FDA approved Yusimry (adalimumab) for Multiple Inflammatory ConditionsFDA approved Yusimry for Several Inflammatory Conditions

FDA From the archive Source published December 17, 2021 Summary added September 29, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note: Yusimry is not effective

The FDA has approved Yusimry (adalimumab), a tumor necrosis factor (TNF) blocker, for a range of inflammatory conditions. The approval covers rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and non-infectious uveitis. Yusimry is administered by subcutaneous injection and offers another treatment option for patients with these chronic diseases.

The approval is based on the established efficacy and safety profile of adalimumab. However, the label notes that effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. For ulcerative colitis, treatment should be discontinued in patients without evidence of clinical remission by eight weeks. In plaque psoriasis, Yusimry should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Clinicians should refer to the full prescribing information for detailed dosing and administration across the different indications.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Yusimry is a tumor necrosis factor (TNF) blocker. The label does not provide a detailed mechanism of action.

Indication & Patient Population

Yusimry is indicated for: - Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting progression of structural damage, and improving physical function in adults with moderately to severely active RA. Can be used alone or with methotrexate or other non-biologic DMARDs. - Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years and older. Can be used alone or with methotrexate. - Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting progression of structural damage, and improving physical function in adults with active PsA. Can be used alone or with non-biologic DMARDs. - Ankylosing Spondylitis (AS): reducing signs and symptoms in adults with active AS. - Crohn's Disease (CD): treatment of moderately to severely active CD in adults and pediatric patients 6 years and older. - Ulcerative Colitis (UC): treatment of moderately to severely active UC in adults. - Plaque Psoriasis (Ps): treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Should only be administered to patients who will be closely monitored and have regular follow-up visits. - Hidradenitis Suppurativa (HS): treatment of moderate to severe HS in adults. - Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.

Dosing & Administration

Administered by subcutaneous injection. - RA, PsA, AS: Adults: 40 mg every other week. Some RA patients not receiving methotrexate may benefit from increasing to 40 mg every week or 80 mg every other week. - JIA: Pediatric patients 2 years and older weighing 30 kg or greater: 40 mg every other week. - CD: Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29. Pediatric patients 6 years and older weighing 40 kg or greater: Day 1: 160 mg (single dose or split over two consecutive days); Day 15: 80 mg; starting on Day 29: 40 mg every other week. - UC: Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15, and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57). - Plaque Psoriasis or Adult Uveitis: Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose. - HS: Adults: Day 1: 160 mg (given in one day or split over two consecutive days); Day 15: 80 mg; Day 29 and subsequent doses: 40 mg every week or 80 mg every other week.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

The label does not list contraindications or warnings in the provided text. Please refer to the full prescribing information.

Place in Therapy

Yusimry is a TNF blocker approved for multiple inflammatory conditions. It provides an additional treatment option for patients with these diseases. The limitation of use in patients who have lost response to or were intolerant to TNF blockers should be considered when selecting therapy.

Yusimry is a new injectable medicine approved by the FDA. It is a tumor necrosis factor blocker, which means it works by reducing inflammation in the body. The drug is approved to treat a range of chronic inflammatory conditions. These include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and non-infectious uveitis.

Yusimry is given as a shot under the skin. It is meant for people with these ongoing conditions who may need another treatment option. The approval is based on the known safety and effectiveness of adalimumab, the active ingredient in Yusimry.

There are some important limits. The drug has not been shown to work in patients who have already lost response to or cannot tolerate other TNF blockers. For ulcerative colitis, treatment should stop if there is no sign of remission by eight weeks. For plaque psoriasis, patients should be closely watched by a doctor with regular follow-up visits.

This approval adds a new choice for some patients, but it is not a cure and not right for everyone. If you have one of these conditions, talk with your doctor about whether Yusimry could be an option for you.

What this means for you:

Yusimry is a new injectable option for certain inflammatory conditions, but ask your doctor if it is right for you.

Study Details

Study typeFda approval

PublishedDec 2021

View Original Abstract ↓

1 INDICATIONS AND USAGE YUSIMRY is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1.1 ): 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. Juvenile Idiopathic Arthritis (JIA) ( 1.2 ): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Psoriatic Arthritis (PsA) ( 1.3 ): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. Ankylosing Spondylitis (AS) ( 1.4 ): reducing signs andsymptoms in adult patients with active AS. Crohn's Disease (CD) ( 1.5 ): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis (UC) ( 1.6 ): 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. Plaque Psoriasis (Ps) ( 1.7 ): 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. Hidradenitis Suppurativa (HS) ( 1.8 ): treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis (UV) ( 1.9 ): The treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. 1.1 Rheumatoid Arthritis YUSIMRY is indicated for 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 rheumatoid arthritis. YUSIMRY can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis YUSIMRY is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. YUSIMRY can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis YUSIMRY is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. YUSIMRY can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis YUSIMRY is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease YUSIMRY is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis YUSIMRY is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 ) ]. 1.7 Plaque Psoriasis YUSIMRY is indicated for the 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. YUSIMRY should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions ( 5 ) ]. 1.8 Hidradenitis Suppurativa YUSIMRY is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis YUSIMRY is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

FDA approved Yusimry (adalimumab) for Multiple Inflammatory ConditionsFDA approved Yusimry for Several Inflammatory Conditions

Study Details

Evaluating the Efficacy of Traditional Chinese Medicine Decoctions for Rheumatoid Arthritis Management

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FDA approved Yusimry (adalimumab) for Multiple Inflammatory ConditionsFDA approved Yusimry for Several Inflammatory Conditions

Study Details

Evaluating the Efficacy of Traditional Chinese Medicine Decoctions for Rheumatoid Arthritis Management

Traditional Chinese medicine decoctions may improve rheumatoid arthritis symptoms

Clinical research that matters. Delivered to your inbox.

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