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Octocrylene daclizumab (OCR) is a recombinant humanized monoclonal antibody, selectively remove the B cells expressing CD20, while retaining the ability of the recombinant B-cell and existing humoral immunity force
.
The results of these trials showed that compared with interferon (IFN) β-1a or placebo, OCR almost completely inhibited new brain MRI activity, significantly reduced the progression of disability, and compared with IFNβ-1a, relapsed activity was significantly reduced
.
The clinical benefits of OCR proved to be sustained during the follow-up period of up to 7 years, and in patients who started OCR treatment earlier, there was a more favorable disability outcome
In the controlled treatment phase (CTPs) of the pivotal Phase 3 trial, infusion-related reactions (IRRs), respiratory infections, and urinary tract infections (UTIs) were the most common adverse events (AEs) associated with OCR
.
Among patients treated with OCR, an imbalance in the number of malignant tumors was observed relative to the reference, which was mainly driven by a higher breast cancer rate; in general, these events were uncommon
.
Therefore, in order to understand the long-term benefit-risk status of OCR in patients with MS (PwMS), safety monitoring is needed
Breast Cancer Therefore, in order to understand the long-term benefit-risk status of OCR in patients with MS (PwMS), safety monitoring is required
The safety analysis is based on the comprehensive clinical and laboratory data of all patients undergoing OCR in 11 clinical trials, including the controlled treatment and open label expansion (OLE) phases of phase 2 and phase 3 trials, and phase 3b trials of VELOCE, CHORDS, and CASTING , OBOE, ENSEMBLE, CONSONANCE and LIBERTO
.
For selected adverse events (AEs), additional post-marketing data were used
At the time of the data cutoff (January 2020), 5,680 multiple sclerosis (MS) patients had received OCR in clinical trials (18,218 patient-years [PY] exposure)
.
The incidence of AEs (248; 246-251), severe AEs (7.
3; 7.
0-7.
7), infusion-related reactions (25.
9; 25.
1-26.
6) and infection (76.
2; 74.
9-77.
4) per 100 PY (95% CI ) Similar to the controlled treatment period of the Phase 3 trial
.
3; 7.
0-7.
7), infusion-related reactions (25.
9; 25.
1-26.
6) and infection (76.
2; 74.
9-77.
4) per 100 PY (95% CI ) Similar to the controlled treatment period of the Phase 3 trial
.
The most common rates of severe AEs, including SIs (2.
01; 1.
81-2.
23) and malignant tumors (0.
46; 0.
37-0.
57), are consistent with the range reported in epidemiological data
.
The important significance of this research lies in the discovery: continuous use of OCR in clinical trials for up to 7 years, as well as more extensive use of OCR in the real world for more than 3 years, are all related to good and manageable safety conditions.
There are no safety issues in the MS population
Original source:
Hauser SL, Kappos L, Montalban X, et al.
Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis.
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