The Rheumatoid Arthritis Scenario in India

Introduction

Rheumatoid Arthritis (RA) is a systemic disease—an autoimmune disorder in which the body's defense system attacks the joints through the thin layer of cells called the synovium that lines and lubricates the joints. The most visible symptoms of RA are swollen joints and crippling stiffness, particularly of the hands and feet. It can cause fatigue, fever, loss of appetite, and also impedes mobility and quality of life.

RA is a common autoimmune disease, which affects about 20 million persons worldwide. The disease commonly develops between the ages of 25 and 50 and given its progressive nature, patients often live for 30 years or more with the disease.

Incidence and Prevalence

In India there are about 11 million people with RA, of whom about 75.0 percent are women. While India would require about 70,000 specialists to treat them all, it has only between 100 and 150 rheumatologists at present, putting pressure on them in terms of patient load and the time they are able to spend with each patient.

Prevalence of RA was about 0.75 percent in 2004, and has risen to 1.0 percent in 2007. The number of diagnosed patients is likely to increase due to the increasing awareness of the disease. As for treatment, DMARDs are the treatment of choice and for moderate to severe cases, biologics may be added. Unlike other countries, Remicade was the first biologic to be available in the market, although Enbrel captured a larger market share after it was introduced.

Diagnostic Tests

The diagnosis of RA is based on clinical examination of symptoms, patient history, as well as blood tests. There is no absolute test that can confirm or exclude RA. Some of the common tests include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), and X-ray.

Rheumatologists use a suite of parameters in confirming an RA diagnosis and monitoring disease progression.

The vital parameters in confirming diagnosis and determining disease progression are:

• Number of swollen joints

• Presence of morning stiffness

• Number of tender joints

• Functional status

Key Treaters and Patient Flow

GPs treat patients for joint-ache with steroids and NSAIDs, and refer RA patients to orthopedic surgeons and rheumatologists for further treatment. Orthopedic surgeons, also, are often the first point of contact. They would diagnose and prescribe DMARDs. Patients with severe RA or those who require treatment beyond DMARDs are directed to a rheumatologist. Rheumatologists are the key treaters of RA.

The main treatment goals include:

• Reduction in pain, swelling and thus the inflammation

• Reducing joint deformity

• Improving quality of life

Treatment Options

Most of the patients are initially treated with only drugs. Patients on drugs and physiotherapy would be those with concomitant diseases. Patients also practice yoga, exercises that are designed to cure the inflicted joints by slow movements and gentle pressure in conjunction with deep breathing. There are a very small proportion of patients who are not on any treatment because of their refusal to be treated.

Most commonly used drugs for the treatment and management of Rheumatoid arthritis are:

• Steroids / NSAIDs (Non Steroidal Anti Inflammatory Drugs) / Cox-2 inhibitors
• DMARDS (Disease Modifying Anti-Rheumatic Drugs) in monotherapy or combination therapy
• Biologics

Though Biologics are the most effective treatment options available till date for the RA treatment, high cost of therapy acts as a barrier for its frequent usage. Available biologics in India are Enbrel (Etanercept), Remicade (Infliximab), Orencia (Abatacept), Rituxan/Mabthera (Rituximab) and Actemra (Tocilizumab).

Treatment Filter

-- Total RA patients: 100%

-- Patients diagnosed: 3.37%

-- RA patients available for treatment: 2.5%

-- RA patients eligible to be treated with biologics: Less than 1%

-- Patients actually treated with biologics: !!!

Government and Non-government Initiatives

Mission Arthritis India (MAI) is a voluntary support group for patients of arthritis and rheumatism, established in 2000. It was formed by a group of people who are suffering from chronic arthritis and wish to help the community fight these ailments. The main goal of MAI is to provide proper and scientific information and guidance about all aspects of arthritis and related problems. MAI publishes quarterly newsletters containing health-related articles and organizes public awareness meetings during the week 12 - 20 October every year, in which the annual health magazine is inaugurated. Various health talks by well-known doctors from the field of orthopedics, rheumatology and other specialties are also arranged in this program.

Bone and Joint Decade India : National Action Networks (BJD – India: NAN), under the umbrella of the WHO-endorsed Bone and Joint Decade 2000 – 2010, is engaged in disseminating general awareness about rheumatic musculoskeletal disorders both for the medical community and the Indian public. It has established corporate partnerships with some Indian pharmaceutical companies that are interested in building awareness. The organization has also set up multiple studies to collect population-based prevalence data.

Market Challenges

• High cost of treatment with biologics
• Lack of awareness among the patients
• Low Rheumatologists to patient ratio
• Low reimbursement scenario
• Patients drop out because of low compliance results
• Around 30% of patients are non-compliant with treatment with DMARDs either due to side effects, Patients’ attitude that the treatment is not working or inclination to use alternative therapies.

• More than 90% of patients do not continue treatment with biologics till one year either due to high cost of biologics or side effects. In many cases where patient pay out of pocket for biologics, it is given to relieve the patient from painful symptoms and then treatment is continued with DMARDs.

Future Outlook

Though there are biologics available for treating RA, specialists in India will continue to use DMARDs as their first line therapy, because of high cost of treatment and fear of side effects associated with long term usage with biologics. However, improving reimbursement scenario, increasing disposal income, increasing awareness among the Indian population about RA and continuous effort by the companies for increasing usage of biologics are few of the factors which will drive the growth of RA market.

Author Information:
- Bibhuti Bhusan Kar, Program Manager - Pharmaceuticals and Biotechnology, Frost & Sullivan, India.

- Source: Pharma Bio World, April 2010

-Link: http://www.pharmabioworld.com/archives.html