1 Recommendations

1.1 Risankizumab, alone or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have:

  • peripheral arthritis with 3 or more tender joints and 3 or more swollen joints

  • moderate to severe psoriasis (a body surface area of at least 3% affected by plaque psoriasis and a Psoriasis Area and Severity Index [PASI] score greater than 10)

  • had 2 conventional DMARDs and at least 1 biological DMARD.

    Risankizumab is recommended only if the company provides it according to the commercial arrangement.

1.2 Assess the response to risankizumab from 16 weeks. Stop risankizumab if psoriatic arthritis has not responded adequately using the Psoriatic Arthritis Response Criteria (PsARC; an adequate response is an improvement in at least 2 of the 4 criteria, 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria). If PsARC response does not support continuing treatment but there is a PASI 75 response, a dermatologist should decide whether continuing treatment is appropriate based on skin response.

1.3 If risankizumab is one of a range of suitable treatments, including guselkumab, choose the least expensive (taking into account administration costs, dosage, price per dose and commercial arrangements).

1.4 Take into account any physical, sensory or learning disabilities, or communication difficulties that could affect the responses to the PsARC, and make any adjustments needed.

1.5 Take into account how skin colour could affect the PASI score and make any adjustments needed.

1.6 These recommendations are not intended to affect treatment with risankizumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

People with psoriatic arthritis that is not controlled well enough with 2 conventional DMARDs are usually offered biological DMARDs. People whose disease has not responded to a biological DMARD and who also have moderate to severe psoriasis may be offered guselkumab, an IL‑23 modulator already recommended by NICE. Risankizumab is also an IL‑23 modulator.

Clinical evidence shows that risankizumab is effective for active psoriatic arthritis compared with placebo. Risankizumab has not been compared directly with other biological DMARDs for psoriatic arthritis. But the results of an indirect comparison suggest that it is as effective as guselkumab, particularly for skin and joint symptoms, and likely has similar safety.

Risankizumab has similar costs to guselkumab for people with moderate to severe psoriasis who have had 2 conventional DMARDs and at least 1 biological DMARD. So, risankizumab is recommended as an option for treating active psoriatic arthritis in this group.

  • National Institute for Health and Care Excellence (NICE)