Ixekizumab found to be safe and effective in the Management of Active Psoriatic Arthritis

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Ixekizumab found to be safe and effective in the Management of Active Psoriatic Arthritis

Psoriatic arthritis (PsA) can be managed by Ixekizumab (IXE), an IgG4 monoclonal antibody with property to selectively target pro-inflammatory cytokine IL-17A, due to its high binding affinity. Phase III of a study (SPIRIT P1) analyzed the efficacy and safety of IXE in patients with active PsA over 52 weeks. It was found that IXE targets explicitly interleukin-17A (IL-17A), in patients with active PsA and with inadequate response to tumor necrosis factor inhibitors (TNFi) before.

To assess the efficacy and safety of IXE in 417 patients with active PsA over 52 weeks, where in a Double-Blind Treatment Period (DBPT) [0 TO 24 weeks], bDMARD-naive patients with active PsA were randomized into 1:1:1:1, providing IXE dose- 80 mg [once in 4 weeks (Q4W)], IXE - 80mg (once every 2 weeks) and 40 mg adalimumab (ADA) [once in 2 weeks (Q2W)], or PBO placebo (all subcutaneous dosing). Both IXE regimens included a 160-mg starting dose.

From these, 381 patients completed the DBTP and went for Extension Period (EP: Weeks 24 to 52) and were provided IXE - 80 mg [Q4W or Q2W]. Patients randomized to IXE at Week 0 carried on with same dose regimen in the EP. Patients randomized to PBO or ADA at Week 0 were again randomized (1:1) to IXE - 80 mg [Q4W or Q2W] at Week 16 (inadequate responders) or 24. Patients who initially received PBO started IXE at 16th or 24th week; patients who initially received ADA started IXE at 24th or the 32nd week after a washout period of 8 weeks.

Efficacy and safety analysis was done using the Extension period (EP) population which includes all patients who at least received a single dose of study drug in EP. Missing values were attributed to non-responder imputation for categorical data, and modified baseline observation carried forward for continuous data.

Efficacy evaluation was counted with ACR20/50/70 response, HAQ-Disability Index (HAQ-DI) Score, Disease Activity Score 28 diarthrodial joint count based on C-reactive protein (DAS 28-CRP), Psoriasis Area and Severity Index 75, 90, 100 (PASI 75/90/100), Leeds Enthesitis Index (LEI), and Leeds Dactylitis Index-Basic (LDI-B).

304 patients completed the EP, and it was concluded that there were improvements from baseline in ACR20/50/70, HAQ-DI, DAS 28-CRP, PASI 75/90/100, LEI and LDI-B at Week 52. The treatment emerging adverse events (AEs) in the EP were similar to that found in the DBTP; the majority were mild or moderate in severity. The appearance of Serious AEs in 12 patients and no deaths resulted in the EP population.

Results showed that IXE exhibited clinically remarkable improvement in signs and symptoms of PsA such as arthritis, dactylitis, and enthesitis as well as skin manifestations across treatment groups in the EP. It was observed that safety of IXE was similar to that was of the DBTP and another phase III studies of IXE in patients with plaque psoriasis in some other studies.


American College of Rheumatology

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The original title of article:

Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52 Week Results from a Phase 3 Study


Philip J Mease, Masato Okada et al. 

Therapeutic, Psoriatic Arthritis, Ixekizumab, Skin, Joints, Monoclonal Antibody, Phase 2 study, Efficacy, Safety, ACR20/50/70, HAQ-DI, DAS 28-CRP, PASI 75/90/100, LEI, LDI-B
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