UCB has reported that Cimzia (certolizumab pegol), together with methotrexate (MTX), has showed sustained improvements in ACR20, physical function, pain and fatigue of rheumatoid arthritis (RA) as early as the first week. The company has said that it had inhibited progression of structural joint damage at week 24. Further, this improvement was shown to be sustainable upto 100 weeks. Reportedly, Cimzia was approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis. The drug can be dosed at 400 mg initially and at weeks 2 and 4, followed by 200 mg every other week. Maintenance dosing can be at 400 mg every 4 weeks.
The company also presented data from a post hoc analysis at the Annual Scientific Meeting of the American College of Rheumatology (ACR) in Philadelphia. This data showed that the speed of developing a clinical response to treatment with 200 mg Cimzia and MTX was important in improving long-term outcomes for patients living with active RA. The analysis found most patients achieved early control at week 6. These patients had significantly better control of symptoms and significantly better improvements in pain and physical function at one year, compared to patients who achieved a later response at week 12.
The post hoc analysis presented at the meeting investigated the relationship between the kinetics of response and long-term outcomes in patients who responded to treatment with 200 mg Cimzia every 2 weeks and MTX, as measured by ACR20 response or change in DAS28 of greater than or equal to 1.2 from baseline.
Early week 6 responders had significantly higher ACR20, ACR50 and ACR70 responses at week 52, compared to the later week 12 responders [ACR20 83.1% versus 66.7%; ACR50 66.7% versus 34.5%; and ACR70 39.0% versus 16.1%, respectively. Patients with an early ACR20 response at Week 6 also experienced significantly greater improvements in physical function (HAQ-DI) and pain relief (VAS), compared to later Week 12 responders, and early Week 6 Disease Activity Score (DAS28) responders reported significantly greater pain relief.
Radiographic data presented from the RAPID 1 open-label extension study found the inhibition of progression of structural joint damage observed from baseline to week 24 and week 52 was maintained out to week 100 in patients who completed treatment with Cimzia and MTX. The mean change from baseline in modified total Sharp score for the combined Cimzia dose groups at week 100 was 0.59.
In the same study, rapid improvements in ACR(a) scores were sustained up to 100 weeks in patients maintained on open-label treatment with 400 mg Cimzia every 2 weeks and MTX in the RAPID 1. ACR20 response rates at week 100, in patients who completed treatment with Cimzia were 68.2% and 69.5% for patients who originally received Cimzia 200 mg or 400 mg every 2 weeks plus MTX, respectively. ACR50 response rates were 55.2% and 51.5% respectively. Similar results were also observed for DAS28, and patient reported outcomes such as physical function and health-related quality of life.
Edward Keystone, lead investigator at The Rebecca MacDonald Center for Arthritis, Mount Sinai Hospital, The University of Toronto, said: “These recently published data have shown Cimzia to work rapidly, and demonstrate that an early response to treatment is associated with greater improvements in long-term outcomes. The data also confirm the rapid and sustained effect of Cimzia in providing effective and clinically meaningful relief of rheumatoid arthritis, and reducing disease progression. This highlights the importance of getting the disease under control quickly in this debilitating condition which helps improve overall quality of life.”