FAQ: How Does Guselkumab Affect Pregnancy Outcomes?

In this medication review, Robert Casquejo discusses icotrokinra, an oral macrocyclic peptide that selectively targets the interleukin-23 (IL-23) receptor. He explains how IL-23 receptor inhibition affects the IL-23/Th17/IL-17 inflammatory pathway and explores the features that distinguish this oral treatment approach from injectable monoclonal antibodies used in psoriatic disease. This episode reviews psoriasis clinical trial findings, including Investigator’s Global Assessment (IGA) scores of clear or almost clear, 90% improvement in the Psoriasis Area and Severity Index (PASI 90), and longer-term treatment responses through 52 weeks. Robert also discusses reported safety findings, including upper respiratory tract infections and nasopharyngitis, along with practical considerations related to oral administration and medication absorption. The conversation considers how an oral treatment option may support discussions with patients who prefer to avoid injections. Designed for dermatology and rheumatology advanced practice providers, nurse practitioners, physician associates, pharmacists, and other healthcare professionals, this overview examines icotrokinra’s mechanism of action, psoriasis efficacy data, and safety profile. Robert also highlights ongoing clinical trials in psoriatic arthritis (PsA), distinguishing the psoriasis findings discussed from the research evaluating potential applications in joint disease. For more rheumatology education and clinical resources, visit RhAPP’s website, the RhAPP content rheum, or the RhAPP ACE app.

In this Medication Review video, Jennifer Mylod, DNP, discusses recent real-world evidence supporting the effectiveness and safety of belimumab in systemic lupus erythematosus (SLE). As one of the most established biologic therapies for lupus, belimumab continues to demonstrate meaningful benefits for patients across a range of clinical settings.This educational discussion reviews real-world data showing improvements in disease activity, flare reduction, serologic markers, and corticosteroid use among patients treated with belimumab. Jennifer also highlights findings from lupus nephritis studies, which have demonstrated improvements in proteinuria and renal response rates when belimumab is added to standard therapy.Watch now to learn more about the long-term safety and effectiveness of belimumab, including commonly reported adverse events and the reassuring safety profile observed since its approval more than 15 years ago. For more expert-led education, visit the Content Rheum and download the RhAPP Ace app to stay up to date with the latest clinical insights in rheumatologic care.

Stay up to date with the latest guidance in lupus nephritis management in this RhAPPcast episode featuring host Amanda Mixon, PA-C, and Tiffany Terrell, FNP-C. Through a practical case-based discussion, they explore how the latest American College of Rheumatology (ACR) guidelines can be applied in real-world clinical practice to support early detection, timely intervention, and long-term kidney preservation in patients with lupus nephritis.Learn about current recommendations for screening and monitoring patients with systemic lupus erythematosus (SLE), the role of kidney biopsy in diagnosis, and evolving treatment strategies for lupus nephritis. The discussion highlights guideline-directed approaches to therapy selection, treatment monitoring, response assessment, and management of refractory disease, while emphasizing the importance of preserving renal function and improving long-term outcomes.Whether you're a rheumatology provider, advanced practice provider (APP), or healthcare professional caring for patients with lupus, this episode provides practical insights into translating clinical guidelines into everyday practice and optimizing care for patients with lupus nephritis. For more expert-led education, visit the Content Rheum and download the RhAPP Ace app to stay up to date with the latest clinical insights in rheumatologic care.

In this special edition of RhAPPcast, the official podcast of Rheumatology Advanced Practice Providers (RhAPP), Heather Finlayson and Kevin Daley discuss rheumatology advocacy and the importance of strengthening the APP voice in healthcare policy. They introduce the RhAPP Advocacy Committee and explore how nurse practitioners, physician assistants, and pharmacists can get involved in addressing insurance barriers, supporting medication access, and advocating for their patients and practices.This episode highlights key advocacy issues in rheumatology, including step therapy, non-medical switching, prior authorization, prescription drug affordability boards (PDABs), and the federal 340B Drug Pricing Program. Heather and Kevin discuss how insurance requirements and policy decisions intersect with everyday patient care, sharing practical ways clinicians can participate through legislative outreach, letter writing, virtual testimony, and patient education. The conversation also explores payer advocacy and the importance of bringing clinical experiences and patient perspectives into state and federal policy discussions.Designed for rheumatology APPs and other healthcare professionals, this discussion outlines the committee’s plans for regional leadership, virtual meetings, and ongoing advocacy education. Whether you are new to healthcare advocacy or looking for ways to become more involved, this episode offers an approachable starting point for making your voice heard and helping patients do the same. For more rheumatology education and podcasts, visit RhAPP’s website and explore the RhAPP ACE app.

In this FAQ video module, William Saalfeld, NP, explains the rationale for investigational combination therapy with guselkumab and golimumab in psoriatic arthritis (PsA). He reviews how guselkumab targets interleukin-23 (IL-23) and golimumab inhibits tumor necrosis factor (TNF), highlighting how these medications address complementary inflammatory pathways involved in immune activation, synovitis, and joint inflammation.This episode examines the phase 2a AFFINITY study, which compared guselkumab plus golimumab with guselkumab monotherapy. William discusses the primary endpoint of minimal disease activity (MDA), American College of Rheumatology (ACR) response measures, and exploratory findings in patients with elevated C-reactive protein (CRP). He explains that the primary endpoint was not met, while secondary and exploratory analyses suggested potential additional benefits in peripheral joint disease and physical function. The discussion also considers why improvements in psoriasis, enthesitis, and dactylitis did not show a clear additional benefit with combination therapy.Designed for rheumatology advanced practice providers, nurse practitioners, physician assistants, and other healthcare professionals, this FAQ offers a concise overview of dual IL-23 and TNF inhibition in psoriatic arthritis. William emphasizes that guselkumab plus golimumab remains investigational, with further research needed to clarify which patients may benefit and its potential role in future PsA treatment strategies. For more expert-led education, visit the Content Rheum and download the RhAPP Ace app to stay up to date with the latest clinical insights in rheumatologic care.

In this FAQ video module, Candace Ryan, PA-C, reviews guselkumab and pregnancy outcomes in patients with psoriatic arthritis, psoriasis, and inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis. She discusses how the timing of exposure to this IL-23 inhibitor and changes in placental antibody transfer inform conversations about biologic therapy during pregnancy.This episode examines pregnancy safety findings from the Janssen Global Safety Database and a World Health Organization (WHO) pharmacovigilance analysis. Candace reviews reported miscarriages, congenital abnormalities, live births, and comparisons with TNF inhibitors, while explaining the limitations of observational data and spontaneous reporting. She emphasizes why reassuring findings do not establish guselkumab as definitively safe during pregnancy or demonstrate greater safety than TNF inhibitors, particularly given limited data on exposure later in pregnancy.The discussion also explores ACR and EULAR guidance on biologic use during pregnancy and the importance of balancing potential medication risks with the consequences of uncontrolled maternal inflammatory disease. Topics include disease severity, timing of exposure, alternative therapies compatible with pregnancy, and shared decision-making to individualize treatment.Designed for rheumatology advanced practice providers, nurse practitioners, physician assistants, and other healthcare professionals, this FAQ offers practical context for reproductive health counseling and treatment decisions involving guselkumab during pregnancy. For more rheumatology education and clinical resources, visit RhAPP’s website, the RhAPP content rheum, or the RhAPP ACE app.

In this Journal Club, Claudia Rivera-Salas, DNP, discusses the phase 2a AFFINITY trial evaluating combination therapy for active psoriatic arthritis (PsA). She reviews a randomized, double-blind study comparing guselkumab, an interleukin-23 (IL-23) inhibitor, plus golimumab, a tumor necrosis factor (TNF) inhibitor, with guselkumab alone in adults who had an inadequate response to prior TNF inhibitor treatment.This episode explores the week 24 results, including the study’s primary endpoint of minimal disease activity (MDA), which was not met. Claudia discusses exploratory secondary findings involving ACR20 and ACR50 responses and patient-reported physical health outcomes, along with subgroup findings in participants with elevated baseline C-reactive protein (CRP). She also reviews safety observations through week 36 and considers the questions these early results raise about targeting two inflammatory pathways simultaneously in patients with persistent psoriatic arthritis disease activity.Designed for rheumatology advanced practice providers, nurse practitioners, physician assistants, and other healthcare professionals caring for patients with psoriatic arthritis, this discussion offers insight into emerging research on dual IL-23 and TNF inhibition. The review highlights the rationale for combination biologic therapy and the need for further research to clarify its efficacy, safety, and potential role in patients with an inadequate response to TNF inhibitors. Visit the RhAPP Content Rheum or RhAPP ACE app for more rheumatology education, medication reviews, and journal clubs.

In this medication review, Jessica Tapia, NP, a family nurse practitioner in rheumatology at HonorHealth in Phoenix, Arizona, reviews belimumab (Benlysta) dosing for systemic lupus erythematosus (SLE) and lupus nephritis in adult and pediatric patients. This overview explores intravenous (IV) and subcutaneous administration, highlighting how dosing schedules vary by disease state, age, and body weight.This episode covers initial and maintenance dosing, weight-based pediatric regimens, and considerations for transitioning from IV infusions to subcutaneous injections. Jessica also discusses autoinjector and prefilled syringe options, age-related considerations for each formulation, and key differences between SLE and lupus nephritis dosing. Drawing on her clinical experience, she explains how patient preferences and comfort with self-injection can help guide the choice of administration method.Designed for rheumatology advanced practice providers, nurse practitioners, physician assistants, and other clinicians managing lupus and lupus nephritis, this medication review offers practical insights into Benlysta dosing, administration, and individualized treatment planning. For more rheumatology education and clinical resources, visit RhAPP’s website, the RhAPP Content Rheum, or the RhAPP ACE app.

In this FAQ video module, Amanda Mixon, PA-C, explains the difference between the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS), two validated tools used to assess disease activity in axial spondyloarthritis. She reviews how BASDAI uses six patient-reported questions to evaluate fatigue, spinal pain, peripheral joint symptoms, enthesitis-related tenderness, and morning stiffness, providing a quick and practical measure of a patient’s overall symptom burden.This episode also explores how ASDAS combines patient-reported symptoms with an objective marker of inflammation, such as C-reactive protein or erythrocyte sedimentation rate. Amanda discusses the established ASDAS disease activity categories, its ability to measure clinically important improvement, and its value in monitoring treatment response, predicting radiographic progression, and supporting clinical decision-making. She also explains why BASDAI scores may remain elevated because of factors beyond active inflammation, including structural damage, osteoarthritis, fibromyalgia, sleep disturbances, or mood disorders.Designed for rheumatology advanced practice providers, nurse practitioners, physician assistants, and clinicians caring for patients with axial spondyloarthritis or ankylosing spondylitis, this FAQ highlights why BASDAI and ASDAS should be viewed as complementary tools. BASDAI helps clinicians understand how the patient feels, while ASDAS adds objective evidence of inflammation to provide a more complete picture of disease activity. For more rheumatology education and clinical resources, visit RhAPP’s website, the RhAPP content rheum, or the RhAPP ACE app.

In this medication review, Amanda Mixon, PA-C, reviews the APEX and SOLSTICE clinical trials and their implications for guselkumab (Tremfya) in active psoriatic arthritis (PsA). This overview highlights the role of IL-23 inhibition in psoriatic arthritis management, including the APEX findings that supported a U.S. prescribing information update addressing inhibition of structural joint damage. This episode explores the APEX data on radiographic progression and the SOLSTICE findings in patients with an inadequate response or intolerance to prior tumor necrosis factor (TNF) inhibitor therapy. Amanda discusses key outcomes across joint symptoms, physical function, enthesitis, dactylitis, skin psoriasis, and minimal disease activity, along with the reported safety findings. The discussion emphasizes how these studies may inform treatment sequencing and conversations about symptom control, joint preservation, and individualized treatment goals. Designed for rheumatology advanced practice providers, nurse practitioners, physician assistants, and other clinicians managing psoriatic arthritis, this module offers practical insights into guselkumab clinical trial data, structural damage prevention, and shared decision-making when selecting biologic therapy. For more rheumatology education and clinical resources, visit RhAPP’s website, the RhAPP Content Rheum, or the RhAPP ACE 2.0 app.