Official health care professional site from AbbVie Inc. Find safety and prescribing information, including BOXED WARNING, for HUMIRA (adalimumab).

Sep 26th, 2019 - BACKGROUND Biologic therapies are widely used in patients with ulcerative colitis. Head-to-head trials of these therapies in patients with inflammatory bowel disease are lacking. METHODS In a phase 3b, double-blind, double-dummy, randomized trial conducted at 245 centers in 34 countries, we compared vedolizumab with adalimumab in adults with moderately to severely active ulcerative colitis to ...

Jul 24th, 2019 - Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® i (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Please see below the full indicatio...

Jun 27th, 2019 - Dosing See Important Safety Information, including BOXED WARNING.

Jun 27th, 2019 - HUMIRA Nurse Injection Training Order Form— Rheumatology

Mar 12th, 2019 - As AbbVie’s Humira (adalimumab) tops the biggest-selling drug list again in 2018, it is hard to see where any challenger might come from to snatch the autoimmune disorder therapy’s crown ahead of its patent expiry in 2023. With the exception of Boehringer Ingelheim, AbbVie’s legal team has successfully settled with companies wanting to launch biosimilar versions of this monoclonal antibody (mAb...

Apr 9th, 2018 - AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-COMPARE clinical trial showing that after 12 weeks, upadacitinib (15 mg, once-daily) met the primary endpoints of ACR20a and clinical remissionb versus placebo.1 All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg eve...

Mar 31st, 2018 - Introduction Secukinumab and adalimumab are approved for adults with active psoriatic arthritis (PsA). In the absence of direct randomized controlled trial (RCT) data, matching-adjusted indirect comparison can estimate the comparative effectiveness in anti-tumor necrosis factor (TNF)-naïve populations. Methods Individual patient data from the FUTURE 2 RCT (secukinumab vs. placebo; N = 299) wer...

Jul 31st, 2017 - The Phase III FUTURE I and II trials demonstrated the clinical efficacy of secukinumab in active psoriatic arthritis (PsA). In the absence of head-to-head trials, this study compared the clinical efficacy and cost effectiveness of adalimumab 40 mg versus secukinumab 150 and 300 mg for the treatment of active PsA.

Mar 2nd, 2017 - Psoriatic arthritis (PsA) is a heterogeneous chronic inflammatory disease with a broad clinical spectrum and variable course. It can involve musculoskeletal structures as well as skin, nails, eyes, and gut. The management of PsA has changed tremendously in the last decade, thanks to an earlier diagnosis, an advancement in pharmacological therapies, and a wider application of a multidisciplinary...

Learn about the mechanism of action of HUMIRA (adalimumab), and how it’s used for treatment of certain immune-mediated diseases.

ADEPT was a 24-week, randomized, double-blind, parallel-group, placebo-controlled study of 313 patients with active PsA (≥3 swollen joints and ≥3 tender joints) who had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Patients were randomized to receive subcutaneous injections of either placebo (n=162) or 40 mg HUMIRA given every other week (n=151). Patients on methotrex...

May 10th, 2017 - Adalimumab is indicated for the treatment of moderate to severe psoriasis in adults. We assessed the efficacy and safety of adalimumab in children and adolescents with severe plaque psoriasis. This randomised, double-blind, multiperiod, phase 3 trial was done at 38 clinics in 13 countries. Patients (aged ≥4 to <18 years) with severe plaque psoriasis who had not responded to topical therapy were...

Aug 16th, 2016 - Hidradenitis suppurativa is a painful, chronic inflammatory skin disease with few options for effective treatment. In a phase 2 trial, adalimumab, an antibody against tumor necrosis factor α, showed efficacy against hidradenitis suppurativa. PIONEER I and II were similarly designed, phase 3 multicenter trials of adalimumab for hidradenitis suppurativa, with two double-blind, placebo-controlled ...

Apr 12th, 2016 - Little is known about in utero exposure to and postnatal clearance of anti-tumor necrosis factor (anti-TNF) agents in neonates. We investigated the concentrations of adalimumab and infliximab in umbilical cord blood of newborns and rates of clearance after birth, and how these correlated with drug concentrations in mothers at birth and risk of infection during the first year of life. We perform...

Sep 1st, 2015 - The risks of hospitalized infection associated with biologic agents used to treat rheumatoid arthritis (RA) are unclear. The aim of this study was to determine whether the associated risk of hospitalized infections differed between specific biologic agents used to treat RA. In a retrospective cohort study using Medicare data from 2006-2011 for all enrolled patients with RA, new episodes of trea...

Sep 28th, 2021 - The safety and effectiveness of live virus vaccines, such as the varicella-zoster vaccine, are unknown in patients with inflammatory diseases receiving immunomodulatory therapy such as tumor necrosis factor inhibitors (TNFis). To evaluate the safety and immunogenicity of the live attenuated zoster vaccine (ZVL) in patients receiving TNFis. Randomized, blinded, placebo-controlled trial. (Clinica...

Dec 5th, 2014 - Nail psoriasis can be difficult to treat and has a significant effect on quality of life. Relatively few controlled trials evaluating treatments for nail psoriasis have been published. There is an unmet need for treatment recommendations to guide therapeutic decisions. To develop treatment recommendations for nail psoriasis from the Medical Board of the National Psoriasis Foundation. A PubMed s...

Aug 19th, 2021 - Surgery is a mainstay in the management of hidradenitis suppurativa (HS). Adalimumab is the first drug approved for HS. To investigate the efficacy and safety of adalimumab in combination with wide-excision surgery followed by secondary intention healing. The Safety and Efficacy of Adalimumab for Hidradenitis Suppurativa Peri-Surgically (SHARPS) trial was a phase 4, randomized, double-blind, pl...

Jul 3rd, 2013 - Antibodies against tumor necrosis factor-α are widely used to treat patients with Crohn's disease (CD). This study compared the effectiveness of infliximab and adalimumab, the 2 most commonly used anti-tumor necrosis factor agents, in patients with CD. We conducted a retrospective cohort study by using U.S. Medicare data from 2006 through 2010. Patients with CD who were new users of infliximab ...