Skyrizi (risankizumab-rzaa) / AbbVie, Boehringer Ingelheim - LARVOL DELTA

Anti-CD19 chimeric antigen receptor T-cell therapy for patients with non-Hodgkin's lymphoma and concurrent autoimmune disease (ASH 2025) - "methotrexate, hydroxychloroquine (HCQ),azathioprine); 9 required biologic/targeted DMARD (ex. adalimumab, etanercept, risankizumab,infliximab, rituximab).DMARDs were weaned prior to CART however 9 pts (37.5%) remained on AID tx at the time of cellcollection, including HCQ (n=4), sulfasalazine/mesalamine (n=2), and 1 each of prednisone, colestipol,sulfasalazine, and apremilast... In this single center study of pts receiving CART for NHL we found no difference in responserates nor survival outcomes in pts with or without AID and therefore propose that AID should notpreclude the use of CART. Lower severity of ICANS was seen in AID pts, though additional study withlarger cohorts is required. The majority of pts were able to taper off AID tx prior to CART, while HCQ wasable to be safely continued throughout CART collection with no apparent effect on CART efficacy."

CAR T-Cell Therapy • Clinical • Ankylosing Spondylitis • B Cell Non-Hodgkin Lymphoma • CNS Disorders • Dermatology • Dermatomyositis • Gastroenterology • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lymphoma • Myasthenia Gravis • Myositis • Non-Hodgkin’s Lymphoma • Psoriasis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

P017 A multifaceted case of pyoderma gangrenosum: insights into diagnosis and management in the presence of comorbid conditions. (PubMed, Br J Dermatol) - "She initially presented with a large ulcerative lesion that was misdiagnosed as a fungal infection and treated unsuccessfully with terbinafine...The patient's treatment journey involved multiple immunosuppressive therapies, such as prednisolone and ciclosporin, although ciclosporin was later discontinued due to kidney complications. She was also treated with mycophenolate mofetil, which was halted after it aggravated her diverticular disease, and with dapsone, which was eventually stopped due to liver-related concerns...She is currently under close, multidisciplinary monitoring and is awaiting approval for biologic therapy with risankizumab, which her gastroenterology team favours over infliximab because of liver concerns...Biologic therapies, although currently restricted, represent a promising option for refractory PG. Continuous collaboration among specialists, careful monitoring of treatment impacts on comorbidities, and further research into biologic efficacy..."

Journal • Autoimmune Hepatitis • Dermatology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Nephrology • Pain • Pyoderma Gangrenosum • Renal Disease • Septic Shock • Thrombocytopenia

O07 Serious infection risk with systemic treatments for psoriasis: a cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). (PubMed, Br J Dermatol) - "Inclusion criteria were adults who received at least one of the biologics, apremilast or conventional nonbiologics (acitretin, ciclosporin and methotrexate) for ≥ 6 months. All biologics licensed for psoriasis were analysed except for infliximab, which had higher prescription criteria...The certolizumab group had a low mean age of 37.4 years (SD 10.3), the ustekinumab group had a significantly longer median treatment duration of over 4 years (IQR 1.83-6.73), and more patients in the ixekizumab (42.6%) and certolizumab (40.6%) groups had concomitant psoriatic arthritis...IRs (95% CIs) of other tumour necrosis factor-α inhibitors were 15.7 (14.5-17.1) for adalimumab and 16.7 (13.8-20.0) for etanercept. For interleukin-17 inhibitors the IRs (95% CIs) were 18.4 (15.9-21.2) for secukinumab, 7.63 (0.92-27.6) for bimekizumab, 14.5 (7.73-24.8) for brodalumab and 18.5 (14.0-24.0) for ixekizumab. For interleukin-23 inhibitors the IRs (95% CIs) were 13.5 (9.97-17.8) for guselkumab,..."

Journal • Observational data • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A

P100 Effectiveness of risankizumab in biologic-naive and biologic-experienced patients with psoriasis: real-world data from the BADBIR registry. (PubMed, Br J Dermatol) - "Significantly more biologic-naive patients achieved complete skin clearance within 2 years compared with biologic-experienced patients (56.5% vs. 30.8%, P < 0.001). Real-world UK data confirm high levels of skin clearance and sustained response with risankizumab, consistently with clinical trial data."

Journal • Real-world evidence • Dermatology • Immunology • Psoriasis

O05 A retrospective review of cases of psoriasis requiring discontinuation of biologic therapy from 2007 to 2024 in a multisite NHS trust. (PubMed, Br J Dermatol) - "Concurrent systemic immunosuppression (methotrexate or ciclosporin) was prescribed in 21% (n = 31)...The biologics with most interventions were adalimumab or biosimilars (n = 102: Humira n = 39, Idacio n = 30, Hyrimoz n = 23, Amgevita n = 10), ustekinumab (n = 39), secukinumab (n = 35), guselkumab (n = 13) and certolizumab (n = 11)...The main blood abnormality was positive tuberculosis ELISpot assay (interferon-γ release assay) (n = 6: Humira n = 2; and Idacio, ustekinumab, etanercept and risankizumab n = 1 each). Other abnormalities included leucocytosis in sepsis (n = 2; ustekinumab, secukinumab), neutropenia (n = 1; Hyrimoz), raised alanine aminotransferase (n = 1; Humira) and raised fetal calprotectin (n = 1; Ixekizumab)...Blood abnormalities requiring treatment intervention were infrequent, most commonly positive tuberculosis testing. Our findings support reducing blood monitoring of..."

Journal • Retrospective data • Atopic Dermatitis • Dermatology • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Neutropenia • Pain • Psoriasis • Psoriatic Arthritis • Pulmonary Disease • Respiratory Diseases • Rheumatology • Septic Shock • Seronegative Spondyloarthropathies • Tuberculosis • Type 2 Diabetes Mellitus • Ulcerative Colitis • Urticaria • IFNG

A randomized phase 2 clinical trial to treat moderate-to-severe plaque psoriasis patients with high-induction dosing of risankizumab. (PubMed, Nat Commun) - P2 | "At Week 52, TRM cell numbers in lesional skin were markedly reduced, with numbers similar to non-lesional TRM numbers at Week 0. High skin clearance rates with higher-than-approved initial dosing of risankizumab with prolonged maintenance of skin clearance, despite the lack of continuous dosing, represent a potential alternative treatment strategy for patients with psoriasis."

Journal • P2 data • Dermatology • Immunology • Psoriasis

Risankizumab is effective following ustekinumab failure in Crohn's disease: A real-world study from a tertiary center. (PubMed, World J Gastrointest Pharmacol Ther) - "Switching from ustekinumab to risankizumab in active CD led to significant clinical and biochemical improvements and high remission rates, particularly in patients with SLOR. These findings support risankizumab as an effective option following ustekinumab failure in refractory CD."

Journal • Real-world evidence • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • CRP • IL12A

Successful treatment of durvalumab-induced psoriasis in an HBV-positive lung cancer patient with Risankizumab: A novel case report. (PubMed, Eur J Cancer) - No abstract available

Journal • Dermatology • Immunology • Lung Cancer • Oncology • Psoriasis • Solid Tumor

Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis (clinicaltrials.gov) - P4 | N=214 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

Efficacy and safety of IL-23p19 and IL-12/23p40 inhibitors in moderate-to-severe Crohn's disease: a systematic review and network meta-analysis. (PubMed, Ann Med) - "Interleukin (IL)-23 inhibitors-including IL-23p19 inhibitors (guselkumab, mirikizumab, risankizumab) and the IL-12/23p40 inhibitor ustekinumab-are emerging treatments for Crohn's disease (CD), but comparative data among them remain limited. This is the first NMA comparing IL-23 inhibitors using contemporary evidence. The results offer practical insights for personalized CD treatment: guselkumab may be preferred for rapid response, mirikizumab for safety, and risankizumab for balanced efficacy."

Clinical • Journal • Retrospective data • Review • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL12A • IL23A

Real-World Effectiveness of Risankizumab in Crohn's Disease: Outcome Data for an IL-23 Inhibitor from the Middle East. (PubMed, Crohns Colitis 360) - "In AT-exposed patients, prior ustekinumab exposure was associated with lower remission rates (OR 0.11, P = .021) and a higher likelihood of dose intensification (OR 5.67, P = .045). No new safety signals were identified. This first Middle Eastern real-world study confirms risankizumab is effective and safe for complex CD and supports its use across different treatment lines."

Journal • Real-world evidence • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • CRP • IL23A

Time to lift the moratorium on IL-23 inhibitors for axial psoriatic arthritis. (PubMed, Lancet Rheumatol) - "However, post-hoc analyses of clinical trials show clinical improvements in axial psoriatic arthritis following treatment with ustekinumab, guselkumab, and risankizumab...Furthermore, inadequate response to biological therapies in axial spondyloarthritis was associated with absence of MRI-determined bone marrow oedema, whereas responses to secukinumab in axial spondyloarthritis were independent of bone marrow oedema, pointing to divergent pathophysiological processes. The growing recognition of clinical, microanatomical, and immunological differences between axial spondyloarthritis and axial psoriatic arthritis suggests differential IL-23 pathway dependence. This Personal View aims to provide a deeper examination of these distinctions as a basis to propose reconsidering the current moratorium on IL-23 inhibitors-particularly in phenotypes not linked to HLA-B27-and to potentially expand therapeutic options."

Journal • Review • Ankylosing Spondylitis • Immunology • Inflammation • Inflammatory Arthritis • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • CRP • IL23A

Utilisation and real-world effectiveness of advanced therapies for inflammatory bowel disease in Middle Eastern populations: a systematic review. (PubMed, BMJ Open Gastroenterol) - "Advanced therapies for IBD appear to be effective in Middle Eastern cohorts; however, the available evidence is methodologically diverse, with substantial heterogeneity in study design, population characteristics and outcome reporting, which limits the ability to draw strong conclusions and highlights the need for further robust evaluation. Prospective, collaborative regional registries are imperative to address these gaps and inform local guidelines."

Journal • Real-world evidence • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Pediatrics • Ulcerative Colitis

Subacute Annular Pustular Psoriasis with Flexural Accentuation: Dramatic Response to Risankizumab. (PubMed, Acta Derm Venereol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

EFICACIA DE LA INDUCCIÓN EXTENDIDA INTRAVENOSA CON RISANKIZUMAB EN ENFERMEDAD DE CROHN REFRACTARIA. (PubMed, Gastroenterol Hepatol) - No abstract available

Journal • Crohn's disease • Gastroenterology • Immunology

Efficacy and Safety of Risankizumab in Psoriatic Patients With a History of Malignancy: Real-World Evidence From a Multicentre Spanish Study. (PubMed, Australas J Dermatol) - "Tolerance was favourable, and no tumour recurrence was considered treatment-related. These findings support risankizumab as an effective and safe therapeutic option for this subpopulation."

HEOR • Journal • Real-world evidence • Dermatology • Immunology • Oncology • Psoriasis

Successful dual targeted therapy with upadacitinib and risankizumab in psoriatic arthritis, uveitis and alopecia areata. (PubMed, Joint Bone Spine) - No abstract available

Journal • Alopecia • Immunology • Inflammatory Arthritis • Ocular Inflammation • Ophthalmology • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Uveitis

Efficacy and Safety of Risankizumab in Patients with Moderately to Severely Active Crohn's Disease: Interim Results from the SEQUENCE Open-Label Extension Study. (PubMed, J Crohns Colitis) - P3 | "This interim analysis of continuous open-label risankizumab therapy showed durable long-term clinical efficacy and no new safety signals in patients with moderately to severely active Crohn's disease. Future analyses will evaluate longer-term clinical and endoscopic outcomes and safety."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=213 | Not yet recruiting | Sponsor: Chong Kun Dang Pharmaceutical

New P1 trial • Dermatology • Immunology • Psoriasis

VOYAGER: Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: University Medical Center Groningen

New P1/2 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Accuracy of Budget Impact Projections in Bulgarian Health Technology Assessment: A Five-Year Validation Study (2020-2025). (PubMed, Healthcare (Basel)) - "Large overshoots were observed for Avelumab, Risankizumab, and Guselkumab; Cobimetinib and Abemaciclib remained below forecast. Health Technology Assessment Budget Impact Analyses captured broad cost scaling but systematically missed product-specific uptake, with deviations largely volume-driven. Strengthening national registries and real-world data pipelines, and adopting dynamic, indication-responsive contracting and forecasting, could materially improve budget predictability while preserving access to innovation."

HEOR • Journal • Oncology

Efficacy of Risankizumab across distinct PsA phenotypes identified with machine learning analytics using data from biologic DMARD-Naïve patients in two phase 3 clinical trials. (PubMed, Arthritis Res Ther) - P3 | "Five distinct PsA phenotypes were identified in patients starting risankizumab. Moderate to High Disease Activity, the most frequent phenotype, showed the highest response, though risankizumab demonstrated efficacy across all phenotypes. These results are a first step toward more personalized medicine for patients with PsA."

Journal • P3 data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Biologic Breakthroughs: Comparing the Safety and Efficacy of Risankizumab and Bimekizumab in Psoriasis (ISDS 2025) - "The significantly higher rate of any adverse event with Bimekizumab use provides an important consideration for clinicians when choosing treatment for patients with psoriasis, while Risankizumab's significantly decreased risk of severe adverse events, could indicate favorable use."

Clinical • Dermatology • Immunology • Psoriasis • IL17A • IL23A

EVERLAST-A: A Phase 2a Study Design of ORKA-001, a Novel Half-Life Extended IL-23p19 Monoclonal Antibody for Plaque Psoriasis (ISDS 2025) - "ORKA-001 is a novel half-life extended monoclonal antibody targeting IL-23p19 with similar potency and epitope binding to risankizumab... EVERLAST-A is a Phase 2 proof-of-concept study evaluating efficacy and safety of ORKA-001 in adults with moderate-to-severe psoriasis. The study aims to investigate whether high induction doses of ORKA- 001 can lead to increased rates of skin clearance and prolonged durability of responses."

P2a data • Dermatology • Immunology • Psoriasis • IL23A

SKYRIZI (risankizumab) Receives Positive Reimbursement Recommendation by Canada’s Drug Agency for Ulcerative Colitis and AbbVie Concludes Letter of Intent with the pan-Canadian Pharmaceutical Alliance (GlobeNewswire) - "...supported by evidence from pivotal phase 3 clinical trials....INSPIRE, COMMAND (for UC)."

Reimbursement • Ulcerative Colitis