NICE Publish Guidance on Adalimumab, etanercept, infliximab, rituximab and adataqcept for the treatment of rheumatoid arthritis after failure of a TNF Inhibitor.

Full Text Here

Rituximab in combination with methotrexate is recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to, or are intolerant of, other disease-modifying anti-rheumatic drugs (DMARDs), including at least one tumour necrosis factor (TNF) inhibitor. Treatment with rituximab should be given no more frequently than every 6 months.

Treatment with rituximab in combination with methotrexate should be continued only if there is an adequate response following initiation of therapy and if an adequate response is maintained following retreatment with a dosing interval of at least 6 months. An adequate response is defined as an improvement in disease activity score (DAS28) of 1.2 points or more.

Adalimumab, etanercept, infliximab and abatacept, each in combination with methotrexate, are recommended as treatment options only for adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab therapy because they have a contraindication to rituximab, or when rituximab is withdrawn because of an adverse event.

Adalimumab monotherapy and etanercept monotherapy are recommended as treatment options for adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab therapy because they have a contraindication to methotrexate, or when methotrexate is withdrawn because of an adverse event.

Treatment with adalimumab, etanercept, infliximab and abatacept should be continued only if there is an adequate response (as defined in 1.2) 6 months after initiation of therapy. Treatment should be monitored, with assessment of DAS28, at least every 6 months and continued only if an adequate response is maintained.

When using DAS28, healthcare professionals should take into account any physical, sensory or learning disabilities, communication difficulties, or disease characteristics that could adversely affect patient assessment and make any adjustments they consider appropriate.

A team experienced in the diagnosis and treatment of rheumatoid arthritis and working under the supervision of a rheumatologist should initiate, supervise and assess response to treatment with rituximab, adalimumab, etanercept, infliximab or abatacept.

For a Market Access and Health Economics Expert Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”