1.1 Guselkumab, 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, only if they have:
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.
Guselkumab is recommended only if the company provides it according to the commercial arrangement.
1.2 Assess the response to guselkumab from 16 weeks. Stop guselkumab at 24 weeks 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 justify continuing treatment but there is a PASI 75 response, a dermatologist should decide whether continuing treatment is appropriate based on skin response.
1.3 Take into account any physical, sensory or learning disabilities, or communication difficulties that could affect the responses to the PsARC, and make any appropriate adjustments.
1.4 Take into account how skin colour could affect the PASI score, and make any appropriate adjustments.
1.5 These recommendations are not intended to affect treatment with guselkumab 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
Guselkumab is a biological DMARD. People with psoriatic arthritis that is not controlled well enough with 2 conventional DMARDs are usually offered biological DMARDs. Many of these are already recommended by NICE for treating psoriatic arthritis.
Clinical evidence shows that guselkumab is effective for active psoriatic arthritis compared with placebo. Guselkumab has not been compared directly with other biological DMARDs for psoriatic arthritis. But the results of an indirect comparison suggest that guselkumab is as effective as the biological DMARDs secukinumab and ixekizumab for the outcomes included in the comparison, and particularly for skin symptoms.
Guselkumab's cost-effectiveness estimates are within what NICE normally considers acceptable for some people with psoriatic arthritis. That is, people who have had 2 conventional DMARDs and at least 1 biological DMARD, and with moderate to severe psoriasis. So guselkumab is recommended for this group.