TY - JOUR
T1 - Recapture and retreatment rates with ixekizumab after withdrawal of therapy in patients with axial spondyloarthritis
T2 - Results at week 104 from a randomised placebo-controlled withdrawal study
AU - Landewé, Robert B. M.
AU - Poddubnyy, Denis
AU - Rahman, Proton
AU - van den Bosch, Filip E.
AU - Bolce, Rebecca
AU - Liu Leage, Soyi
AU - Lisse, Jeffrey R.
AU - Park, So Young
AU - Gensler, Lianne
N1 - Funding Information: RBML reports grants or contracts from AbbVie, Galapagos, Pfizer and UCB; personal fees from AbbVie, Celgene, Eli Lilly and Company, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB; consulting fees from Rheumatology Consultancy; and is a EULAR council member. DP reports grants or contracts from AbbVie, Eli Lilly and Company, MSD, Novartis and Pfizer; personal fees from AbbVie, Biocad, Eli Lilly and Company, Gilead, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer, Samsung Bioepis and UCB; and speaking fees and/or honoraria from AbbVie, Bristol Myers Squibb, Eli Lilly and Company, MSD, Novartis, Pfizer and UCB. PR reports research grants from Janssen and Novartis; speaking fees and/or honoraria from Abbott, AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis and Pfizer; travel support from Janssen; and participated on an advisory board for Abbott, AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis and Pfizer. FEVdB reports grant support from Merck and consulting fees from AbbVie, Amgen and Eli Lilly and Company. RB, SLL, JRL and SYP are employees of Eli Lilly and Company and own stock or stock options. LG reports grants or contracts from Novartis and Pfizer; personal fees from AbbVie, Galapagos, Janssen, Eli Lilly and Company, Pfizer, UCB and Galapagos; and participates in a leadership or fiduciary role in ACR, SPARTAN and ASAS. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022
Y1 - 2022
N2 - Objectives: To evaluate the recapture of response with open-label (OL) ixekizumab (IXE) retreatment at week 104 in patients with axial spondyloarthritis who flared after withdrawal of IXE therapy. Methods: COAST-Y (NCT03129100) is a phase III extension study that included a double-blind, placebo-controlled, randomised withdrawal-retreatment period (RWRP). Patients who achieved remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 (inactive disease, ID) at least once at week 16 or 20 and <2.1 (low disease activity, LDA) at both visits) were randomised 2:1 at week 24 to continue IXE or withdraw to placebo. Patients who subsequently flared were switched to OL IXE every 2 or 4 weeks (Q2W or Q4W) at the next visit. The proportions of patients who recaptured ASDAS LDA and ID were summarised for those who experienced flare. Results: Of the 155 patients who entered the RWRP (placebo, n=53; IXE Q4W, n=48; IXE Q2W, n=54), 138 (89%) completed week 104. Of the placebo-Treated patients (n=53), 28 (53%) experienced a flare during weeks 24-104; of these, 4 (14%) recaptured ASDAS LDA before retreatment with OL IXE, and 23 (82%) recaptured ASDAS LDA and 19 (68%) met ASDAS ID after retreatment. Of the continuously treated IXE patients (n=102), 13 experienced flare; 7 of 13 (54%) recaptured ASDAS LDA before switching to OL IXE retreatment, while 5 of 13 (38%) recaptured ASDAS LDA and 4 of 13 (31%) met ID after switching. Conclusions: Ninety-six per cent of patients withdrawn to placebo recaptured at least ASDAS LDA and 71% recaptured ASDAS ID with IXE retreatment at week 104. This may provide support to patients who may require a brief interruption in therapy.
AB - Objectives: To evaluate the recapture of response with open-label (OL) ixekizumab (IXE) retreatment at week 104 in patients with axial spondyloarthritis who flared after withdrawal of IXE therapy. Methods: COAST-Y (NCT03129100) is a phase III extension study that included a double-blind, placebo-controlled, randomised withdrawal-retreatment period (RWRP). Patients who achieved remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 (inactive disease, ID) at least once at week 16 or 20 and <2.1 (low disease activity, LDA) at both visits) were randomised 2:1 at week 24 to continue IXE or withdraw to placebo. Patients who subsequently flared were switched to OL IXE every 2 or 4 weeks (Q2W or Q4W) at the next visit. The proportions of patients who recaptured ASDAS LDA and ID were summarised for those who experienced flare. Results: Of the 155 patients who entered the RWRP (placebo, n=53; IXE Q4W, n=48; IXE Q2W, n=54), 138 (89%) completed week 104. Of the placebo-Treated patients (n=53), 28 (53%) experienced a flare during weeks 24-104; of these, 4 (14%) recaptured ASDAS LDA before retreatment with OL IXE, and 23 (82%) recaptured ASDAS LDA and 19 (68%) met ASDAS ID after retreatment. Of the continuously treated IXE patients (n=102), 13 experienced flare; 7 of 13 (54%) recaptured ASDAS LDA before switching to OL IXE retreatment, while 5 of 13 (38%) recaptured ASDAS LDA and 4 of 13 (31%) met ID after switching. Conclusions: Ninety-six per cent of patients withdrawn to placebo recaptured at least ASDAS LDA and 71% recaptured ASDAS ID with IXE retreatment at week 104. This may provide support to patients who may require a brief interruption in therapy.
KW - Antirheumatic Agents
KW - Biological Therapy
KW - Immune System Diseases
KW - Spondylitis, Ankylosing
UR - http://www.scopus.com/inward/record.url?scp=85139825192&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/ard-2022-222731
DO - https://doi.org/10.1136/ard-2022-222731
M3 - Article
C2 - 36100350
SN - 0003-4967
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
M1 - 222731
ER -