Tofacitinib approved by NICE for severe rheumatoid arthritis

NICE guidance states that tofacitinib, in combination with methotrexate, is recommended as an option for treating severe active RA in adults who have responded inadequately to intensive therapy with conventional DMARDs, or who have responded inadequately to (or cannot tolerate) biological DMARDs and cannot have rituximab. 

Tofacitinib can also be used as monotherapy in these patients if methotrexate is contraindicated or not tolerated. 

Severe active RA is defined by a disease activity score > 5.1.

Approval of tofacitinib by NICE is conditional on the company providing the drug with the discount agreed in the patient access scheme.

'Novel treatment'

'Tofacitinib is a novel treatment with a different mode of action to the biological DMARDs,' said the clinical experts of the NICE appraisal committee.

Together with baricitinib (Olumiant), tofacitinib represents a new class of RA treatments known as JAK inhibitors. These drugs prevent JAK enzymes from activating STAT proteins, thus interrupting the signalling channel and halting the message that ultimately produces the inflammatory response seen in RA.

The experts felt that the adverse effects associated with the JAK inhibitors were unlikely to influence their decision to prescribe tofacitinib. They also noted that the drug is given orally, which has major benefits for patients and the healthcare system.

The committee decided, however, that tofacitinib is not cost-effective for the treatment of moderate RA after use of conventional DMARDs.

The most common serious adverse reactions to tofacitinib are serious infections, including pneumonia, cellulitis and herpes zoster. Patients should be closely monitored for infections during and after treatment.