1 Recommendations

Guidance

1.1 Certolizumab pegol, in combination with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to, or who cannot tolerate, other disease-modifying antirheumatic drugs (DMARDs) including at least 1 tumour necrosis factor‑alpha (TNF‑alpha) inhibitor, only if:

disease activity is severe and
rituximab is contraindicated or not tolerated and
the company provides certolizumab pegol with the agreed patient access scheme.

1.2 Certolizumab pegol, as monotherapy, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to, or who cannot tolerate, other DMARDs including at least 1 TNF‑alpha inhibitor, only if:

disease activity is severe and
rituximab therapy cannot be given because methotrexate is contraindicated or not tolerated and
the company provides certolizumab pegol with the agreed patient access scheme.

1.3 Continue treatment only if there is at least a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months. After an initial response within 6 months, withdraw treatment if at least a moderate EULAR response is not maintained.

1.4 This guidance is not intended to affect the position of patients whose treatment with certolizumab pegol was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.