A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial

Abstract

ObjectivesTo compare efficacy and safety of ixekizumab (IXE) to adalimumab (ADA) in biological disease-modifying antirheumatic drug-naïve patients with both active psoriatic arthritis (PsA) and skin disease and inadequate response to conventional synthetic disease-modifying antirheumatic drug (csDMARDs).MethodsPatients with active PsA were randomised (1:1) to approved dosing of IXE or ADA in an open-label, head-to-head, blinded assessor clinical trial. The primary objective was to evaluate whether IXE was superior to ADA at week 24 for simultaneous achievement of a ≥50% improvement from baseline in the American College of Rheumatology criteria (ACR50) and a 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI100). Major secondary objectives, also at week 24, were to evaluate whether IXE was: (1) non-inferior to ADA for achievement of ACR50 and (2) superior to ADA for PASI100 response. Additional PsA, skin, treat-to-target and quality-of-life outcome measures were assessed at week 24.ResultsThe primary efficacy endpoint was met (IXE: 36%, ADA: 28%; p=0.036). IXE was non-inferior for ACR50 response (IXE: 51%, ADA: 47%; treatment difference: 3.9%) and superior for PASI100 response (IXE: 60%, ADA: 47%; p=0.001). IXE had greater response versus ADA in additional PsA, skin, nail, treat-to-target and quality-of-life outcomes. Serious adverse events were reported in 8.5% (ADA) and 3.5% (IXE) of patients.ConclusionsIXE was superior to ADA in achievement of simultaneous improvement of joint and skin disease (ACR50 and PASI100) in patients with PsA and inadequate response to csDMARDs. Safety and tolerability for both biologicals were aligned with established safety profiles.

Association between clinical specialty setting and disease management in patients with psoriatic arthritis: results from LOOP, a cross‐sectional, multi‐country, observational study

“…3,12 Another difference between the specialties was that treatment with non-TNF inhibitor bDMARDs (such as IL-12/-23 and IL-17 inhibitors) was more common in the dermatology setting, whereas treatment with TNF inhibitors was more common in the rheumatology setting. This may be because IL-12/-23 and IL-17 inhibitors have greater efficacy in the treatment of psoriasis, [13][14][15][16] compared with TNF inhibitors. Closer collaboration between the specialties may allow selection of a treatment regimen targeted to the individual patient's disease, including both joint and skin manifestations.…”

Peripheral spondyloarthritis: a neglected entity—state of the art

“…A similar observation with regard to enthesitis index was also observed in the SPIRIT-H2H study that compared IL17 inhibition with ixekizumab to adalimumab: a significantly higher proportion of patients reached a SPARCC enthesitis score equal to zero at week 24 in the ixekizumab group. 57…”

Interleukin-17A and Keratinocytes in Psoriasis

“…As the clinical response to anti-IL-23/IL-17A biologics seems better than that to anti-TNF-α biologics in psoriasis, the IL-23/IL-17A axis likely plays a more crucial role than the TNF-α axis in the development of psoriasis [67][68][69][70][71]. Under the regulation of IL-23p19, IL-17A-producing CD4 + helper T (Th17) cells create a self-amplifying, feed-forward inflammatory response that is markedly augmented in the presence of TNF-α [68,72,73].…”