Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52

Smolen, Josef S.; Mease, Philip J.; Tahir, Hasan; Schulze‐Koops, Hendrik; Torre, Inmaculada de la; Li, Lingnan; Hojnik, Maja; Sapin, Christophe; Okada, Masato; Caporali, Roberto; Gratacós, Jordi; Goupille, Philippe; Leage, Soyi Liu; Pillai, Sreekumar; Nash, Peter

doi:10.1136/annrheumdis-2020-217372

Cited by 68 publications

(101 citation statements)

References 15 publications

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“…In contrast, ADA efficacy was found to be numerically better with concomitant MTX use than without MTX use. A similar pattern of responses was observed with IXE and ADA when used with all csDMARDs (MTX, leflunomide, sulfasalazine, or cyclosporine) [23]. These results are relevant in clinical practice for informing treatment decisions for patients with PsA for whom MTX may be not recommended (those who have inadequate response or intolerance to MTX) as ADA seems to be less effective than IXE for the treatment of clinical manifestations of PsA in terms of the outcomes in patients who are not taking concomitant MTX.…”

Section: Discussionsupporting

confidence: 66%

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Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study

et al. 2020

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Introduction In the SPIRIT-H2H (ClinicalTrials.gov: NCT03151551) trial in biologic-naïve patients with active psoriatic arthritis (PsA), ixekizumab (IXE) was superior to adalimumab (ADA) at week 24 in terms of achieving a combined endpoint of ≥ 50% improved response in the American College of Rheumatology scale score (ACR50) and 100% improvement in the Psoriasis Areas and Severity Index (PASI100), and was non-inferior in terms of achieving ACR50. IXE resulted in similar improvements of PsA manifestations irrespective of the use of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), while ADA response was higher with concomitant csDMARD use. The aim of this study was to determine the efficacy and safety of treatment with IXE and ADA with or without methotrexate (MTX), the most commonly use csDMARD, through week 52 in patients with PsA. Methods In the open-label, rater-blinded, head-to-head SPIRIT-H2H trial, randomization of patients was stratified by concomitant use of csDMARD and moderate-to-severe plaque psoriasis involvement. In the post-hoc subgroup analysis presented here, subgroups were defined as with/without concomitant MTX use at baseline. Treatment group effects within subgroups were tested using Fisher’s exact test. Missing data were imputed using non-responder imputation. Results By week 52, IXE provided similar improvements in the combined ACR50 and PASI100 endpoint, ACR50, and other PsA-related domains regardless of whether IXE was used with or without MTX, while ADA efficacy appeared to be improved with concomitant MTX use. When used without concomitant MTX, IXE resulted in significantly higher response versus ADA in terms of the combined ACR50 and PASI100 ( p = 0.002) endpoint, minimal disease activity ( p = 0.016), and very low disease activity ( p = 0.037). The safety of both agents was consistent with their known safety profiles regardless of concomitant MTX use. Conclusion In PsA patients with inadequate control of the disease, IXE delivers consistent efficacy in several clinical domains of the disease regardless of concomitant MTX use. The efficacy of ADA is increased by the concomitant use of MTX. These findings can inform treatment decisions when considering the need for concomitant MTX use with IXE or ADA at initiation or for long-term maintenance. Electronic supplementary material The online version of this article (10.1007/s40744-020-00250-3) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 66%

“…For other musculoskeletal-related domains, the responses observed at week 24 were maintained until week 52. IXE efficacy on the combined ACR50 and PASI100 response, as well as on separately assessed ACR50 and PASI100 responses, were similar with or without csDMARDs, while response to ADA seemed better with concomitant csDMARD use [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study

et al. 2020

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“…Even though pivotal studies for biologics evaluating psoriasis nowadays include active comparators, short-term use in these trials usually precludes meaningful analyses of the nails, as efficacy can usually not be evaluated before 3-6 months (3). Recent trials suggest that the maximum effect is not reached for up to 1 year, or even beyond (7)(8)(9)(10)(11).…”

Section: Introductionmentioning

confidence: 99%

Network meta-analysis comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis

Reich

Conrad²,

Kristensen³

et al. 2021

Journal of Dermatological Treatment

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Background: Nail psoriasis (NP) is common and of high importance in patients with psoriasis. Complete resolution of NP at week 24-26 is an unambiguous nail outcome accessible for indirect treatment comparison of biologics. Objective: To evaluate the comparative efficacy of approved biologics in achieving complete resolution of NP at week 24-26. Methods: A network meta-analysis (NMA) was conducted to indirectly compare the efficacy of six biologics in achieving complete resolution of NP at week 24-26 in patients with moderate-to-severe psoriasis and concomitant NP. Complete resolution of NP was defined as a score of zero on the Nail Psoriasis Severity Index (NAPSI), modified NAPSI (mNAPSI) or Physician's Global Assessment of Fingernails (PGA-F). Results: The probability of achieving complete resolution of NP was highest for ixekizumab (46.

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“…Результаты РКИ SPIIRIT H2H неоднократно обсуждались на заседаниях Американской коллегии ревматологов в ноябре 2019 г. и Европейской антиревматической лиги в июне 2020 г. и недавно были опубликованы в ведущем ревматологическом издании -Annals of the Rheumatic Diseases [26].…”

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Results of direct comparison of the clinical efficacy of ixekizumab and adalimumab: data from the SPIRIT H2H study

Коротаева¹

2020

Sovremennaâ revmatologiâ

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Objective: to analyze the data available in the literature on the efficacy and safety of ixekizumab (IXE) and adalimumab (ADA) via their direct comparisons in the treatment of psoriatic arthritis (PsA).Patients and methods. The results of the SPIRIT H2H study were analyzed, the aim of which was to investigate the potential superiority of IXE to ADA for arthritis and skin manifestations in a group of patients with active PsA, stable plaque psoriasis with an inadequate response to synthetic disease-modifying antirheumatic drugs (sDMARDs) who had not previously received biological agents (BAs).Design: a 52-week multicenter, randomized, parallel-group study. The patients were randomized 1:1 to open IXE or ADA administration groups for 52 weeks. This review presents the data obtained at 24-week follow-up.Of the 684 screened patients, 566 (82.7%) were included in the study; moreover, the distribution of the patients was equal between the ADA (n=283) and IXE (n=283) groups. At 6 months, 269 (95%) patients in the ADA group and 262 (93%) in the IXE one continued to participate in the study. Efficacy analysis was made based on the achievement of the primary endpoint that was considered to be related to the relative number of patients, who had simultaneously achieved improvements in the joints and skin according to the ACR50 and PASI100 criteria.Results and discussion. At 24 weeks, the proportion of patients who had simultaneously achieved ACR50 and PASI100 responses was significantly higher in the IXE group (36%) than in the ADA one (28%) (p=0.036). It was found that the IXE group was not inferior to the ADA one in terms of ACR50 response rates (in 51% (IXE) and 47% (ADA) patients) and was superior in achieving PASI100 response rates (in 60% (IXE) and 47% (ADA) patients) (p=0.001). The IXE group was recorded to have a higher response than the ADA group and in terms of other manifestations of the disease: the severity of skin and nail psoriasis, enthesitis, remission achievement, minimal and very low disease activity, and improved quality of life. Comparable effectiveness was noted for the effect of the drugs on dactylitis, as well as for the simultaneous achievement of remission and low disease activity in psoriatic arthritis according DAPSA. Serious adverse events (SAEs) were recorded in 8.5% (ADA) and 3.5% (IXE) patients.The safety and tolerability of both BAs corresponded to their previously presented safety profile. The findings were also confirmed at 52-week follow-up, presented at the Meetings of the American College of Rheumatology in November 2019 and the European League Against Rheumatism in June 2020, and published in the leading journals of rheumatology.Conclusion. The first randomized placebo-controlled study (SPIRIT H2H) directly comparing the two BAs with different mechanisms of action demonstrated the advantage of IXE over ADA in simultaneously reducing the activity of arthritis and psoriasis and showed their comparable efficacy comparable efficacy regarding joint symptoms. The use of IXE versus ADA was accompanied by the more frequent achievement of a combined endpoint related to the signs of joint and skin damages in patients with PSA, as well as by the quantitatively lower frequency of SAEs in patients with active PSA who had failed previous sDMARD therapy. The findings are of great importance for clinical practice from the point of view of the reasonable choice of a treatment strategy in these patients.

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Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52

Cited by 68 publications

References 15 publications

Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study

Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study

Network meta-analysis comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis

Results of direct comparison of the clinical efficacy of ixekizumab and adalimumab: data from the SPIRIT H2H study

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