Efficacy and Safety of Ixekizumab in Patients with Psoriatic
Arthritis and Inadequate Response to TNF Inhibitors: 3-Year
Follow-Up (SPIRIT-P2)

J 2020

Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)

ORBAI, A.M., J. GRATACOS, A. TURKIEWICZ, S. HALL, Eva DOKOUPILOVÁ et. al.

Basic information

Original name

Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)

Authors

ORBAI, A.M. (guarantor), J. GRATACOS, A. TURKIEWICZ, S. HALL, Eva DOKOUPILOVÁ (203 Czech Republic, belonging to the institution), B. COMBE, P. NASH, G. GALLO, C.C. BERTRAM, A.M. GELLETT, A.T. SPRABERY, J. BIRT, L. MACPHERSON, V.J. GENEUS and A. CONSTANTIN

Edition

RHEUMATOLOGY AND THERAPY, NEW YORK, SPRINGER, 2020, 2198-6576

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30104 Pharmacology and pharmacy

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 3.494

RIV identification code

RIV/00216224:14160/20:00124428

Organization unit

Faculty of Pharmacy

DOI

http://dx.doi.org/10.1007/s40744-020-00261-0

UT WoS

000599046000001

Keywords in English

Efficacy; Interleukin-17A; Ixekizumab; Psoriatic arthritis; Safety

Abstract

V originále

Purpose Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A. The objective of this study was to assess the long-term efficacy and safety (to week 156) of ixekizumab in patients with active psoriatic arthritis and inadequate response or intolerance to one or two tumor necrosis factor inhibitors. Methods In the SPIRIT-P2 study (ClinicalTrials.gov ID: NCT02349295), patients were randomized to placebo or ixekizumab 80 mg every 4 weeks (IXE Q4W) or every 2 weeks (IXE Q2W) following a 160-mg starting dose. During the extension period (weeks 24-156), patients maintained their original ixekizumab dose, and placebo patients received IXE Q4W or IXE Q2W (1:1). Exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) are presented. Results Of 363 patients enrolled in the study, 310 entered the extension period. In all patients treated with IXE Q4W and IXE Q2W at week 0, responses persisted to week 156. At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed MDA. Placebo patients re-randomized to ixekizumab also demonstrated sustained efficacy, as measured by ACR and MDA responses. In the All Ixekizumab Exposure Safety Population (n = 337), with 644 PY of ixekizumab exposure, treatment-emergent adverse events (TEAEs) were reported by 286 patients (44.4 IR). The most common TEAEs were upper respiratory tract infection (9.80 IR), nasopharyngitis (8.2 IR), sinusitis (6.2 IR), and bronchitis (4.5 IR). Serious adverse events were reported by 42 (6.5 IR) patients (included 3 deaths and 10 infections). Conclusion In this 156-week study of ixekizumab, improvements in signs and symptoms of psoriatic arthritis and the safety profile remained consistent with those in previous reports.

Citovat

ORBAI, A.M., J. GRATACOS, A. TURKIEWICZ, S. HALL, Eva DOKOUPILOVÁ, B. COMBE, P. NASH, G. GALLO, C.C. BERTRAM, A.M. GELLETT, A.T. SPRABERY, J. BIRT, L. MACPHERSON, V.J. GENEUS and A. CONSTANTIN. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). RHEUMATOLOGY AND THERAPY. NEW YORK: SPRINGER, 2020, vol. 8, No 1, p. 199-217. ISSN 2198-6576. Available from: https://dx.doi.org/10.1007/s40744-020-00261-0.

@article{1842441,
   author = {Orbai, A.M. and Gratacos, J. and Turkiewicz, A. and Hall, S. and Dokoupilová, Eva and Combe, B. and Nash, P. and Gallo, G. and Bertram, C.C. and Gellett, A.M. and Sprabery, A.T. and Birt, J. and Macpherson, L. and Geneus, V.J. and Constantin, A.},
   article_location = {NEW YORK},
   article_number = {1},
   doi = {http://dx.doi.org/10.1007/s40744-020-00261-0},
   keywords = {Efficacy; Interleukin-17A; Ixekizumab; Psoriatic arthritis; Safety},
   language = {eng},
   issn = {2198-6576},
   journal = {RHEUMATOLOGY AND THERAPY},
   title = {Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)},
   url = {https://link.springer.com/article/10.1007/s40744-020-00261-0},
   volume = {8},
   year = {2020}
}

TY  - JOUR
ID  - 1842441
AU  - Orbai, A.M. - Gratacos, J. - Turkiewicz, A. - Hall, S. - Dokoupilová, Eva - Combe, B. - Nash, P. - Gallo, G. - Bertram, C.C. - Gellett, A.M. - Sprabery, A.T. - Birt, J. - Macpherson, L. - Geneus, V.J. - Constantin, A.
PY  - 2020
TI  - Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)
JF  - RHEUMATOLOGY AND THERAPY
VL  - 8
IS  - 1
SP  - 199-217
EP  - 199-217
PB  - SPRINGER
SN  - 21986576
KW  - Efficacy
KW  - Interleukin-17A
KW  - Ixekizumab
KW  - Psoriatic arthritis
KW  - Safety
UR  - https://link.springer.com/article/10.1007/s40744-020-00261-0
N2  - Purpose Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A. The objective of this study was to assess the long-term efficacy and safety (to week 156) of ixekizumab in patients with active psoriatic arthritis and inadequate response or intolerance to one or two tumor necrosis factor inhibitors. Methods In the SPIRIT-P2 study (ClinicalTrials.gov ID: NCT02349295), patients were randomized to placebo or ixekizumab 80 mg every 4 weeks (IXE Q4W) or every 2 weeks (IXE Q2W) following a 160-mg starting dose. During the extension period (weeks 24-156), patients maintained their original ixekizumab dose, and placebo patients received IXE Q4W or IXE Q2W (1:1). Exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) are presented. Results Of 363 patients enrolled in the study, 310 entered the extension period. In all patients treated with IXE Q4W and IXE Q2W at week 0, responses persisted to week 156. At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed MDA. Placebo patients re-randomized to ixekizumab also demonstrated sustained efficacy, as measured by ACR and MDA responses. In the All Ixekizumab Exposure Safety Population (n = 337), with 644 PY of ixekizumab exposure, treatment-emergent adverse events (TEAEs) were reported by 286 patients (44.4 IR). The most common TEAEs were upper respiratory tract infection (9.80 IR), nasopharyngitis (8.2 IR), sinusitis (6.2 IR), and bronchitis (4.5 IR). Serious adverse events were reported by 42 (6.5 IR) patients (included 3 deaths and 10 infections). Conclusion In this 156-week study of ixekizumab, improvements in signs and symptoms of psoriatic arthritis and the safety profile remained consistent with those in previous reports.
ER  -

ORBAI, A.M., J. GRATACOS, A. TURKIEWICZ, S. HALL, Eva DOKOUPILOVÁ, B. COMBE, P. NASH, G. GALLO, C.C. BERTRAM, A.M. GELLETT, A.T. SPRABERY, J. BIRT, L. MACPHERSON, V.J. GENEUS and A. CONSTANTIN. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). \textit{RHEUMATOLOGY AND THERAPY}. NEW YORK: SPRINGER, 2020, vol.~8, No~1, p.~199-217. ISSN~2198-6576. Available from: https://dx.doi.org/10.1007/s40744-020-00261-0.

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