Relapsing Multiple Sclerosis (RMS)

Also known as: Relapsed Multiple sclerosis / Multiple Sclerosis Relapse / Relapsing Multiple Sclerosis / Multiple sclerosis flare

DrugDrug NameDrug Description
DB00111DaclizumabHumanized IgG1 Mab that binds to the human interleukin-2 receptor (anti-Tac or anti-CD25). Daclizumab is a composite of human (90%) and murine (10%) antibody sequences. The human sequences were derived from the constant domains of human IgG1 and the variable framework regions of the Eu myeloma antibody. The murine sequences were derived from the complementarity-determining regions of a murine anti-Tac antibody. On 22 April 2008, Roche Registration Limited chose to voluntarily withdraw the marketing authorization for their product Zenapax (daclizumab), as indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation and used concomitantly with an immunosuppressive regimen like cyclosporine and corticosteroids in patients who are not hight immunized, for commercial reasons and confirmed that this decision was not related to any safety concerns associated with the use of Zenapax (daclizumab) [L1744]. Regardless of the withdrawal of Zenapax, Biogen and Abbvie's Zinbryta (daclizumab), as indicated for the treatment of adult patients with relapsing forms of multiple sclerosis, was approved for use by the FDA in 2016 [L1746]. Despite being approved for use, Zinbryta (daclizumab)'s complex pre-existing safety profile consisting of its restricted availability through a Risk Evaluation and Mitigation Strategy program [L1738] and its black box warning for possible hepatic injury, autoimmune hepatitis, and other immune mediated disorders [L1738] meant its therapeutic usage, adverse effects, and prescribing information was subject to continuous monitoring and updating. Although Zinbryta (daclizumab) was available for patients as needed until 30 April 2018, Biogen and Abbvie announced a voluntary withdrawal of their product Zinbryta (daclizumab) from the global market on 2 March 2018 [L1738]. This withdrawal was concurrent to the European Medicines Agency announcement of a recall owing to 12 worldwide reports of serious inflammatory brain disorders associated with the use of Zinbryta (daclizumab) [L1738].
DB11988OcrelizumabOcrelizumab is a CD20-directed cytolytic antibody indicated for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis. It is a second-generation recombinant humanized monoclonal IgG1 antibody that selectively targets the B lymphocytes that express the CD20 antigen. As a humanized molecule, ocrelizumab is expected to be less immunogenic with repeated infusions which improves the benefit-to-risk profile for patients with relapsing or progressive forms of MS. Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease of the central nervous system that leads to neurological disabilities and significantly reduced quality of life [L1199]. Most patients with MS experience episodes of relapses with worsening function, followed by recovery periods, or remissions. Primary progressive multiple sclerosis (PPMS) accounts for 10-15% of the overall population of patients with MS, and involves gradual worsening of neurologic disability from symptom onset, often without early relapses or remissions [A31741]. Developed by Genentech/Roche, ocrelizumab was approved by the FDA in March 2017 under the market name Ocrevustm for intravenous injection. It was later approved by Health Canada (as Ocrevus) in August 2017, making the drug the first available treatment for PPMS in both U.S. and Canada. In clinical trials of patients with relapsing forms of MS, treatment with ocrelizumab resulted in reduced relapse rates and reduced worsening of disability compared to interferon beta-1a [L1199]. In phase 3 clinical trials of patients with PPMS, treatment with ocrelizumab demonstrated lower rates of clinical and MRI progression than placebo [A31741].
DrugDrug NamePhaseStatusCount
DB05092CDP3231 / 2Completed1
DB00060Interferon beta-1a2 / 3Completed1
DB12612Ozanimod2 / 3Completed2
DB00060Interferon beta-1a3Active Not Recruiting2
DB00068Interferon beta-1b3Terminated1
DB11988Ocrelizumab3Active Not Recruiting2
DB09122Peginterferon beta-1a3Completed3
DB12016Ponesimod3Active Not Recruiting1
DB08880Teriflunomide3Active Not Recruiting1
DB00060Interferon beta-1a4Completed1
DB09122Peginterferon beta-1a4Withdrawn1
DB00060Interferon beta-1aNot AvailableCompleted1
DB00060Interferon beta-1aNot AvailableRecruiting1
DB00108NatalizumabNot AvailableCompleted1
DB09153Sodium ChlorideNot AvailableCompleted1