Background Psoriatic arthritis (PsA) is an immune mediated inflammatory disorder that affects 10–30% of patients with psoriasis. Ustekinumab, a monoclonal anti–IL-12/23p40 antibody, is approved for the treatment of PsA and plaque psoriasis1 PSUMMIT 1 was one of two phase 3 trials of ustekinumab in adults with active PsA2In England, use of medication is subject to guidance from National Institute for Health and Care Excellence (NICE). [TA340] recommend that Ustekinumab is a possible treatment, alone or with methotrexate, for adults with active psoriatic arthritis when treatment with non-biological disease-modifying antirheumatic drugs has not worked well enough if: treatment with tumour necrosis factor (TNF) alpha inhibitors is not suitable for them, or the person has had a TNF alpha inhibitor before3 We audited the survival data from our cohort of patients in district general hospital (DGH) against data from PSUMMIT trial.
Objectives Our objectives were to evaluate drug survival of Ustekinumab in PsA, to compare real world data with that from PSUMMIT trial.
Methods Our biologics database was searched for patients currently receiving Ustekinumab treatment for Psoriatic Arthritis and those who have had treatment failures. Length of treatment was recorded and any adverse effects which caused the treatment to be stopped. Analysis of treatment non-responders was performed including previous biologics/drug use. We then compared our results to those in the treatment arms (Ustekinumab 45mg or 90mg)of the PSUMMIT trial at week 24 and 52.
Conclusions Ustekinumab has been shown to be a generally well tolerated drug. Our treatment group had proportionally more treatment failures than the PSUMMIT trial (4/20 20% vs 24/409 5.8%). There is the obvious criticism that our patient numbers are very small. For eligibility in PSUMMIT trial the patients had to be anti-TNF naïve. In NHS ENgland, Ustekinumab is not NICE approved as a first line agent except in certain circumstances.Therefore, our patients have had previous exposure to anti-TNF agents to which they have either been intolerant or found ineffective. More research into drug survival and persistence should be considered as real world data may not reflect RCT results.
Stelara: package insert. Horsham (PA): Janssen Biotech; 2014.
McInnes IB, Kavanaugh A, Gottlieb AB, Puig L, Rahman P, Ritchlin C, et al. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet 2013;382:780–9.
Ustekinumab for treating active psoriatic arthritis.NICE, Technology appraisal guidance [TA340] Published date: 04 June 2015.
Disclosure of Interest None declared