compared OCREVUS to Rebif.
One trial (Trial 3) enrolled total of 732 patients with PPMS in USA, Canada and European countries. This trial compared OCREVUS to placebo.
These two groups of patients will be presented separately.
The figure below summarizes how many men and women were enrolled in Clinical Trials 1 and 2.
Figure 1. Baseline Demographics by Sex (Trials 1 and 2 combined)
Pie chart summarizing how many men and women were in the clinical trials 1 and 2 of the drug OCREVUS. In total, 563 men (34%) and 1093 women (66%) participated in the clinical trials.
Adapted from FDA Clinical review
Figure 2. Baseline Demographics by Sex (Trial 3)
Figure 2. Baseline Demographics by Sex OCREVUS
Adapted from FDA Clinical review
Figure 3 and Table 1 below summarize the percentage of patients by race in Clinical Trials 1 and 2 combined.
Figure 3. Baseline Demographics by Race (Trials 1 and 2 combined)
Pie chart summarizing the percentage of patients by race in OCREVUS clinical trials 1 and 2. In total, 1500 Whites (91%), 72 Black or African Americans (4%) and 84 all  Others (5%), participated in the clinical trials.
Adapted from FDA Clinical review
Table 1. Baseline Demographics by Race
RaceNumber of PatientsPercentage
White150091
Black or African American724
Other845
Adapted from FDA Clinical review
Figure 4 and Table 2 below summarize the percentage of patients by race in Clinical Trial 3.
Figure 4. Baseline Demographics by Race (Trial 3)
Pie chart summarizing the percentage of patients by race in OCREVUS clinical trial 3. In total, 689 Whites (94%), 14 Black or African Americans (2%), 5 American Indian or Alaska Native (1%) and 24 all  Others (3%), participated in the clinical trial.
Adapted from FDA Clinical review
Table 2. Baseline Demographics by Race
RaceNumber of PatientsPercentage
White68994
Black or African American142
American Indian or Alaska Native51
Unknown2less than 1%
Other223
Adapted from FDA Clinical review
Figure 5 summarizes the percentage of patients by age in Clinical Trials 1 and 2 combined.
Figure 5. Baseline Demographics by Age (Trials 1 and 2 combined)
Pie charts summarizing how many individuals of certain age groups were in the clinical trials 1 and 2. In total, 980 patients  were younger than 40 years (59%), and  676 patients were  40 years and older (41 %).
Adapted from FDA Clinical review
Figure 6 summarizes the percentage of patients by age in Clinical Trial 3.
Figure 6. Baseline Demographics by Age (Trial 3)
Pie charts summarizing how many individuals of certain age groups were in the clinical trial 3. In total, 188 patients  were younger than 40 years (26%), and  544 patients were  40 years and older (74 %).
Adapted from FDA Clinical review

How were the trials designed?

The benefits and side effects of OCREVUS for RMS were established in two clinical trials of patients with MS who had experienced at least one relapse within the prior year, or two relapses within the prior two years.
Patients received treatment with either OCREVUS or another MS drug, Rebif, for 96 weeks. Neither the patients nor the health care providers knew which treatment was being given until the trial was completed.
The benefit of OCREVUS was evaluated by comparing the yearly relapse rate between the groups.
The benefits and side effects of OCREVUS for PPMS were evaluated in one clinical trial of patients with a certain pre-determined degree of disability measured by Expanded Disability Status Scale (EDSS). Patients received treatment with either OCREVUS or placebo for at least 120 weeks. Neither the patients nor the health care providers knew which treatment was being given until the trial was completed.
The benefit of OCREVUS was evaluated by comparing the time to disability progression in each group through neurological examination. Disability progression occurred when the baseline degree of disability (EDSS score) increased by 1 point or more from the baseline EDSS if the baseline EDSS was 5.5 points or less or by 0.5 points or more if the baseline EDSS was more than 5.5 points. To count as progression the observed disability had to last for 12 weeks.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

No hay comentarios:

Publicar un comentario