The goal of this N-of-1 study is to learn about treatment for individual patients who have rheumatoid arthritis (RA,) for which many treatments are available. The treatments are different in how they work, the way they are given, side- effects, and cost. While treatment guidelines are available, finding the best treatment order of treatments is often based on physician choice. The main question this study aims to answer are:
* What are the effects of different treatments on RA symptoms and condition for each individual patient
* What is the effectiveness of different treatments across all patients enrolled in the N-of-1 study
Participants will be enrolled and randomized to a sequence of three U.S. Food and Drug Administration (FDA) approved RA medications: 1. etanercept, 2. adalimumab, 3. upadacitinib 4. tocilizumab. Participants will be asked to complete questionnaires about their condition and quality of life weekly (either in clinic or remotely) and report their level of pain daily (remotely).

Start Date15 May 2025

Sponsor / Collaborator

Tufts Medical Center, Inc.

NCT06928272

/ Not yet recruitingPhase 3IIT

LC-REVITALIZE - A Long Covid Repurposed Drug Study

The Long-Covid (LC)-Revitalize clinical study is testing repurposed drug treatments for Long Covid, involving adult participants from Brazil, Canada, Italy, Uganda, Zambia, and the United States. To qualify, participants must have had Covid-19 and experienced Long Covid symptoms for at least three months. The main goal of the study is to determine whether the drug treatments can improve symptoms in five key areas: 1) fatigue, 2) breathing, 3) memory, thinking, and communication, 4) muscle and joint pain, and 5) circulation. A secondary goal is to assess changes in the body, such as reducing inflammation, as well as to confirm the safety and tolerability of the treatments. In the first phase, 348 participants will take either one of two existing medications (upadacitinib or pirfenidone) or a placebo (a pill with no active ingredient) for three months. Although these medications are not yet approved for Long Covid, they are authorized for use in treating other health conditions. This study is adaptive, meaning it may adjust based on early results. In the second phase, the study could continue testing the most effective drug(s) against a placebo with new participants, explore combinations of drugs to see if they improve results, or discontinue the drugs if they prove ineffective or unsafe and test alternative treatments.

Start Date01 May 2025

Sponsor / Collaborator

University of Western Ontario

NCT06660693

/ Not yet recruitingPhase 3IIT

Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis: an Open-label Randomized Controlled Trial (RESCUE-UC).

This study aims to examine patients with acute severe UC who are refractory to intravenous corticosteroids and determine whether a strategy of using upadacitinib first followed by infliximab in upadacitinib non-responders is non-inferior to conventional management with infliximab only.

Start Date01 May 2025

Sponsor / Collaborator

McMaster University

[+1]

100 Clinical Results associated with Upadacitinib hemihydrate

100 Translational Medicine associated with Upadacitinib hemihydrate

100 Patents (Medical) associated with Upadacitinib hemihydrate

1,276

Literatures (Medical) associated with Upadacitinib hemihydrate

31 Dec 2025·ANNALS OF MEDICINE

Cardiovascular safety of Janus kinase inhibitors in inflammatory bowel disease: a systematic review and network meta-analysis

Review

Author: Wang, Bangmao ; Yang, Huibin ; Zhang, Qingyu ; Zhao, Yuxuan ; An, Ting ; Shi, Xiaojing

BACKGROUND AND OBJECTIVE:

Janus kinase (JAK) inhibitors (JAKinibs) are effective for inflammatory bowel disease (IBD), but their cardiovascular safety is inconclusive. We aim to assess the cardiovascular risks associated with JAKinibs in IBD patients.

PATIENTS AND METHODS:

Systematic searches of seven databases and ClinicalTrials.gov from inception to February 2024 were conducted. Outcomes included major adverse cardiovascular events (MACE), venous thromboembolism events (VTE) and cardiovascular events (CVE), which were separately evaluated based on whether or not the dose was considered. P-score was applied to rank interventions.

RESULTS:

A total of 26 trials involving 10,537 IBD patients were included, and results showed no significantly increased risk of MACE, VTE and CVE was associated with JAKinibs. However, when the dose was considered, Tofacitinib 5 mg BID (versus placebo) showed a trend towards an increased risk of MACE [odds ratio (OR)=1.05, 95% confidence interval (CI): 0.23-4.82], as well as Upadacitinib 30 mg QD (versus placebo) showed a trend towards increased risks of VTE (OR=1.36, 95% CI: 0.23-8.03) and CVE (OR=1.08, 95% CI: 0.24-4.85), and ranked higher than placebo for the risk of VTE [P-score=0.766 (versus 0.722)]. Notably, Deucravacitinib ranked lowest for all cardiovascular risks, and significantly decreased the risks of VTE (OR=0.03, 95% CI: 0.00-0.87) and CVE (OR=0.03, 95% CI: 0.00-0.87) compared with placebo.

CONCLUSIONS:

Although a trend of increased cardiovascular risks was found considering dose, no significantly increased cardiovascular risk was associated with JAKinibs in IBD patients, and Deucravacitinib significantly decreased the risks of VTE and CVE.

01 Jun 2025·PHARMACOLOGICAL RESEARCH

Properties of FDA-approved small molecule protein kinase inhibitors: A 2025 update

Review

Author: Roskoski, Robert

Because of the deregulation of protein kinase action in many inflammatory diseases and cancer, the protein kinase family has become one of the most significant drug targets in the 21st century. There are 85 FDA-approved protein kinase antagonists that target about two dozen different enzymes and four of these drugs were approved in 2024 and a fifth was approved in 2025. Of these drugs, five target dual specificity protein kinases (MEK1/2), fourteen inhibit protein-serine/threonine protein kinases, twenty-one block nonreceptor protein-tyrosine kinases, and 45 target receptor protein-tyrosine kinases. The data indicate that 75 of these drugs are prescribed for the treatment of neoplasms. Seven drugs (abrocitinib, baricitinib, deucravacitinib, deuruxolitinib, ritlecitinib, tofacitinib, upadacitinib) are prescribed for the management of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis). Of the 85 FDA-approved agents, about two dozen are used in the treatment of multiple diseases. The following four drugs received FDA approval in 2024 - deuruxolitinib (alopecia areata), ensartinib and lazertinib (non-small cell lung cancer), and tovorafenib (pediatric glioma) while mirdametinib was approved in 2025 for the treatment of type I neurofibromatosis (von Recklinghausen disease). Apart from netarsudil, temsirolimus, and trilaciclib, the approved protein kinase blockers are orally bioavailable. This article summarizes the physicochemical properties of all 85 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 39 of the 85 FDA-approved drugs have a least one Lipinski rule of 5 violation.

01 May 2025·The journal of allergy and clinical immunology. Global

Subcutaneous immunotherapy in a patient taking ofatumumab for multiple sclerosis and upadacitinib for atopic dermatitis

Article

Author: Sia, Twan ; Bacchus, Leeon ; Leung, John ; Liu, Stanley

Allergen-specific immunotherapy has not been well-studied in the setting of increasingly common immune system-targeting medications. Subcutaneous immunotherapy may not be contraindicated in patients taking anti-CD20 mAbs antibodies and/or Janus kinase inhibitors.

394

News (Medical) associated with Upadacitinib hemihydrate

25 Apr 2025

·www.prnewswire.com

AbbVie Reports First-Quarter 2025 Financial Results

Reports First-Quarter Diluted EPS of $0.72 on a GAAP Basis, a Decrease of 6.5 Percent; Adjusted Diluted EPS of $2.46, an Increase of 6.5 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense Delivers First-Quarter Net Revenues of $13.343 Billion, an Increase of 8.4 Percent on a Reported Basis or 9.8 Percent on an Operational Basis First-Quarter Global Net Revenues from the Immunology Portfolio Were $6.264 Billion, an Increase of 16.6 Percent on a Reported Basis, or 18.1 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $3.425 Billion; Global Rinvoq Net Revenues Were $1.718 Billion; Global Humira Net Revenues Were $1.121 Billion First-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.282 Billion, an Increase of 16.1 Percent on a Reported Basis, or 17.0 Percent on an Operational Basis; Global Vraylar Net Revenues Were $765 Million; Global Botox Therapeutic Net Revenues Were $866 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $433 Million First-Quarter Global Net Revenues from the Oncology Portfolio Were $1.633 Billion, an Increase of 5.8 Percent on a Reported Basis, or 7.5 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $738 Million; Global Venclexta Net Revenues Were $665 Million; Global Elahere Net Revenues Were $179 Million First-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.102 Billion, a Decrease of 11.7 Percent on a Reported Basis, or 10.2 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $556 Million; Global Juvederm Net Revenues Were $231 Million Raises 2025 Adjusted Diluted EPS Guidance Range from $11.99 - $12.19 to $12.09 - $12.29, which Includes an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the First Quarter 2025 NORTH CHICAGO, Ill., April 25, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2025. "AbbVie's first-quarter results were well ahead of our expectations and reflect an excellent start to the year," said Robert A. Michael, chief executive officer, AbbVie. "The fundamentals of our business are strong and we continue to bolster our outlook with pipeline advancements and strategic investments. Based on the progress we are making, AbbVie is well positioned for the long term." First -Quarter Results Worldwide net revenues were $13.343 billion, an increase of 8.4 percent on a reported basis, or 9.8 percent on an operational basis. Global net revenues from the immunology portfolio were $6.264 billion, an increase of 16.6 percent on a reported basis, or 18.1 percent on an operational basis. Global Skyrizi net revenues were $3.425 billion, an increase of 70.5 percent on a reported basis, or 72.0 percent on an operational basis. Global Rinvoq net revenues were $1.718 billion, an increase of 57.2 percent on a reported basis, or 59.7 percent on an operational basis. Global Humira net revenues were $1.121 billion, a decrease of 50.6 percent on a reported basis, or 49.5 percent on an operational basis. Global net revenues from the neuroscience portfolio were $2.282 billion, an increase of 16.1 percent on a reported basis, or 17.0 percent on an operational basis. Global Vraylar net revenues were $765 million, an increase of 10.3 percent. Global Botox Therapeutic net revenues were $866 million, an increase of 15.8 percent on a reported basis, or 17.0 percent on an operational basis. Global Ubrelvy net revenues were $240 million, an increase of 17.8 percent on a reported basis, or 18.0 percent on an operational basis. Global Qulipta net revenues were $193 million, an increase of 47.6 percent on a reported basis, or 48.3 percent on an operational basis. Global net revenues from the oncology portfolio were $1.633 billion, an increase of 5.8 percent on a reported basis, or 7.5 percent on an operational basis. Global Imbruvica net revenues were $738 million, a decrease of 11.9 percent. Global Venclexta net revenues were $665 million, an increase of 8.3 percent on a reported basis, or 12.3 percent on an operational basis. Global Elahere net revenues were $179 million. Global net revenues from the aesthetics portfolio were $1.102 billion, a decrease of 11.7 percent on a reported basis, or 10.2 percent on an operational basis. Global Botox Cosmetic net revenues were $556 million, a decrease of 12.3 percent on a reported basis, or 10.7 percent on an operational basis. Global Juvederm net revenues were $231 million, a decrease of 22.2 percent on a reported basis, or 20.0 percent on an operational basis. On a GAAP basis, gross margin in the first quarter was 70.0 percent. The adjusted gross margin was 84.1 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 24.7 percent of net revenues. The adjusted SG&A expense was 24.6 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 15.5 percent of net revenues. The adjusted R&D expense was 15.4 percent of net revenues. Acquired IPR&D and milestones expense was 1.9 percent of net revenues. On a GAAP basis, operating margin in the first quarter was 28.0 percent. The adjusted operating margin was 42.3 percent. Net interest expense was $627 million. On a GAAP basis, the tax rate in the quarter was 22.4 percent. The adjusted tax rate was 14.2 percent. Diluted EPS in the first quarter was $0.72 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.46. These results include an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense. Recent Events AbbVie announced that its board of directors unanimously elected chief executive officer (CEO) Robert A. Michael to assume the additional position of chairman of the board of directors, effective July 1, 2025. He will succeed Richard A. Gonzalez, who formerly served as AbbVie's CEO and has been chairman since the Company's formation in 2013. AbbVie announced that the European Commission (EC) granted marketing authorization to Rinvoq (upadacitinib) for the treatment of giant cell arteritis (GCA) in adult patients. The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that Rinvoq achieved the primary endpoint of sustained remission and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete remission. This authorization marks the eighth approved indication for Rinvoq in the European Union (EU). At the Society of Gynecologic Oncology (SGO) Annual Meeting, AbbVie announced final data analysis from the Phase 3 MIRASOL trial evaluating the efficacy and safety of Elahere (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy. At 30.5 months median follow-up, treatment with Elahere continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator's choice (IC) chemotherapy. AbbVie and Xilio Therapeutics, a clinical-stage biotechnology company, announced a collaboration and option-to-license agreement that will combine AbbVie's oncology expertise with Xilio's proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers, for people living with cancer. AbbVie announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of trenibotulinumtoxinE (BoNT/E) for the treatment of moderate to severe glabellar lines. TrenibotulinumtoxinE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration and short duration of effect of 2-3 weeks. If approved, trenibotulinumtoxinE will be the first neurotoxin of its kind available to patients. Allergan Aesthetics announced that the Allergan Medical Institute (AMI) will open three new state-of-the-art training centers in the U.S., expanding access to high-quality, tailored training for licensed aesthetics providers. The first training center is scheduled to open in Irvine, CA, with additional locations to follow in Atlanta, GA and Austin, TX. AbbVie and Gubra announced a license agreement to develop GUB014295 (ABBV-295), a potential best-in-class, long-acting amylin analog for the treatment of obesity. This partnership marks AbbVie's entrance into the obesity field and under the terms of the agreement, AbbVie will lead development and commercialization of GUB014295 globally. Prior to the close of the agreement, Gubra announced positive interim results from Part A of a Phase 1 multiple ascending dose (MAD) study, which showed that GUB014295 was well tolerated with body weight loss that was sustained in a manner consistent with data from a previously announced single ascending dose (SAD) study. AbbVie announced that the FDA approved Emblaveo (aztreonam and avibactam), as the first monobactam/β-lactamase inhibitor combination antibiotic therapy to treat complicated intra-abdominal infections, including those caused by Gram-negative bacteria. The approval of Emblaveo was supported by prior findings regarding the efficacy and safety of aztreonam for the treatment of complicated intra-abdominal infections as well as clinical trial results from the Phase 3 REVISIT study, which evaluated the efficacy, safety, and tolerability of Emblaveo for the treatment of serious infections due to Gram-negative bacteria. Full-Year 2025 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.99 - $12.19 to $12.09 - $12.29, which includes an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense incurred year-to-date through the first quarter 2025. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2025, as both cannot be reliably forecasted. This guidance does not reflect the acquired IPR&D and milestones impact related to AbbVie and Gubra's licensing agreement to develop GUB014295, as that transaction closed after the first quarter of 2025. Additionally, this guidance is based on the existing trade environment and does not reflect any trade policy shifts, including pharmaceutical sector tariffs, that could impact AbbVie's business. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, neuroscience, oncology, and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our first-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3License out/inPhase 1Financial Statement

25 Apr 2025

·endpts.com

AbbVie's immunology franchise remains a powerhouse, as Skyrizi, Rinvoq combine for $5B

One quarter after AbbVie raised future sales estimates due to the successes of its immunology portfolio, the company again saw higher-than-expected revenues to start 2025. AbbVie’s overall revenues for the first quarter totaled $13.3 billion, coming in about $550 million ahead of its estimates and at an 8.4% increase over the same period last year. Immunology drugs contributed to almost half of that, totaling about $6.3 billion for the quarter. The company also raised its earnings per share forecast for 2025, up to $12.09 to $12.29 from a previous range of $11.99 to $12.19. The megablockbuster drugs Skyrizi and Rinvoq also combined for more than $5 billion in sales, with about $3.4 billion for Skyrizi and $1.7 billion for Rinvoq. The drugs’ revenues grew by 70.5% and 57.2% over the first quarter of 2024, respectively, continuing their tandem ascent to replace the former cash cow Humira. Humira sales fell more than 50% from last year’s first quarter, tallying about $1.1 billion in sales through the first three months this year. Friday’s earnings come as AbbVie has been busy on the dealmaking front in recent months, getting into the obesity race in March with a $350 million upfront deal for Gubra’s long-acting amylin analog. AbbVie also partnered with Neomorph in January for the hot molecular glue field as well as with Xilio in February in the T cell engager space. The uptick in deals may help prove a counterweight to the nearly $9 billion acquisition of Cerevel, whose centerpiece drug — a schizophrenia program called emraclidine with a similar mechanism to the recently-approved Cobenfy — failed two mid-stage trials last November. AbbVie took a $3.5 billion write-down on the acquisition and is still deliberating internally on how to best advance emraclidine in other settings.

AcquisitionDrug ApprovalBiosimilarIPO

25 Apr 2025

·www.biospace.com

AbbVie Lambasts Trump’s Drug Pricing Proposal, Deflects Tariff Concerns

iStock, OlekStock While AbbVie handily beat expectations this quarter, the company faces declining Humira sales and a challenged aesthetics business, plus the same macro headwinds blowing against the entire industry. AbbVie’s first quarter earnings beat analyst consensus, a bright spot in an industry that has otherwise been battered by macro tensions. The company is, as Guggenheim put it, “one of the nicest houses in a challenged neighborhood.” CEO Robert Michael agreed. “AbbVie is off to an excellent start to the year,” he said on the first quarter earnings call on Friday morning. Michael dismissed potential tariff impacts off the top of the call, saying that the impact on AbbVie should be “in line with peers.” AbbVie has not considered potential yet-to-be-announced tariffs in its guidance, but Michael believes the company’s manufacturing presence is adequate in the U.S. to shield from any major impacts. The company already has U.S. facilities for API, biologics, toxins and small molecules, and plans further investment of $10 billion into stateside manufacturing over the next decade to support volume growth, particularly as it expands into obesity. Chief Financial Officer Scott Reents noted that, “while it’s difficult to quantify in the absence of actual policy details,” the company expects “any unfavorability” to only affect some of 2025, as the Trump administration’s trade review will take time. “We are actively preparing for a number of potential scenarios and would expect to put into place mitigation strategies as we have more information relevant to these dynamics,” Reents said. He also echoed comments from Johnson & Johnson CEO Joaquin Duato, who last week encouraged the Trump administration to consider tax policy changes to promote a shift to U.S. manufacturing. Still, analysts wanted more details. Responding to questions later in the call, Michael said AbbVie’s robust U.S. manufacturing network allowed it to avoid drug shortages during the COVID-19 pandemic. He noted that Skyrizi is made in the U.S. for the domestic market. But AbbVie could do a few things, depending on how the tariffs fall, Michael continued. He said the company “could take management actions” or find alternate API sources. AbbVie likely will not look to raise prices of its drugs to absorb the tariff impacts, he added. “We could also look at cost efficiencies and productivity initiatives as a source of mitigation, which we always do,” the CEO said. “I think what’s more challenging is trying to pass the tariff impacts to our customers, especially with penalties in the government channel and with existing contracts in the commercial setting. So I don’t see that as a viable source for mitigation.” Michael also addressed drug pricing, responding to reports of President Donald Trump attempting to bring forward an international pricing initiative . “We hope the administration contemplates the harm that international reference pricing could have on U.S. healthcare, the U.S. healthcare industry and future innovation,” Michael said. “I think anything like price controls, cost increases or higher taxes just leave less investment available across the industry to advance new, innovative medicines.” But Michael was pleased to see Trump’s executive order addressing the “ pill penalty ” from the Inflation Reduction Act, which provided longer protection from price negotiation for biologics than small molecule drugs. Immunology Portfolio Stars AbbVie reported sales of $13.34 billion for the first quarter, compared to analyst expectations of $12.99 billion. The Illinois pharma took home $12.31 billion for the same period a year earlier. Earnings per share also rose above expectations at $2.46, compared to the estimate of $2.44. AbbVie raised guidance for the year to a range of $12.09 to $12.29, compared to $11.99 to $12.19 previously. Behind the successful quarter are immunology heavyweights Skyrizi and Rinvoq, which AbbVie has raised up to replace mega-blockbuster Humira. Skyrizi clocked $3.43 billion worldwide and Rinvoq $1.72 billion for the quarter, increases of 70% and 57%, respectively. Meanwhile, Humira continued its downward trend due to biosimilar competition , with sales of just $1.12 billion, a 50% decline. This compared to $8.99 billion for the full year of 2024 when the biosimilars market was still sorting itself out. The drug peaked in 2022 at $21.24 billion. Overall, AbbVie’s immunology portfolio rose 16% for the quarter with sales totaling $6.26 billion. Besides the Humira decline, the company’s aesthetics business was also challenged, with Botox and Juvederm underperforming due to “broader macroeconomic challenges” in the market, Guggenheim said. Chief Commercial Officer Jeff Stewart said the aesthetics decline was expected, but he’s bullish on the long-term.

Financial Statement

100 Deals associated with Upadacitinib hemihydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D10994 D11048	Upadacitinib hemihydrate	L04AA44	DB15091

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Giant Cell Arteritis	European Union	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Giant Cell Arteritis	Iceland	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Giant Cell Arteritis	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Giant Cell Arteritis	Norway	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Polyarticular Juvenile Idiopathic Arthritis	United States	AbbVie, Inc.	26 Apr 2024
Crohn's disease, active moderate	European Union	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active moderate	Iceland	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active moderate	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active moderate	Norway	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	European Union	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	Iceland	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	Norway	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn Disease	Canada	AbbVie AS	16 Jan 2020
Ankylosing Spondylitis	European Union	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Ankylosing Spondylitis	Iceland	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Ankylosing Spondylitis	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Ankylosing Spondylitis	Norway	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Arthritis, Psoriatic	European Union	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Arthritis, Psoriatic	Iceland	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dyssomnias	Phase 3	-	AbbVie, Inc.	23 May 2024
Nonsegmental vitiligo	Phase 3	United States	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	China	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Japan	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Argentina	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Belgium	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Bulgaria	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Canada	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Chile	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	France	AbbVie, Inc.	19 Dec 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03725202 (SELECT-GCA, Pubmed \| N Engl J Med)	Phase 3	Giant Cell Arteritis	-	Upadacitinib 15 mg	ucurywqenj(rojyqyuhke) = iegykjanpg xlteggnbve (lelniqllaj, 39.6 - 53.2)	Positive	02 Apr 2025
				Placebo	ucurywqenj(rojyqyuhke) = hsfvhfiggn xlteggnbve (lelniqllaj, 20.6 - 37.5)
NCT03725202 (SELECT-GCA, CTgov)	Phase 3	Giant Cell Arteritis	438	Corticosteroid (CS) (Placebo + 52-week CS Taper)	escixinwac = kjjfcwqpap wsntgytqkm (sipebqotom, akxhrqdkid - jiycvuftyu) View more	-	25 Mar 2025
				Corticosteroid (CS)+Upadacitinib (7.5 mg Upadacitinib + 26-week CS Taper)	escixinwac = ljoiyfazvf wsntgytqkm (sipebqotom, dzrirkmwvp - vglljoiuyw) View more
NCT05601882 (Level Up, CTgov)	Phase 3	Dermatitis, Atopic	920	Dupilumab (Dupilumab (Period 1))	xkkgmhfnpk = nidqvzcmvu pkigeldcle (jyjfnqikfb, kzfbodjjqf - kkrfwsfhja) View more	-	14 Feb 2025
				Upadacitinib (Upadacitinib (Period 1))	xkkgmhfnpk = gacvxfphoq pkigeldcle (jyjfnqikfb, apzhmaghmj - lobehpnsoc) View more
NCT04169373 (SELECT-AXIS 2, Pubmed \| Arthritis Res Ther)	Phase 3	Non-radiographic axial spondyloarthritis high-sensitivity C-reactive protein	313	Upadacitinib 15 mg QD	jdsepdemud(dlokzydkjy) = qbtuhkmero qypnpwfabg (oaemkwtvxf ) View more	Positive	04 Feb 2025
NCT04451772 (CTgov)	Phase 2	Systemic Lupus Erythematosus	185	Elsubrutinib+Upadacitinib (ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) -> ABBV-599 High Dose)	aminuunxbc = wzyeqcgwqm xqvaacakfb (slqnryyhpr, nminvdoztk - jfhgocrsty) View more	-	14 Jan 2025
				Placebo for Elsubrutinib+Upadacitinib (Elsubrutinib Placebo/Upadacitinib 30 mg -> Elsubrutinib Placebo/Upadacitinib 30 mg)	aminuunxbc = hhscwjamql xqvaacakfb (slqnryyhpr, ymztuxgsyc - rxlcsagjqb) View more
NCT04195698 (CTgov)	Phase 3	Dermatitis, Atopic	475	DUPI+UPA (DUPI 300mg to UPA 30mg)	kmmgplqwtw = ruuuvrzjif rzwunwyjri (ebadaaydjx, iygbitfufp - twvfimdukg) View more	-	09 Jan 2025
				UPA (UPA 30mg to UPA 30mg)	kmmgplqwtw = tuptovynvl rzwunwyjri (ebadaaydjx, xqkfiecrse - xottasmrbk) View more
NCT04169373 (SELECT-AXIS 2, Pubmed \| Arthritis Res Ther)	Phase 3	Ankylosing Spondylitis tumor necrosis factor \| interleukin-17 inhibitor	420	Continuous upadacitinib	bmnpfzygge(rhhtfivmck) = lzrdjhtdfv lgwatwggow (bcpqcldcbq )	Positive	12 Nov 2024
				Placebo to upadacitinib	bmnpfzygge(rhhtfivmck) = weiqpmabof lgwatwggow (bcpqcldcbq )
NCT03345849 \| NCT03345836 \| NCT03345823 (U-ENDURE \| U-EXCEL \| U-EXCEED, Pubmed \| J Crohns Colitis)	Phase 3	Crohn's disease, active severe Maintenance	-	Upadacitinib 45 mg	qlnwmddjqr(vmtguzjsta) = ioalngephz frdlscznww (yqcjnumgji ) View more	Positive	04 Nov 2024
				Placebo	qlnwmddjqr(vmtguzjsta) = sqxbsvqkph frdlscznww (yqcjnumgji ) View more
NCT03104374 \| NCT03104400 (SELECT-PsA 1 and 2, Pubmed \| Rheumatology (Oxford))	Phase 3	Arthritis, Psoriatic	-	Upadacitinib 15 mg once daily	lntolupqxw(grnftitzkt) = zqnhuhijbh ldnxqteace (aqcfxuzbfr )	Positive	01 Nov 2024
				Placebo	lntolupqxw(grnftitzkt) = gqyupgtpgg ldnxqteace (aqcfxuzbfr )
NCT03568318 \| NCT03569293 \| NCT03607422 (Measure Up 2, Pubmed \| JAMA Dermatol) Manual	Phase 3	Dermatitis, Atopic	542	Upadacitinib 15 mgUpadacitinib 15 mg (AD Up)	siktctzuyk(uxlrqlezre) = fwwnldyrsl lhryaqaptn (swopwerwur )	Positive	23 Oct 2024
				Upadacitinib 15 mgUpadacitinib 15 mg (Measure Up 1)	siktctzuyk(uxlrqlezre) = wvpzeahzau lhryaqaptn (swopwerwur )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis