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Adalimumab-ryvk

(Simlandi®)

Simlandi®

Drug updated on 10/17/2024

Dosage FormInjection (subcutaneous; 40 mg/0.4 mL [single-dose autoinjector]; 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.2 mL [single-dose prefilled glass syringe])
Drug ClassTumor necrosis factor (TNF) blockers
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for rheumatoid arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA
  • Indicated for juvenile idiopathic arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older
  • Indicated for psoriatic arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
  • Indicated for ankylosing spondylitis (AS): reducing signs and symptoms in adult patients with active AS
  • Indicated for Crohns disease (CD): treatment of moderately to severely active Crohns disease in adults and pediatric patients 6 years of age and older
  • Indicated for ulcerative colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients
  • Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers
  • Indicated for plaque psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate
  • Indicated for hidradenitis suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients
  • Indicated for uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults patients.

Latest News

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Summary
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  • This summary is based on the review of 99 systematic review(s)/meta-analysis(es). [1-99]
  • Psoriasis: Adalimumab showed significantly higher effectiveness than methotrexate in achieving PASI (PASI 75) 75 (OR = 4.50), PGA (Physician Global Assessment) 0/1 response (OR = 4.86), PASI 100 (OR = 3.01), and improving DLQI (SMD (Standardized Mean Difference) = -0.60).
  • Ulcerative Colitis: Adalimumab demonstrated 75.40% mucosal healing, 70.79% clinical remission, and 83.02% clinical response, with the highest effectiveness observed at 40 mg over 52 weeks.
  • Rheumatoid Arthritis: JAK (RCTs) inhibitors (Tofacitinib, low-dose Decernotinib, high-dose Peficitinib) showed higher effectiveness in achieving ACR20 (CD)/50/70 compared to adalimumab, with Decernotinib ranking highest.
  • Crohn's Disease: Infliximab was superior in early induction of remission over other agents, except risankizumab and adalimumab, while adalimumab showed a high clinical response in bio-exposed patients, with no significant superiority over infliximab.
  • For psoriasis, there was no significant difference in adverse events or serious adverse events between adalimumab and methotrexate.
  • In ulcerative colitis, adalimumab demonstrated a comparable safety profile to other biologics.
  • In rheumatoid arthritis, tofacitinib showed higher all-cause mortality compared to adalimumab, while low-dose filgotinib ranked highest in safety.
  • For Crohn’s disease, adalimumab had a non-significant difference in serious adverse events compared to infliximab.
  • Age and Gender: In ulcerative colitis, effectiveness was evaluated across different ages and genders, with no specific differential outcomes noted. Adalimumab was effective in pediatric Crohn's disease, including both children and adolescents.
  • Bio-Exposed vs. Bio-Naive: In Crohn's disease, a notable difference in drug effectiveness was observed between bio-exposed and bio-naive patients, with adalimumab showing high clinical response in bio-exposed patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Simlandi (adalimumab-ryvk) Prescribing Information.2024Teva Pharmaceuticals, Parsippany, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparison of adalimumab with methotrexate for psoriasis: A meta-analysis of randomized controlled studies2024Medicine
Effectiveness of adalimumab in severe ulcerative colitis: A systematic review and a meta-analysis2024Health Science Reports
The efficacy and safety of different Janus kinase inhibitors as monotherapy in rheumatoid arthritis: A Bayesian network meta-analysis2024PLoS One
Network meta-analysis: Comparative onset of early effect of biologics and small molecules in moderately to severely active luminal Crohn's disease2024Alimentary Pharmacology and Therapeutics
Response to Biologic Therapy in Skin of Colour Participants With Moderate-to-Severe Psoriasis and Atopic Dermatitis: A Systematic Review2024Journal of Cutaneous Medicine and Surgery
Efficacy and Safety of Infliximab Versus Adalimumab in Adult Subjects With Moderate to Severe Ulcerative Colitis: A Systematic Review and Meta-Analysis2024Cureus
Comparative efficacy and therapeutic positioning of biologics in hidradenitis suppurativa: A systematic review with network meta-analysis of randomised trials2024Indian Journal of Dermatology
Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis2024Annals of the Rheumatic Diseases
An Overview of Adalimumab Therapy for Ankylosing Spondylitis2024Current Rheumatology Reviews
Efficacy and safety of adalimumab in pediatric patients with Crohn's disease: A systematic review and meta-analysis2024European Journal of Clinical Pharmacology
An indirect comparison of efficacy including histologic assessment and safety in biologic therapy in ulcerative colitis: Systemic review and network meta-analysis2023PLoS One
Cardiovascular safety of Janus kinase inhibitors in patients with rheumatoid arthritis: systematic review and network meta-analysis2023Frontiers in Pharmacology
Efficacy and safety evaluations of adalimumab biosimilars in the treatment of psoriasis2023Journal of Dermatological Treatment
Systematic review of studies comparing infliximab and adalimumab in autoimmune uveitis2023BMJ Open Ophthalmology
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2023The Cochrane Database of Systematic Reviews
Systematic review of clinical practice guidelines for uveitis2023BMJ Open Ophthalmology
Comparison of Effectiveness and Safety of Ustekinumab and Adalimumab As Induction or Maintenance Therapy in Patients With Moderate to Severe Crohn's Disease: A Systematic Review and Meta-Analysis2023Cureus
Comparison of infliximab with adalimumab for the treatment of non-infectious uveitis: a systematic review and meta-analysis2023JAMA Netw Open
Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis2023Pharmaceutics
Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysis2023JAMA Network Open
Cost per responder of biologic drugs used in the treatment of moderate-to-severe plaque psoriasis in France and Germany2023Current Medical Research and Opinion
Use of biologics for the management of Crohn's disease: IG-IBD technical review based on the GRADE methodology2023Digestive and Liver Disease
Cost-Effectiveness Analysis of Tofacitinib Compared with Biologics in Biologic-Naive Patients with Moderate-to-Severe Ulcerative Colitis in Japan2023Pharmacoeconomics
Efficacy and safety of TNF inhibitors in the treatment of juvenile idiopathic arthritis: a systematic literature review2023Pediatric Rheumatology Online Journal
Comparative efficacy of advanced treatments in biologic-naive or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis2023International Journal of Clinical Pharmacy
Efficacy of biological therapies and small molecules in induction and maintenance of remission in luminal Crohn's disease: systematic review and network meta-analysis2023Gut
Comparative Efficacy of Biologic Therapies for Inducing Response and Remission in Fistulizing Crohn's Disease: Systematic Review and Network Meta-Analysis of Randomized Controlled Trials2023Inflammatory Bowel Diseases
Comparative safety of infliximab and adalimumab on pregnancy outcomes of women with inflammatory bowel diseases: a systematic review & meta-analysis2022Gut
Tumor necrosis factor (TNF) inhibitors for juvenile idiopathic arthritis-associated uveitis2022The Cochrane Database of Systematic Reviews
Adalimumab for induction of remission in patients with Crohn's disease: a systematic review and meta-analysis2022European Journal of Medical Research
Real-world effectiveness of biological therapy in patients with rheumatoid arthritis: Systematic review and meta-analysis2022Frontiers in Pharmacology
Efficacy and safety of adalimumab in comparison to infliximab for Crohn's disease: A systematic review and meta-analysis2022World Journal of Clinical Cases
Efficacy of Bimekizumab and Other Biologics in Moderate to Severe Plaque Psoriasis: A Systematic Literature Review and a Network Meta-Analysis2022Dermatology and Therapy
Biologics and Small Molecule Inhibitors for Treating Hidradenitis Suppurativa: A Systematic Review and Meta-Analysis2022Biomedicines
Adalimumab Effect on Pain in Hidradenitis Suppurativa Patients: Systematic Review and Meta-Analysis2022Lancet Gastroenterol Hepatol
Biologics Can Significantly Improve Dermatology Life Quality Index (DLQI) in Psoriatic Patients: A Systematic Review2022Medicine (Baltimore)
Comparison of Adalimumab to Other Targeted Therapies in Rheumatoid Arthritis: Results from Systematic Literature Review and Meta-Analysis2022Journal of personalized medicine
Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes2022RMD Open
Incidence of and Risk Factors for Paradoxical Psoriasis or Psoriasiform Lesions in Inflammatory Bowel Disease Patients Receiving Anti-TNF Therapy: Systematic Review With Meta-Analysis2022Frontiers in Immunology
The Risk of Adverse Effects of TNF-alpha Inhibitors in Patients With Rheumatoid Arthritis: A Network Meta-Analysis2022Frontiers in Immunology
Therapies for hidradenitis suppurativa: a systematic review with a focus on Brazil2022Drugs in Context
Rheumatoid arthritis and myasthenia gravis: a case-based review of the therapeutic options2022Clinical Rheumatology
Comparative efficacy of secukinumab against adalimumab and infliximab in patients with moderate-to-severe plaque psoriasis2022Chinese Medical Journal
Prediction of Relapse After Anti-Tumor Necrosis Factor Cessation in Crohn's Disease: Individual Participant Data Meta-analysis of 1317 Patients From 14 Studies2022Clinical Gastroenterology and Hepatology
Systematic review and meta-analysis of biosimilar for the treatment of rheumatoid arthritis informing the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis2022Modern Rheumatology
Network meta-analysis comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis2022The Journal of Dermatological Treatment
Cost per responder analysis of guselkumab versus targeted therapies in the treatment of moderate to severe plaque psoriasis in Germany2022Journal of Dermatological Treatment
Biologics and small molecules in patients with scalp psoriasis: a systematic review2022The Journal of Dermatological Treatment
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year2022The Journal of Dermatological Treatment
An economic evaluation of risankizumab versus other biologic treatments of moderate to severe plaque psoriasis in Japan2022Journal of Dermatological Treatment
Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis2021The Lancet. Gastroenterology & Hepatology
Comparison of the efficacy and safety indicators of DMARDs for rheumatoid arthritis: A network meta-analysis2021Medicine
Comparison of the efficacy and safety of tocilizumab, sarilumab, and sirukumab in comparison with adalimumab as monotherapy in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials2021International Journal of Clinical Pharmacology and Therapeutics
Efficacy and safety of adalimumab in hidradenitis suppurativa: A systematic review and meta-analysis of randomized controlled trials2021BioDrugs
Efficacy and Safety of Adalimumab in Noninfectious Uveitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2021Pharmacoeconomics
Systematic Review and Network Meta-Analysis: Comparative Efficacy and Safety of Biosimilars, Biologics and JAK1 Inhibitors for Active Crohn Disease2021Frontiers in Pharmacology
Impact of Biological Agents on Imaging and Biomarkers of Cardiovascular Disease in Patients with Psoriasis: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials2021The Journal of investigative dermatology
Efficacy and Safety of Anti-TNFalpha Therapy for Uveitis Associated with Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis2021Rheumatology and Therapy
Integrating efficacy and safety of vedolizumab compared with other advanced therapies to assess net clinical benefit of ulcerative colitis treatments: a network meta-analysis2021Expert Review of Gastroenterology & Hepatology
Cost per cumulative clinical benefit of biologic therapies for patients with plaque psoriasis: a systematic review2021Journal of Managed care & Specialty Pharmacy
Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis2021RMD Open
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity2021Rheumatology and Therapy
TNF Inhibitors and Risk of Malignancy in Patients with Inflammatory Bowel Diseases: A Systematic Review2021Journal of Crohn's & Colitis
Model-Based Meta-Analysis Compares DAS28 Rheumatoid Arthritis Treatment Effects and Suggests an Expedited Trial Design for Early Clinical Development2021Clinical Pharmacology and Therapeutics
The effects of selected biologics and a small molecule on Health-Related Quality of Life in adult plaque psoriasis patients: A systematic review and meta-analysis2020PLoS One
Safety and efficacy of newer biologics DMARDs in the management of rheumatoid arthritis: A systematic review2020Osteoarthritis and Cartilage Open
Efficacy and safety of immunomodulatory drugs in patients with non-infectious intermediate and posterior uveitis, panuveitis and macular edema: A systematic literature review2020Dermatology
Effectiveness and Safety of Systemic Therapy for Psoriasis in Older Adults: A Systematic Review2020JAMA Dermatology
Short-term effectiveness of biologics in patients with moderate-to-severe plaque psoriasis: A systematic review and network meta-analysis2020Journal of Dermatological Science
Efficacy of Brodalumab for Moderate to Severe Plaque Psoriasis: A Canadian Network Meta-Analysis2020Journal of Cutaneous Medicine and Surgery
Comparing the efficacy and tolerability of biologic therapies in psoriasis: an updated network meta-analysis2020The British Journal of Dermatology
Comparison of the efficacy and safety of tofacitinib and peficitinib in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials2020International Journal of Rheumatic Diseases
The benefit-risk balance for biological agents in juvenile idiopathic arthritis: a meta-analysis of randomized clinical trials2020Rheumatology
Comparative effectiveness of improvement in pain and physical function for baricitinib versus adalimumab, tocilizumab and tofacitinib monotherapies in rheumatoid arthritis patients who are naive to treatment with biologic or conventional synthetic disease-modifying antirheumatic drugs: a matching-adjusted indirect comparison2020RMD Open
Efficacy of anti-TNFalpha drugs in patients with stricturing Crohn's disease2020Expert Review of Gastroenterology & Hepatology
Comparative efficacy and safety of 100 mg and 200 mg filgotinib administered to patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials2020International Journal of Clinical Pharmacology and Therapeutics
Long-Term Efficacy of Anti-Tumor Necrosis Factor Agents in Pediatric Luminal Crohn's Disease: A Systematic Review of Real-World Evidence Studies2020Pediatric Gastroenterology, Hepatology & Nutrition
Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis2020Annals of the Rheumatic Diseases
Efficacy of Tumour Necrosis Factor-alpha therapy in paediatric Crohn's disease patients with perianal lesions: a systematic review2020Expert Opinion on Biological Therapy
Efficacy of ustekinumab vs. advanced therapies for the treatment of moderately to severely active ulcerative colitis: a systematic review and network meta-analysis2020Current Medical Research and Opinion
Biologic Treatment in Elderly Patients With Psoriasis: A Systematic Review2020Journal of Cutaneous Medicine and Surgery
First- and Second-Line Pharmacotherapies for Patients With Moderate to Severely Active Ulcerative Colitis: An Updated Network Meta-Analysis2020Clinical Gastroenterology and Hepatology
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2020The Cochrane Database of Systematic Reviews
Comparison of cumulative clinical benefits of biologics for the treatment of psoriasis over 16 weeks: Results from a network meta-analysis2020Journal of the American Academy of Dermatology
Comparison of the efficacy and safety of tofacitinib and filgotinib in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials2020Zeitschrift fur Rheumatologie
Biologic therapy for Behcet's uveitis: a systematic review2020British Journal of Ophthalmology
Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis2020The Annals of Pharmacotherapy
Weekly adalimumab treatment decreased disease flare in hidradenitis suppurativa over 36 weeks: integrated results from the phase 3 PIONEER trials2020Journal of the European Academy of Dermatology and Venereology
Meta-Analyses of Clinical Efficacy of Risankizumab and Adalimumab in Chronic Plaque Psoriasis: Supporting Evidence of Risankizumab Superiority2020Clinical Pharmacology and Therapeutics
Comparative Risk of Serious Infections With Biologic and/or Immunosuppressive Therapy in Patients With Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis2020Clinical Gastroenterology and Hepatology
Treatment of Dactylitis and Enthesitis in Psoriatic Arthritis with Biologic Agents: A Systematic Review and Metaanalysis2020The Journal of Rheumatology
Efficacy and safety of biologic agents and tofacitinib in moderate-to-severe ulcerative colitis: A systematic overview of meta-analyses2019United European Gastroenterology Journal
The Efficacy and Evidence-Based Use of Biologics in Children and Adolescents: Using Monoclonal Antibodies and Fusion Proteins as Treatments2019Deutsches Arzteblatt International
Decision-Analytic Modeling for Time-Effectiveness of the Sequence of Induction Treatments for Moderate to Severe Plaque Psoriasis2019JAMA Dermatology
Different Original and Biosimilar TNF Inhibitors Similarly Reduce Joint Destruction in Rheumatoid Arthritis-A Network Meta-Analysis of 36 Randomized Controlled Trials2019International Journal of Molecular Sciences
Treatment of plaque psoriasis with IL-23p19 blockers: A systematic review and meta-analysis2019International Immunopharmacology
Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: A systematic review and network meta-analysis2019Seminars in Arthritis and Rheumatism
A cost per responder analysis of secukinumab vs adalimumab for the treatment of ankylosing spondylitis from the Korean perspective2019International Journal of Rheumatic Diseases
Immunogenicity of biologic agents in juvenile idiopathic arthritis: a systematic review and meta-analysis2019Rheumatology

Clinical Practice Guidelines

Document TitleYearSource
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update2023Annals of the Rheumatic Diseases
Drug treatment algorithm and recommendations from the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis—secondary publication2023Modern Rheumatology