Browsing by Author "Ritchlin, Christopher T."

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    Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1
    (BMJ, 2017-01) Mease, Philip J.; van der Heijde, Désirée; Ritchlin, Christopher T.; Okada, Masato; Cuchacovich, Raquel S.; Shuler, Catherine L.; Lin, Chen-Yen; Braun, Daniel K.; Lee, Chin H.; Gladman, Dafna D.; Department of Medicine, IU School of Medicine
    OBJECTIVE: To assess the safety and efficacy of ixekizumab, a monoclonal antibody that inhibits interleukin-17A, in a double-blind phase III trial enrolling patients with active psoriatic arthritis (PsA). METHODS: Patients naive to biologic therapy with active PsA were randomised to subcutaneous injections of placebo (N=106), adalimumab 40 mg once every 2 weeks (active reference; N=101), ixekizumab 80 mg once every 2 weeks (IXEQ2W) (N=103), or ixekizumab 80 mg once every 4 weeks (IXEQ4W) (N=107). Both ixekizumab regimens included a 160-mg starting dose. The primary objective was to assess the superiority of IXEQ2W or IXEQ4W versus placebo as measured by the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response at week 24. RESULTS: Significantly more patients treated with ixekizumab achieved an ACR20 response with IXEQ2W (62.1%) or IXEQ4W (57.9%) than placebo (30.2%) (p≤0.001; non-responder imputation method). Disease activity and functional disability were significantly improved with both ixekizumab doses versus placebo at weeks 12 and 24, and there was significantly less progression of structural damage at week 24 (p≤0.01). Clearance of plaque psoriasis was greater with ixekizumab than placebo (p≤0.001). Efficacy results with adalimumab, the active reference arm, showed significant improvements versus placebo. Treatment-emergent adverse events were more frequent with ixekizumab (65.7-66.4%) and adalimumab (64.4%) than placebo (47.2%) (p<0.05). CONCLUSIONS: In biologic-naive patients with active PsA, ixekizumab treatment resulted in improvements in disease activity and physical function, as well as in the inhibition of structural damage progression. Overall, adverse events were more frequent in all active groups compared with placebo.
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    National Psoriasis Foundation COVID-19 Task Force Guidance for Management of Psoriatic Disease During the Pandemic: Version 1
    (Elsevier, 2020) Gelfand, Joel M.; Armstrong, April W.; Bell, Stacie; Anesi, George L.; Blauvelt, Andrew; Calabrese, Cassandra; Dommasch, Erica D.; Feldman, Steve R.; Gladman, Dafna; Kircik, Leon; Lebwohl, Mark; Lo Re, Vincent, III; Martin, George; Merola, Joseph F.; Scher, Jose U.; Schwartzman, Sergio; Treat, James R.; Van Voorhees, Abby S.; Ellebrecht, Christoph T.; Fenner, Justine; Ocon, Anthony; Syed, Maha N.; Weinstein, Erica J.; Smith, Jessica; Gondo, George; Heydon, Sue; Koons, Samantha; Ritchlin, Christopher T.; Medicine, School of Medicine
    Objective To provide guidance about management of psoriatic disease during the coronavirus disease 2019 (COVID-19) pandemic. Study design A task force (TF) of 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care was convened. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation (NPF) staff. Clinical questions relevant to the psoriatic disease community were informed by questions received by the NPF. A Delphi process was conducted. Results The TF approved 22 guidance statements. The average of the votes was within the category of agreement for all statements. All guidance statements proposed were recommended, 9 with high consensus and 13 with moderate consensus. Limitations The evidence behind many guidance statements is limited in quality. Conclusion These statements provide guidance for the management of patients with psoriatic disease on topics ranging from how the disease and its treatments impact COVID-19 risk and outcome, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with severe acute respiratory syndrome coronavirus 2 and what they should do if they develop COVID-19. The guidance is intended to be a living document that will be updated by the TF as data emerge.
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    National Psoriasis Foundation COVID-19 Task Force guidance for management of psoriatic disease during the pandemic: Version 2—Advances in psoriatic disease management, COVID-19 vaccines, and COVID-19 treatments
    (Elsevier, 2021-05) Gelfand, Joel M.; Armstrong, April W.; Bell, Stacie; Anesi, George L.; Blauvelt, Andrew; Calabrese, Cassandra; Dommasch, Erica D.; Feldman, Steven R.; Gladman, Dafna; Kircik, Leon; Lebwohl, Mark; Lo Re, Vincent, III; Martin, George; Merola, Joseph F.; Scher, Jose U.; Schwartzman, Sergio; Treat, James R.; Van Voorhees, Abby S.; Ellebrecht, Christoph T.; Fenner, Justine; Ocon, Anthony; Syed, Maha N.; Weinstein, Erica J.; Gondo, George; Heydon, Sue; Koons, Samantha; Ritchlin, Christopher T.; Dermatology, School of Medicine
    Objective To update guidance regarding the management of psoriatic disease during the COVID-19 pandemic. Study Design The task force (TF) includes 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation staff. Clinical questions relevant to the psoriatic disease community were informed by inquiries received by the National Psoriasis Foundation. A Delphi process was conducted. Results The TF updated evidence for the original 22 statements and added 5 new recommendations. The average of the votes was within the category of agreement for all statements, 13 with high consensus and 14 with moderate consensus. Limitations The evidence behind many guidance statements is variable in quality and/or quantity. Conclusions These statements provide guidance for the treatment of patients with psoriatic disease on topics including how the disease and its treatments affect COVID-19 risk, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with severe acute respiratory syndrome coronavirus 2 (including novel vaccination), and what they should do if they develop COVID-19. The guidance is a living document that is continuously updated by the TF as data emerge.