Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1)

Abstract

Objective.To evaluate the efficacy and safety of ixekizumab (IXE), an interleukin 17A antagonist, in patients with psoriatic arthritis (PsA) after 52 weeks in a phase III study.Methods.Patients were initially randomly assigned to IXE 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) after a 160-mg starting dose, placebo (PBO), or adalimumab (ADA) 40 mg Q2W. At Week 24 (Week 16 for inadequate responders), ADA (8-week washout before starting IXE) and PBO patients were rerandomized to IXEQ2W or IXEQ4W. Six treatment groups were evaluated in the extension period (weeks 24–52): IXEQ2W/IXEQ2W, IXEQ4W/IXEQ4W, ADA/IXEQ2W, ADA/IXEQ4W, PBO/IXEQ2W, and PBO/IXEQ4W. The extension period population (EPP) included patients who received ≥ 1 dose of study medication during the extension period.Results.There were 381/417 (91.4%) patients who entered the extension period. In the IXEQ4W/IXEQ4W and IXEQ2W/IXEQ2W groups (EPP), respectively, American College of Rheumatology (ACR)20 (69.1% and 68.8%), ACR50 (54.6% and 53.1%), and ACR70 (39.2% and 39.6%) response rates were sustained at Week 52. Patients rerandomized to IXE also demonstrated efficacy measured by ACR response rates at Week 52. A similar pattern was observed for Psoriasis Area and Severity Index outcomes. Radiographic progression in all 6 groups was minimal. The most frequently reported treatment-emergent adverse events (≥ 4%) were nasopharyngitis, injection site reaction, injection site erythema, upper respiratory tract infection, and back pain. No deaths were reported, and serious adverse event frequency was 0–4% with IXE.Conclusion.During the extension period, IXEQ4W or IXEQ2W treatment demonstrated sustained efficacy in key PsA domains with a safety profile consistent with other studies investigating IXE. Clinical trial number: NCT01695239; EudraCT 2011-002326-49.

Sustainability and switching of biologics for psoriasis and psoriatic arthritis at Fukuoka University Psoriasis Registry

“…A variety of biologics for PsV became available recently, and newer drugs generally have better efficacy without an increase in side-effects. [16][17][18][19][20][21][22][23][24] This led to increased use of the newer drugs with the expectation of better improvement of the skin symptoms. Worldwide, the survival rate of patients taking UST is higher than that of patients taking IFX and ADA.…”

Japanese guidance for use of biologics for psoriasis (the 2019 version)

“…Table 1 shows the list of biologics available for psoriasis in Japan. In the References section, the following are listed as sources for efficacy and safety data in pivotal studies of each biologic in and outside of Japan and for the results of Japanese post-marketing surveillance of each biologic: infliximab, [7][8][9][10][11][12][13][14][15][16] adalimumab, 17-23 ustekinumab, 24-32 secukinumab, [33][34][35][36][37][38][39][40][41][42] ixekizumab, [43][44][45][46][47][48] brodalumab, [49][50][51][52][53][54] guselkumab, 55-61 risankuzumab 62-64 and infliximab BS. 65,66 Additional note: Psoriasis arthropathica and psoriatic arthritis.…”

“…[69][70][71][72][73][74][75][76] • According to the evaluation results of psoriatic arthritis based on the American College of Rheumatology (ACR) response rates, IL-17 inhibitors of secukinumab and ixekizumab are shown to be more effective than ustekinumab and to be as effective as TNF inhibitors. 40,42,46,47 However, in clinical studies in the world, the approved dose and administration, results of placebo, percentages of cases in which bio-switch was performed, and such differed among clinical studies. Therefore, direct comparisons of the effects of these biologics cannot be made.…”

Classification and mitigation of negative injection experiences with biologic medications

“…Various factors contribute to NIEs. The chemical and physical properties of biologics that may contribute to NIEs are summarized in Table 3 (Abbvie, 2018;Eshtiaghi & Gooderham, 2018;European Medicines Agency, 2005Ferris et al, 2019;Immunex Corporation, 2016;Kavanaugh et al, 2012;Lacour et al, 2017;Nakamura et al, 2017;Papp et al, 2016;Sator, 2018;Savage, Wittmann, Mcgonagle, & Helliwell, 2015;US Food and Drug Administration, 2008, 2011, 2017a, 2017c, 2017d, 2018a, 2018b, 2018c, 2019a, 2019bvan der Heijde et al, 2018).…”