|Year : 2018 | Volume
| Issue : 1 | Page : 4-5
Greater access to safe and effective therapeutic options in rheumatoid arthritis
Rajkiran Dudam1, Vinod Ravindran2
1 Hyderabad Rheumatology Centre, Hyderabad, Telangana, India
2 Centre for Rheumatology, Calicut, Kerala, India
|Date of Web Publication||26-Feb-2018|
Dr. Vinod Ravindran
Centre for Rheumatology, Calicut - 673 009 Kerala
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Dudam R, Ravindran V. Greater access to safe and effective therapeutic options in rheumatoid arthritis. Indian J Rheumatol 2018;13:4-5
Cost is the key, and hence, both in developed and developing nations, economics drive the therapeutics. Every option is explored by caregivers and takers for affordable best care. The entry of biosimilars in rheumatology has made it more affordable for many, but how best are they in terms of safety and efficacy remains under discussion.
In the last decade, the world has been flooded with biosimilars. Various terms such as intended copies, biocopies, biomimics, and biobetters are used to describe them based on the technical nuances and on kind of testing they undergo and the regulatory bodies' approvals. To provide best care to patients, physicians are rightly compelled to consider the data available. In this context, a study by Hegde et al. in the present issue of the Journal appraises the safety and efficacy of a rituximab biosimilar.
The present study measured serum immunoglobulin status in patients receiving rituximab; the IgG and IgM declined by 24% and 37%, respectively, at the end of 24 weeks but did not cause any serious adverse effects. Equally important was the absence of tuberculosis or hepatitis B reactivation. The data also found favorable comparison with landmark DANCER, REFLEX, and SERENA studies.,, In this study and in the study by Ravindran et al., infusion reactions were 16% and 10% during the first infusion, respectively, with no instances during subsequent infusions., These reactions are less compared to DANCER group; however, the studies were limited in numbers.
In this study the mean DAS28ESR had a statistically significant increase at week 24 to 4.01; this rise in titers was statistically significant when compared to scores at 12th week (P< 0.04); however, it is less than baseline DAS28ESR of 5.92. This suggests that a patient subgroup might have needed a second infusion of rituximab. Follow-up data at 52 weeks of such patients and if a second course of B-cell depletion was given under those circumstances need to be published as well. The mean duration for csDMARDs before initiating B-cell depletion in this study was 8.4 years. We hope that in future with increasing data on efficacy and safety combined with reduced costs of biosimilars, the mean duration to start biological agent in csDMARDs failures can be reduced.
As the affordability forces us to move toward biosimilars, the present study combined with earlier data on the same molecule helps clear the reservations about choosing this rituximab biosimilar.,, However, there are some important further requirements:
- At present in India apart from the originator rituximab at least 3 biosimilar versions are available. Limited data about other rituximab biosimilars exist, and researchers should consider sharing their experience regarding other rituximab biosimilars too as no two biosimilars can really be similar
- There is a wide range of biosimilar products being used in India, and pooling of real-life usage data from multiple centers such as done recently by the Karnataka rheumatology group is going to be helpful
- Apart from RA, the usage for biosimilar B-cell depletion had significantly expanded in the recent past, and in India, many rheumatologists now use it for ANCA-associated vasculitis, refractory lupus, scleroderma, and myositis. Such data also need to be captured. One good example is the recent 4th Indo-UK 2018 Rheumatology Summit held at Calicut wherein rheumatologists had presented several case reports of rituximab biosimilar usage in myositis.
As low-cost biosimilars with good safety and efficacy data becoming available, potential of steroid-free regime in not only rheumatoid arthritis but other autoimmune diseases appears a real possibility. Like the present study, the need of the hour is published and publicized experience of their real-life usage.
| References|| |
Hegde A, Vasdev V, Shanmuganandan K, Singh K, Kartik S, Kumar A. Safety and efficacy of an anti-CD20 monoclonal antibody (Reditux™) in Indian patients with seropositive rheumatoid arthritis. Indian J Rheumatol 2018;13:20-5. [Doi: 10.4103/injr.injr_98_17].
Roshique KK, Ravindran V. Efficacy and safety of a biosimilar rituximab in biologic naïve patients with active rheumatoid arthritis. Clin Rheumatol 2015;34:1289-92.
Emery P, Fleischmann R, Filipowicz-Sosnowska A, Schechtman J, Szczepanski L, Kavanaugh A, et al.
The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: Results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum 2006;54:1390-400.
Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, et al.
Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum 2006;54:2793-806.
Emery P, Deodhar A, Rigby WF, Isaacs JD, Combe B, Racewicz AJ, et al.
Efficacy and safety of different doses and retreatment of rituximab: A randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis 2010;69:1629-35.
Narayanan K, Bhakuni DS, Garg OP. Experience with rituximab in rheumatoid arthritis. Indian J Rheumatol 2009;4:136-7. [Full text]
Santhanam S, Rajeshwari S, Tamilsevam T, Madeshwaram M. Rituximab in biologically naıve rheumatoid arthritis patients and methotrexate non-responders – An Indian experience. Indian J Rheumatol 2015;10:177-8. [Full text]
Bhati M, Bandyopadhyay S. Efficacy and safety of an anti-CD20 monoclonal antibody (Reditux™) for the treatment of patients with moderate to severe rheumatoid arthritis following the failure of conventional synthetic disease-modifying anti-rheumatic drugs. Clin Rheumatol 2016;35:1931-5.
Mohan B, Ravindran V. No impact of sero-negativity on the efficacy of biosimilar rituximab in biologic naïve patients with active rheumatoid arthritis. Indian J Rheumatol 2016;11 Suppl 1:35.
Chandrashekara S, Shobha V, Dharmanand BG, Jois R, Kumar S, Mahendranath KM, et al.
Reduced incidence of extra-articular manifestations of RA through effective disease control: Karnataka Rheumatoid Arthritis Comorbidity (KRAC) study. Int J Rheum Dis 2017;20:1694-703.