Renflexis (Infliximab) for Severe Refractory Rheumatoid Arthritis

Clinical Justification for Approval

The American College of Rheumatology guidelines acknowledge that biologics can be used without methotrexate when methotrexate is contraindicated or not tolerated, as in the case of this patient with documented methotrexate-induced hepatotoxicity 4, 5
The European League Against Rheumatism (EULAR) guidelines support biologic DMARD use in patients intolerant to methotrexate, with alternative conventional DMARDs as acceptable combination partners 1
This patient has severe structural damage, including thumb 'Z' deformities and bilateral wrist fusion, indicating aggressive disease requiring effective control to prevent further irreversible damage 4
The patient has failed or not tolerated four different biologic DMARDs, and prior response to infliximab establishes medical necessity for this therapy 2, 3, 4, 1

Interrupting effective therapy (infliximab) poses high risk of disease flare, accelerated structural damage, and worsening disability in a patient with already severe joint destruction 4, 5
The patient is currently experiencing increased joint pain and swelling on rituximab, indicating active disease requiring more effective control 5

Clinical guidelines explicitly state that methotrexate-intolerant patients may use TNF inhibitors as monotherapy or with alternative DMARDs, supporting the use of infliximab in this patient 1, 4
Patient-reported outcomes are valid measures of treatment response, particularly when combined with clinical context of multiple biologic failures, and this patient reports meaningful improvement on infliximab 4, 5

The American College of Rheumatology recommends monitoring disease activity every 1-3 months using validated measures to assess response, and considering dose escalation of infliximab or addition of alternative DMARD if inadequate response by 3 months 5
Screening for tuberculosis and hepatitis B prior to initiation of infliximab is recommended, as with all TNF inhibitor therapy 4