CLINICAL TRIALS PROFILE FOR RINVOQ

All Clinical Trials for RINVOQ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02706951 ↗	A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	Active, not recruiting	AbbVie	Phase 3	2016-03-23	The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
NCT02706847 ↗	A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs	Active, not recruiting	AbbVie	Phase 3	2016-03-15	The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of 30 mg once daily (QD) and 15 mg QD upadacitinib versus placebo for the treatment of signs and symptoms of participants with moderately to severely active RA who were on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.
NCT02706873 ↗	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate	Active, not recruiting	AbbVie	Phase 3	2016-02-23	The objectives of Period 1 were the following: - To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA; - To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA. The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.
NCT02675426 ↗	A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone	Active, not recruiting	AbbVie	Phase 3	2015-12-17	The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.
NCT02049138 ↗	An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Rheumatoid Arthritis Subjects	Completed	AbbVie	Phase 2	2014-01-24	This is a Phase 2, multicenter, open-label extension study in RA subjects. The sub-study is to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background MTX on immunological responses to Prevnar 13® in RA patients.

Clinical Trial Conditions for RINVOQ

Condition Name

Condition Name for RINVOQ
Intervention	Trials
Rheumatoid Arthritis	8
Atopic Dermatitis	8
Ulcerative Colitis (UC)	3
Crohn's Disease	3

Condition MeSH

Condition MeSH for RINVOQ
Intervention	Trials
Arthritis	10
Eczema	9
Dermatitis, Atopic	9
Dermatitis	9

Clinical Trial Locations for RINVOQ

Trials by Country

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−

Trials by Country for RINVOQ
Location	Trials
United States	731
Japan	330
China	138
Canada	116
Poland	107

Trials by US State

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−

Trials by US State for RINVOQ
Location	Trials
Ohio	31
Texas	30
Florida	30
California	30
Michigan	27

Clinical Trial Progress for RINVOQ

Clinical Trial Phase

Clinical Trial Phase for RINVOQ
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	28
Phase 2	6

Clinical Trial Status

Clinical Trial Status for RINVOQ
Clinical Trial Phase	Trials
Active, not recruiting	15
Not yet recruiting	10
Recruiting	5

Clinical Trial Sponsors for RINVOQ

Sponsor Name

Sponsor Name for RINVOQ
Sponsor	Trials
AbbVie	37
Novartis	1
Pfizer	1

Sponsor Type

Sponsor Type for RINVOQ
Sponsor	Trials
Industry	41
Other	8

RINVOQ (Upadacitinib): Clinical Trials, Market Analysis, and Projections

Introduction to RINVOQ

RINVOQ, also known as upadacitinib, is a Janus kinase (JAK) inhibitor developed by AbbVie. It has been approved for the treatment of various inflammatory conditions, including rheumatoid arthritis, atopic dermatitis, and ulcerative colitis. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Ulcerative Colitis Trials

In the U-ACHIEVE Maintenance Study, RINVOQ demonstrated significant efficacy in treating ulcerative colitis. This 52-week, double-blind, placebo-controlled Phase 3 study involved 746 patients who had achieved clinical response during an 8-week induction period with RINVOQ 45 mg once daily. Patients were then randomized to receive RINVOQ 15 mg, 30 mg, or placebo once daily. The primary endpoint was clinical remission per modified Mayo Score at Week 52. The results showed that patients on RINVOQ had higher rates of clinical remission and endoscopic remission compared to those on placebo[1].

Atopic Dermatitis Trials

The Measure Up 1 and Measure Up 2 studies are Phase 3 trials that evaluated the safety and efficacy of RINVOQ in patients with moderate to severe atopic dermatitis. Patients were randomized to receive RINVOQ 15 mg, RINVOQ 30 mg, or placebo. The co-primary endpoints were the percentage of patients achieving EASI 75 and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 after 16 weeks of treatment. The results indicated that RINVOQ was effective in achieving these endpoints, demonstrating its efficacy in treating atopic dermatitis[4].

Other Indications

RINVOQ is also being studied in various other conditions, including alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo, as part of its ongoing Phase 3 clinical trials[4].

Efficacy and Safety

Disease Remission and Healing

Clinical trials have shown that RINVOQ is more effective than placebo in inducing and maintaining disease remission in patients with ulcerative colitis and other conditions. For example, in ulcerative colitis, RINVOQ led to higher rates of clinical remission and endoscopic healing compared to placebo[1][3].

Safety Considerations

While RINVOQ has demonstrated strong efficacy, it also comes with important safety considerations. The drug carries a boxed warning for serious infections, mortality, malignancies, major adverse cardiovascular events, and thrombosis. These risks highlight the need for careful patient selection and monitoring[1].

Market Analysis

Current Market Performance

RINVOQ has been a significant contributor to AbbVie's revenue growth, particularly as the company navigates the decline in sales of its blockbuster drug Humira due to biosimilar competition. In the first quarter of 2024, RINVOQ generated $1.09 billion in global sales, a 59% increase from the same period in 2023[5].

Sales Projections

AbbVie expects RINVOQ and another immunology drug, Skyrizi, to collectively achieve $16 billion in sales in 2024. By 2027, this figure is projected to exceed $27 billion, with RINVOQ alone expected to reach over $10 billion in sales across its indications in rheumatology, inflammatory bowel disease (IBD), and atopic dermatitis. Additional new disease areas for RINVOQ, anticipated to launch in the second half of the decade, are expected to contribute several billion dollars to peak sales[2].

Competitive Position

Market Share and Growth Potential

RINVOQ and Skyrizi have a strong competitive position, with high capture rates and significant headroom for further patient adoption. According to AbbVie's chief commercial officer, Jeffrey Stewart, the company is in the low end of the range in terms of total prescription share, indicating substantial growth potential[2].

Health Economic Considerations

Cost and Value Assessment

The Canadian Agency for Drugs and Technologies in Health (CADTH) has assessed RINVOQ's health economic value. While RINVOQ meets some important patient needs by providing an additional treatment option for disease remission, CADTH determined that it does not represent good value to the healthcare system at the public list price, compared to other biologic or targeted synthetic drugs[3].

Future Outlook

Expansion into New Indications

RINVOQ is being studied in several new disease areas, including alopecia areata, giant cell arteritis, and systemic lupus erythematosus. These potential new indications are expected to contribute significantly to the drug's future sales growth[4].

Long-Term Projections

AbbVie's long-term outlook for RINVOQ is robust, with expectations of continued growth into the next decade. The company's updated forecast reflects an increase of over $6 billion from its prior projections, highlighting the drug's potential to become a cornerstone in AbbVie's immunology portfolio[2].

Key Takeaways

• Clinical Efficacy: RINVOQ has demonstrated strong efficacy in clinical trials for ulcerative colitis, atopic dermatitis, and other conditions.
• Market Performance: RINVOQ is a key driver of AbbVie's revenue growth, with significant sales increases and projected future growth.
• Safety Considerations: The drug carries important safety warnings, necessitating careful patient monitoring.
• Competitive Position: RINVOQ has a strong competitive position with substantial growth potential.
• Future Outlook: The drug is expected to expand into new indications and contribute significantly to AbbVie's long-term growth.

FAQs

What are the primary indications for RINVOQ?

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis, ulcerative colitis, and atopic dermatitis.

How has RINVOQ performed in clinical trials for ulcerative colitis?

In clinical trials, RINVOQ has shown higher rates of clinical remission and endoscopic healing compared to placebo in patients with ulcerative colitis[1].

What are the projected sales figures for RINVOQ in 2024 and 2027?

RINVOQ and Skyrizi are expected to achieve $16 billion in combined sales in 2024, with RINVOQ alone projected to reach over $10 billion by 2027[2].

What safety concerns are associated with RINVOQ?

RINVOQ carries a boxed warning for serious infections, mortality, malignancies, major adverse cardiovascular events, and thrombosis[1].

Is RINVOQ considered a good value to the healthcare system?

According to CADTH, RINVOQ does not represent good value to the healthcare system at the public list price compared to other biologic or targeted synthetic drugs[3].

What new disease areas is RINVOQ being studied for?

RINVOQ is being studied in several new disease areas, including alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo[4].

Sources

1. RINVOQ® (upadacitinib) Efficacy for Ulcerative Colitis. RINVOQhcp.com.
2. As Humira plummets, AbbVie dials up Rinvoq and Skyrizi sales goals combined $27B. FiercePharma.
3. Upadacitinib (Rinvoq) - NCBI Bookshelf. NCBI.
4. New Analysis Demonstrates the Efficacy of RINVOQ® (upadacitinib) in Atopic Dermatitis with Varying Degrees of Head and Neck Involvement. AbbVie News.
5. AbbVie Raises 2024 Profit Outlook, Reports Strong Q1 Sales for Skyrizi and Rinvoq. BioSpace.