Submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programs
TREMFYA® is the only IL-23 inhibitor to demonstrate strong endoscopic outcomes with subcutaneous (SC) induction, consistent with intravenous (IV) induction, and has the potential to be the first in its class to offer the option of both SC and IV induction therapy in Crohn’s disease
GALAXI includes data demonstrating superior outcomes for TREMFYA® versus STELARA® (ustekinumab) in Crohn’s disease
SPRING HOUSE, PA, USA I June 20, 2024 I Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease. This marks the second submission to the FDA for TREMFYA® in inflammatory bowel disease this year following an application in March for moderately to severely active ulcerative colitis.a
The latest submission includes results from the Phase 3 GALAXI program,1 which was featured as a late-breaking oral presentation at Digestive Disease Week (DDW) 2024 last month.2 The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head trials to demonstrate superiority versus ustekinumab in Crohn’s disease.2 TREMFYA® successfully met the co-primary endpoints for both SC maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) compared to placebo in each individual study and demonstrated superiority to ustekinumab in multiplicity-controlled endoscopic endpoints based on data pooled from both studies.2
The submission also includes results from the Phase 3 GRAVITI investigational study of TREMFYA ® SC induction therapy in adult patients with moderately to severely active Crohn’s disease,3 which met the co-primary endpoints, achieving statistically significant and clinically meaningful outcomes for clinical remission at Week 12 as well as endoscopic response at Week 12. In addition, all multiplicity-controlled endpoints were met compared to placebo at Week 12, Week 24 and Week 48.4 The results from GALAXI and GRAVITI show that TREMFYA® has the potential to become the only IL-23 inhibitor to offer both subcutaneous or intravenous induction options for the treatment of Crohn’s disease, and, if approved, will offer choice and versatility for patients and providers.2,4
“Building upon nearly three decades of leadership and innovation in immunology, we are committed to addressing the needs of people living with Crohn’s disease through deep, scientific expertise and through our continued pioneering advances in the IL-23 pathway,” said David Lee, M.D., Ph.D., Global Therapeutic Area Head Immunology, Johnson & Johnson Innovative Medicine. “TREMFYA has the potential to be a differentiated treatment option for patients who seek symptom relief and sustained remission. We look forward to working with the Agency in their review of the data supporting the application as we continue to innovate for people living with inflammatory bowel disease.”
TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23.5 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including Crohn’s disease.6 TREMFYA®, the first-in-class IL-23 inhibitor, received U.S. FDA approval in July 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis and was subsequently approved for adults with active psoriatic arthritis in July 2020.5
Janssen-Cilag International NV, a Johnson & Johnson company, previously announced the submission of applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA® to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.
Editor’s Notes:
a. TREMFYA® is not approved to treat ulcerative colitis or Crohn’s disease.
ABOUT THE GALAXI PROGRAM (NCT03466411)
GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab).1 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).1 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomized and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years. Participants randomized to placebo were able to receive ustekinumab if clinical response was not met at Week 12. 1
ABOUT THE GRAVITI PROGRAM (NCT05197049)
GRAVITI is a randomized, double-blind, placebo-controlled Phase 3 study to evaluate guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in patients with moderately to severely active Crohn’s disease who experienced an inadequate response or failed to tolerate conventional therapy (i.e., corticosteroids or immunomodulators) or biologic therapy (TNF antagonists or vedolizumab).3 The maintenance doses in GRAVITI are the same as those evaluated in GALAXI (200 mg SC q4w and 100 mg SC q8w).3 The study employed a treat-through design, in which patients are randomized to guselkumab at Week 0 and remain on that regimen throughout the study, regardless of clinical response status at the end of induction.3 Participants randomized to placebo were able to receive guselkumab (400 mg SC q4w x3 ➔ 100 mg SC q8w) if rescue criteria were met at Week 16.3
ABOUT CROHN’S DISEASE
Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe.7,8 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.9 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn’s disease.10
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody that blocks IL-23 by binding to the p19 subunit of IL-23 and binding to CD64, a receptor on cells that produce IL-23.3 IL-23 is an important driver of the pathogenesis of inflammatory diseases.5 Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.11,12,13,14
TREMFYA® is approved in the U.S.,5 Canada,15 Japan16 and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active psoriatic arthritis (PsA).17 It is also approved in the EU for the treatment of moderate-to-severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.17
Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®.
Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1–800–FDA–1088.
ABOUT STELARA® (ustekinumab)
STELARA® (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children six years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adults and children six years and older with active psoriatic arthritis; 3) adult patients (18 years and older) with moderately to severely active Crohn’s disease; 4) adult patients (18 years and older) with moderately to severely active ulcerative colitis.18
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.
Please click to read the full Prescribing Information and Medication Guide for STELARA® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1–800–FDA–1088.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.janssen.com/johnson-johnson-innovative-medicine. Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen-Cilag International NV are Johnson & Johnson companies.
- National Institutes of Health: Clinicaltrials.gov. A study of the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease (GALAXI). Identifier: NCT03466411. Available at: https://clinicaltrials.gov/study/NCT03466411. Accessed June 2024.
- Panaccione, R et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn’s disease: results of the GALAXI 2 & 3 Phase 3 studies. Oral presentation (Abstract #1057b) at Digestive Disease Week (DDW) 2024. May 2024.
- National Institutes of Health: Clinicaltrials.gov. A study of guselkumab subcutaneous therapy in participants with moderately to severely active Crohn’s disease (GRAVITI). Identifier: NCT05197049. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT05197049. Accessed June 2024.
- Data on file. Guselkumab. Clinical study report CNTO1959CRD3004 (GRAVITI).
- US Food and Drug Administration. TREMFYA® prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s007lbl.pdf. Accessed June 2024.
- Schinocca, C. et al. Role of the IL-23/IL-17 pathway in rheumatic diseases: an overview. Frontiers in immunology. 2021 Feb 22;12:321. Available at: https://doi.org/10.3389/fimmu.2021.637829. Accessed June 2024.
- Crohn’s & Colitis Foundation. Overview of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed June 2024.
- Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78.
- Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed June 2024.
- Crohn’s & Colitis Foundation. Signs and symptoms of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms. Accessed June 2024.
- Mehta H, et al. Differential changes in inflammatory mononuclear phagocyte and T-Cell profiles within psoriatic skin during treatment with guselkumab vs. secukinumab. J Invest Dermatol 2021;141(7):1707-1718. Available at: https://pubmed.ncbi.nlm.nih.gov/33524368/. Accessed June 2024.
- Wang Y, et al. Monocytes/Macrophages play a pathogenic role in IL-23 mediated psoriasis-like skin inflammation. Sci Rep. 2019;9(1):5310. Available at: https://pubmed.ncbi.nlm.nih.gov/30926837/. Accessed June 2024.
- Matt P, et al. Up-regulation of CD64-expressing monocytes with impaired FcγR function reflects disease activity in polyarticular psoriatic arthritis. Scand J Rheumatol 2015; 44(6):464-473. Available at: https://pubmed.ncbi.nlm.nih.gov/26084203/. Accessed June 2024.
- McGonagle D, et al. Guselkumab, an IL-23p19 subunit–specific monoclonal antibody, binds CD64+ myeloid cells and potently neutralises IL-23 produced from the same cells. Presented at EULAR 2023, May 31-June 3.
- The Canadian Agency for Drugs & Technologies in Health. TREMFYA® prescribing information. Available at: https://www.cadth.ca/guselkumab-0. Accessed June 2024.
- Japan Pharmaceuticals and Medical Devices Agency. Tremfya report on the deliberation results. Available at: https://www.pmda.go.jp/files/000234741.pdf. Accessed June 2024.
- European Commission: Tremfya (guselkumab). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya. Accessed June 2024.
- US Food and Drug Administration. STELARA® prescribing information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf. Accessed June 2024.
SOURCE: Johnson & Johnson
Post Views: 1,208
Submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programs
TREMFYA® is the only IL-23 inhibitor to demonstrate strong endoscopic outcomes with subcutaneous (SC) induction, consistent with intravenous (IV) induction, and has the potential to be the first in its class to offer the option of both SC and IV induction therapy in Crohn’s disease
GALAXI includes data demonstrating superior outcomes for TREMFYA® versus STELARA® (ustekinumab) in Crohn’s disease
SPRING HOUSE, PA, USA I June 20, 2024 I Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease. This marks the second submission to the FDA for TREMFYA® in inflammatory bowel disease this year following an application in March for moderately to severely active ulcerative colitis.a
The latest submission includes results from the Phase 3 GALAXI program,1 which was featured as a late-breaking oral presentation at Digestive Disease Week (DDW) 2024 last month.2 The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head trials to demonstrate superiority versus ustekinumab in Crohn’s disease.2 TREMFYA® successfully met the co-primary endpoints for both SC maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) compared to placebo in each individual study and demonstrated superiority to ustekinumab in multiplicity-controlled endoscopic endpoints based on data pooled from both studies.2
The submission also includes results from the Phase 3 GRAVITI investigational study of TREMFYA ® SC induction therapy in adult patients with moderately to severely active Crohn’s disease,3 which met the co-primary endpoints, achieving statistically significant and clinically meaningful outcomes for clinical remission at Week 12 as well as endoscopic response at Week 12. In addition, all multiplicity-controlled endpoints were met compared to placebo at Week 12, Week 24 and Week 48.4 The results from GALAXI and GRAVITI show that TREMFYA® has the potential to become the only IL-23 inhibitor to offer both subcutaneous or intravenous induction options for the treatment of Crohn’s disease, and, if approved, will offer choice and versatility for patients and providers.2,4
“Building upon nearly three decades of leadership and innovation in immunology, we are committed to addressing the needs of people living with Crohn’s disease through deep, scientific expertise and through our continued pioneering advances in the IL-23 pathway,” said David Lee, M.D., Ph.D., Global Therapeutic Area Head Immunology, Johnson & Johnson Innovative Medicine. “TREMFYA has the potential to be a differentiated treatment option for patients who seek symptom relief and sustained remission. We look forward to working with the Agency in their review of the data supporting the application as we continue to innovate for people living with inflammatory bowel disease.”
TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23.5 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including Crohn’s disease.6 TREMFYA®, the first-in-class IL-23 inhibitor, received U.S. FDA approval in July 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis and was subsequently approved for adults with active psoriatic arthritis in July 2020.5
Janssen-Cilag International NV, a Johnson & Johnson company, previously announced the submission of applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA® to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.
Editor’s Notes:
a. TREMFYA® is not approved to treat ulcerative colitis or Crohn’s disease.
ABOUT THE GALAXI PROGRAM (NCT03466411)
GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab).1 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3).1 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomized and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years. Participants randomized to placebo were able to receive ustekinumab if clinical response was not met at Week 12. 1
ABOUT THE GRAVITI PROGRAM (NCT05197049)
GRAVITI is a randomized, double-blind, placebo-controlled Phase 3 study to evaluate guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in patients with moderately to severely active Crohn’s disease who experienced an inadequate response or failed to tolerate conventional therapy (i.e., corticosteroids or immunomodulators) or biologic therapy (TNF antagonists or vedolizumab).3 The maintenance doses in GRAVITI are the same as those evaluated in GALAXI (200 mg SC q4w and 100 mg SC q8w).3 The study employed a treat-through design, in which patients are randomized to guselkumab at Week 0 and remain on that regimen throughout the study, regardless of clinical response status at the end of induction.3 Participants randomized to placebo were able to receive guselkumab (400 mg SC q4w x3 ➔ 100 mg SC q8w) if rescue criteria were met at Week 16.3
ABOUT CROHN’S DISEASE
Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe.7,8 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.9 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn’s disease.10
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody that blocks IL-23 by binding to the p19 subunit of IL-23 and binding to CD64, a receptor on cells that produce IL-23.3 IL-23 is an important driver of the pathogenesis of inflammatory diseases.5 Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.11,12,13,14
TREMFYA® is approved in the U.S.,5 Canada,15 Japan16 and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active psoriatic arthritis (PsA).17 It is also approved in the EU for the treatment of moderate-to-severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.17
Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®.
Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1–800–FDA–1088.
ABOUT STELARA® (ustekinumab)
STELARA® (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children six years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adults and children six years and older with active psoriatic arthritis; 3) adult patients (18 years and older) with moderately to severely active Crohn’s disease; 4) adult patients (18 years and older) with moderately to severely active ulcerative colitis.18
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.
Please click to read the full Prescribing Information and Medication Guide for STELARA® and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1–800–FDA–1088.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.janssen.com/johnson-johnson-innovative-medicine. Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen-Cilag International NV are Johnson & Johnson companies.
- National Institutes of Health: Clinicaltrials.gov. A study of the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease (GALAXI). Identifier: NCT03466411. Available at: https://clinicaltrials.gov/study/NCT03466411. Accessed June 2024.
- Panaccione, R et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn’s disease: results of the GALAXI 2 & 3 Phase 3 studies. Oral presentation (Abstract #1057b) at Digestive Disease Week (DDW) 2024. May 2024.
- National Institutes of Health: Clinicaltrials.gov. A study of guselkumab subcutaneous therapy in participants with moderately to severely active Crohn’s disease (GRAVITI). Identifier: NCT05197049. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT05197049. Accessed June 2024.
- Data on file. Guselkumab. Clinical study report CNTO1959CRD3004 (GRAVITI).
- US Food and Drug Administration. TREMFYA® prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s007lbl.pdf. Accessed June 2024.
- Schinocca, C. et al. Role of the IL-23/IL-17 pathway in rheumatic diseases: an overview. Frontiers in immunology. 2021 Feb 22;12:321. Available at: https://doi.org/10.3389/fimmu.2021.637829. Accessed June 2024.
- Crohn’s & Colitis Foundation. Overview of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed June 2024.
- Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78.
- Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed June 2024.
- Crohn’s & Colitis Foundation. Signs and symptoms of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms. Accessed June 2024.
- Mehta H, et al. Differential changes in inflammatory mononuclear phagocyte and T-Cell profiles within psoriatic skin during treatment with guselkumab vs. secukinumab. J Invest Dermatol 2021;141(7):1707-1718. Available at: https://pubmed.ncbi.nlm.nih.gov/33524368/. Accessed June 2024.
- Wang Y, et al. Monocytes/Macrophages play a pathogenic role in IL-23 mediated psoriasis-like skin inflammation. Sci Rep. 2019;9(1):5310. Available at: https://pubmed.ncbi.nlm.nih.gov/30926837/. Accessed June 2024.
- Matt P, et al. Up-regulation of CD64-expressing monocytes with impaired FcγR function reflects disease activity in polyarticular psoriatic arthritis. Scand J Rheumatol 2015; 44(6):464-473. Available at: https://pubmed.ncbi.nlm.nih.gov/26084203/. Accessed June 2024.
- McGonagle D, et al. Guselkumab, an IL-23p19 subunit–specific monoclonal antibody, binds CD64+ myeloid cells and potently neutralises IL-23 produced from the same cells. Presented at EULAR 2023, May 31-June 3.
- The Canadian Agency for Drugs & Technologies in Health. TREMFYA® prescribing information. Available at: https://www.cadth.ca/guselkumab-0. Accessed June 2024.
- Japan Pharmaceuticals and Medical Devices Agency. Tremfya report on the deliberation results. Available at: https://www.pmda.go.jp/files/000234741.pdf. Accessed June 2024.
- European Commission: Tremfya (guselkumab). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya. Accessed June 2024.
- US Food and Drug Administration. STELARA® prescribing information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf. Accessed June 2024.
SOURCE: Johnson & Johnson
Post Views: 1,208
