Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders. A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3)
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Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders. A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3). / Blauvelt, Andrew; Papp, Kim A; Griffiths, Christopher E M; Puig, Luis; Weisman, Jamie; Dutronc, Yves; Kerr, Lisa Farmer; Ilo, Dapo; Mallbris, Lotus; Augustin, Matthias.
in: AM J CLIN DERMATOL, Jahrgang 18, Nr. 2, 04.2017, S. 273-280.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders. A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3)
AU - Blauvelt, Andrew
AU - Papp, Kim A
AU - Griffiths, Christopher E M
AU - Puig, Luis
AU - Weisman, Jamie
AU - Dutronc, Yves
AU - Kerr, Lisa Farmer
AU - Ilo, Dapo
AU - Mallbris, Lotus
AU - Augustin, Matthias
PY - 2017/4
Y1 - 2017/4
N2 - BACKGROUND: Patients with psoriasis who have an inadequate response to one biologic may benefit from switching to a new biologic, such as ixekizumab, a high affinity monoclonal antibody that selectively targets interleukin (IL)-17A.OBJECTIVE: Our aim was to assess the response to ixekizumab in patients with moderate-to-severe plaque psoriasis who did not respond adequately to etanercept using a post-hoc analysis in two phase III studies.METHODS: For the subanalyses in two phase III trials (UNCOVER-2 and -3), non-response was defined by either failure to have a static physician global assessment (sPGA) of 0/1 in UNCOVER-2 or failure to have at least 75% improvement in psoriasis area and severity index (PASI 75) in UNCOVER-3 at Week 12 of each study. Non-responders treated with twice-weekly etanercept 50 mg in the first 12 weeks received two injections of placebo at Week 12 (4-week wash-out period), followed by ixekizumab every 4 weeks (Q4W) for Weeks 16-60. Non-responders to placebo in the first 12 weeks were administered ixekizumab 160 mg at Week 12, followed by ixekizumab Q4W for Weeks 16-60.RESULTS: After switching to ixekizumab Q4W, a substantial proportion of patients with moderate-to-severe psoriasis who did not respond to etanercept experienced rapid and durable improvement in all efficacy evaluations. Among sPGA 0/1 (UNCOVER-2) and PASI 75 (UNCOVER-3) non-responders to etanercept, 73.0% achieved sPGA 0/1 and 78.2% achieved PASI 75, respectively, after 12 weeks of ixekizumab treatment. Safety profiles in patients switched from etanercept to ixekizumab were similar to those in patients switched from placebo to ixekizumab.CONCLUSION: Patients who were non-responders to etanercept after 12 weeks, as defined by failure to meet sPGA 0/1 (UNCOVER-2) or PASI 75 (UNCOVER-3), achieved high levels of response 12 weeks after switching to ixekizumab. Studies are registered with ClinicalTrials.gov (NCT01597245 and NCT01646177).
AB - BACKGROUND: Patients with psoriasis who have an inadequate response to one biologic may benefit from switching to a new biologic, such as ixekizumab, a high affinity monoclonal antibody that selectively targets interleukin (IL)-17A.OBJECTIVE: Our aim was to assess the response to ixekizumab in patients with moderate-to-severe plaque psoriasis who did not respond adequately to etanercept using a post-hoc analysis in two phase III studies.METHODS: For the subanalyses in two phase III trials (UNCOVER-2 and -3), non-response was defined by either failure to have a static physician global assessment (sPGA) of 0/1 in UNCOVER-2 or failure to have at least 75% improvement in psoriasis area and severity index (PASI 75) in UNCOVER-3 at Week 12 of each study. Non-responders treated with twice-weekly etanercept 50 mg in the first 12 weeks received two injections of placebo at Week 12 (4-week wash-out period), followed by ixekizumab every 4 weeks (Q4W) for Weeks 16-60. Non-responders to placebo in the first 12 weeks were administered ixekizumab 160 mg at Week 12, followed by ixekizumab Q4W for Weeks 16-60.RESULTS: After switching to ixekizumab Q4W, a substantial proportion of patients with moderate-to-severe psoriasis who did not respond to etanercept experienced rapid and durable improvement in all efficacy evaluations. Among sPGA 0/1 (UNCOVER-2) and PASI 75 (UNCOVER-3) non-responders to etanercept, 73.0% achieved sPGA 0/1 and 78.2% achieved PASI 75, respectively, after 12 weeks of ixekizumab treatment. Safety profiles in patients switched from etanercept to ixekizumab were similar to those in patients switched from placebo to ixekizumab.CONCLUSION: Patients who were non-responders to etanercept after 12 weeks, as defined by failure to meet sPGA 0/1 (UNCOVER-2) or PASI 75 (UNCOVER-3), achieved high levels of response 12 weeks after switching to ixekizumab. Studies are registered with ClinicalTrials.gov (NCT01597245 and NCT01646177).
KW - Adult
KW - Anti-Inflammatory Agents, Non-Steroidal
KW - Antibodies, Monoclonal, Humanized
KW - Drug Substitution
KW - Etanercept
KW - Female
KW - Humans
KW - Interleukin-17
KW - Male
KW - Middle Aged
KW - Psoriasis
KW - Severity of Illness Index
KW - Treatment Failure
KW - Treatment Outcome
KW - Clinical Trial, Phase III
KW - Journal Article
KW - Randomized Controlled Trial
U2 - 10.1007/s40257-016-0246-9
DO - 10.1007/s40257-016-0246-9
M3 - SCORING: Journal article
C2 - 28074446
VL - 18
SP - 273
EP - 280
JO - AM J CLIN DERMATOL
JF - AM J CLIN DERMATOL
SN - 1175-0561
IS - 2
ER -
