Latest news with #adalimumab
Health Line
3 days ago
- Health
- Health Line
Does Humira Cause Hair Loss?
Is hair loss common Hair loss is a potential but uncommon side effect of Humira (adalimumab). Hair loss wasn't reported during the drug's studies, but has been reported since Humira was approved for use. Humira is a prescription medication used to treat a number of chronic (ongoing) autoimmune and inflammation-related conditions in adults and some children. How common is hair loss with Humira? Hair loss is considered a rare side effect of Humira, since there were no reports of this side effect in the drug's studies. Since Humira came on the market, there have been reports of hair loss, but it's unclear how many people were affected or if Humira was the actual cause. In one small study, there were 62 cases of different types of hair loss reported by people who had taken a TNF blocker. (This is the group of drugs Humira belongs to.) These people typically lost a few small patches of hair during TNF-blocker treatment, but their hair often grew back after the treatment ended. How TNF blockers cause hair loss is uncertain. Hair loss may be an autoimmune response to the condition the drug is being taken to treat, a side effect of the drug itself, or caused by another reason entirely.
Medscape
14-07-2025
- Health
- Medscape
TNF Inhibitors Linked to Lower PsA Risk in Severe Psoriasis
TOPLINE: In patients with chronic plaque psoriasis, long-term treatment with TNF inhibitors was associated with a lower risk for psoriatic arthritis (PsA) than narrow-band ultraviolet B phototherapy. METHODOLOGY: In a longitudinal cohort study, researchers included 946 adult patients treated for chronic plaque psoriasis between September 2005 and September 2010. Two propensity score-matched groups with 297 patients each were formed: those who received TNF inhibitors, including etanercept, infliximab, and adalimumab (mean age, 52.2 years; 65.7% men), and phototherapy using narrow-band ultraviolet B (mean age, 51.5 years; 64.6% men). Patients underwent a rheumatologist assessment before therapy initiation. The incidence of PsA was assessed over a mean follow-up duration of 9.1 and 8.9 years per person for those who received TNF inhibitors and phototherapy, respectively. TAKEAWAY: The incidence rate of PsA per 100 patients with psoriasis was 1.18 among those who received TNF inhibitors and 2.48 among those who received phototherapy (incidence rate ratio, 2.1; P = .0002). Treatment with TNF inhibitors was associated with a significantly lower risk for PsA than phototherapy (adjusted hazard ratio [aHR], 0.32; P < .0001), which was noted across different psoriasis severities (on the basis of Psoriasis Area and Severity Index [PASI] scores). Arthralgia was the strongest independent predictor of the risk for PsA (aHR, 7.68; P < .0001), followed by nail psoriasis (aHR, 1.93; P = .0004) and higher baseline PASI scores (aHR, 1.03 per point increase; P = .0096). IN PRACTICE: "A multidisciplinary approach involving dermatologists and rheumatologists in identifying and managing arthralgia could be crucial in modifying disease progression," the authors wrote. SOURCE: This study was led by Stefano Piaserico, MD, PhD, Department of Medicine, University of Padua, Padua, Italy. It was published online on July 03, 2025, in Rheumatology. LIMITATIONS: Unmeasured confounding factors may have influenced the outcomes. All the patients were recruited from psoriasis referral centres, potentially overrepresenting those with more severe or long-duration disease. Certain TNF inhibitors, such as certolizumab and golimumab, were not included. DISCLOSURES: This study did not receive any specific funding. Several authors reported serving as consultants, speakers, and/or advisors for and receiving honoraria from various pharmaceutical companies including AbbVie, Eli Lilly, and Novartis. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
03-07-2025
- Health
- Medscape
Meta-Analysis Compares Hidradenitis Suppurativa Treatments
TOPLINE: In a network meta-analysis of 25 randomized trials, sonelokimab was ranked highest for treating patients with moderate-to-severe hidradenitis suppurativa (HS). Adalimumab, lutikizumab, and bimekizumab were also ranked high. METHODOLOGY: Researchers conducted a systematic review and network meta-analysis of 25 phase 2 and 3 randomized clinical trials of medical treatments for adults with moderate-to-severe HS (up to June 28, 2024), with primary efficacy assessments performed between 12 and 16 weeks. The trials included 5767 patients with moderate-to-severe HS and 39 unique treatments, including the three approved treatments in the US and Europe: adalimumab, secukinumab, and bimekizumab. Primary outcomes were the HS Clinical Response of at least 50% (HiSCR-50), serious adverse events, and discontinuation due to adverse events. Researchers also reported HiSCR-75. TAKEAWAY: Compared with placebo, significantly higher HiSCR-50 responses were noted for sonelokimab, 120 mg, every 4 weeks (odds ratio [OR], 4.44; 95% CI, 2.29-8.61) and 240 mg (OR, 2.62; 95% CI, 1.37-5.00); lutikizumab, 300 mg, every 2 weeks (OR, 2.72; 95% CI, 1.08-6.86); adalimumab, 40 mg, once weekly (OR, 2.63; 95% CI, 2.06-3.36); bimekizumab, 320 mg, every 2 weeks (OR, 2.63; 95% CI, 2.06-3.36) and every 4 weeks (OR, 2.27; 95% CI, 1.52-3.39); povorcitinib, 15 mg, once per day (OR, 2.28; 95% CI, 1.02-5.13); and secukinumab, 300 mg, every 2 weeks (OR, 1.60; 95% CI, 1.18-2.16) and every 4 weeks (OR, 1.62; 95% CI, 1.20-2.20). Compared with placebo, higher HiSCR-75 responses (a secondary endpoint) were noted for sonelokimab, 120 mg, every 4 weeks (OR, 4.12; 95% CI, 2.00-8.51); lutikizumab, 300 mg, every 2 weeks (OR, 4.01; 95% CI, 1.40-11.47) and once weekly (OR, 2.95; 95% CI, 1.03-8.42); bimekizumab, 320 mg, every 2 weeks (OR, 2.91; 95% CI, 1.89-4.49); sonelokimab, 240 mg, every 4 weeks (OR, 2.89; 1.38-6.06); adalimumab, 40 mg, once per week (OR, 2.85; 95% CI, 1.89-4.30); bimekizumab, 320 mg, every 4 weeks (OR, 2.26; 95% CI, 1.39-3.66); and secukinumab, 300 mg, every 4 weeks (OR, 2.04; 95% CI, 1.39-3.00) and every 2 weeks (OR, 1.85; 95% CI, 1.26-2.73). Sonelokimab, 120 mg, every 4 weeks was the top treatment for both HiSCR-50 and HiSCR-75. Other high-rated treatments were adalimumab, 40 mg, once per week; sonelokimab, 240 mg, every 4 weeks; lutikizumab, 300 mg, every 2 weeks; and bimekizumab, 320 mg, every 2 weeks. Serious adverse event rates ranged from 0% to 10% for placebo, 0% to 8% for adalimumab (40 mg once per week), and 0% to 6% for other active treatment groups. Discontinuation rates due to adverse events were 0%-10%, 0%-4%, and 0%-15%, respectively. IN PRACTICE: The network meta-analysis 'provides evidence for the comparative efficacy and safety of currently approved cytokine inhibitors for moderate to severe HS in the absence of head-to-head trials,' the authors of the study wrote. 'Phase 2 results for several cytokine and small-molecule treatments are promising and require confirmation in larger phase 3 trials,' they added. SOURCE: The study was led by Amit Garg, MD, Department of Dermatology, Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, and was published online on July 2 in JAMA Dermatology. LIMITATIONS: Limitations were reliance on indirect evidence for most comparisons, small sample size for individual treatment groups, and short follow-up. DISCLOSURES: The authors reported no funding information. Garg declared receiving grants and personal fees from AbbVie, Almirall, Boehringer Ingelheim, Engitix, Immunitas Therapeutics, Incyte, Insmed, Novartis, Pfizer, Priovant Therapeutics, Sonoma Biotherapeutics, Sun Pharma, UCB, UNION Therapeutics, and Zura Bio, and having a patent for an HS Investigator Global Assessment and a licensed patent for HS quality of life. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
National Post
27-05-2025
- Business
- National Post
US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon HADLIMA™ (adalimumab-bwwd) Injection
Article content HADLIMA™ (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of Humira (adalimumab) 1,2 The interchangeability designation for HADLIMA is based on a Pharmacokinetics, Efficacy, Safety, and Immunogenicity study of SB5 versus Humira in patients with moderate to severe chronic plaque psoriasis 3 An interchangeable biosimilar product may be substituted for the reference product without consulting the prescriber, subject to state pharmacy laws 4 Article content Article content INCHEON, Korea & JERSEY CITY, N.J. — Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira ® (adalimumab). 2 These interchangeability designations follow the interchangeability designation received for the HADLIMA low-concentration (40 mg/0.8 mL) prefilled syringe and single-dose vial in June 2024. 1 With today's additional interchangeability designations, HADLIMA is now interchangeable with all presentations of the reference product. 1,2 An interchangeability designation enables a pharmacist to substitute the reference product with a biosimilar without the need to consult the prescriber, depending on state pharmacy laws. 4 Article content 'An increased uptake of biosimilars may lead to improved patient access to biologic therapies and potential savings for the US health care system. 5 As a company dedicated to making medicines more accessible, HADLIMA, now designated as fully interchangeable with the reference product, has a greater potential to bring savings for patients. 1,2,5 As our data shows, on average, patients paid more than four times as much out of pocket per month for Humira compared to HADLIMA,' *6 said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon. 'With this approval, pharmacies can substitute HADLIMA for the reference product Humira without consulting prescribers (subject to state law), which may facilitate increased access for patients to receive the medications they need.' 4,5 Article content 'This designation is meaningful as it signifies our continued commitment to making biosimilars more accessible. Both biosimilars and interchangeable biosimilars are highly similar and have no clinically meaningful differences in safety, purity, and potency compared to the reference product,' 7 said Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. 'With this designation, we continue to benefit patients, health care providers, and health care systems around the world.' Article content HADLIMA is a tumor necrosis factor (TNF) blocker indicated for appropriate patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. See full indications below. Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Discontinue HADLIMA if a patient develops a serious infection or sepsis. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of tuberculosis (TB) in patients who tested negative for latent TB infection prior to initiating therapy. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. See additional safety information below. Article content The interchangeability designation was based on clinical data from a randomized, double-blind, 1:1 ratio, parallel-group, multiple-dose clinical trial, which assessed pharmacokinetics (PK), efficacy, safety, and immunogenicity in two treatment groups: patients with moderate to severe plaque psoriasis who switched between formulations of EU-sourced Humira and high-concentration SB5 (adalimumab biosimilar) versus patients receiving Humira continuously. The study demonstrated comparability in terms of primary PK endpoints, as well as efficacy, safety, and immunogenicity profiles between the switching group and continuous Humira treatment group. 3 In addition, data from additional studies provide further evidence to support the interchangeability designation for HADLIMA low- and high-concentration autoinjectors. 8 Article content HADLIMA was first approved by the FDA in 2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and autoinjector. The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and autoinjector of HADLIMA was approved in 2022. 9 Both low- and high-concentration formulations of HADLIMA have been commercially available in the US market since 2023. 10 Article content Rheumatoid Arthritis: HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), 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. Juvenile Idiopathic Arthritis: HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Psoriatic Arthritis: HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Ankylosing Spondylitis: HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn's Disease: HADLIMA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis: HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers. Plaque Psoriasis: HADLIMA 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. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa: HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis: HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. Article content Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Article content Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients: Article content Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Article content Do not start HADLIMA during an active infection, including localized infections. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. If an infection develops, monitor carefully and initiate appropriate therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HADLIMA with other biologic DMARDs (eg, anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. Article content Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Article content Consider the risks and benefits of HADLIMA treatment prior to initiating or continuing therapy in a patient with known malignancy. In clinical trials, more cases of malignancies were observed among adalimumab-treated patients compared to control patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA. In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. Article content Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy. Article content Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Article content Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Article content Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment. Article content Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment. Article content TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Article content Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop. Article content HEMATOLOGIC REACTIONS Article content Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Article content Consider stopping HADLIMA if significant hematologic abnormalities occur. Article content CONGESTIVE HEART FAILURE Article content Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully. Article content Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop. Article content IMMUNIZATIONS Article content Patients on HADLIMA should not receive live vaccines. Article content Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy. Article content Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero -exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. Article content ADVERSE REACTIONS Article content The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash. Article content Before prescribing HADLIMA, please read the Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for Use also are available. Article content Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing health care that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: and follow us on social media – X, LinkedIn. Article content Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon's diverse portfolio offers over 70 medicines and products in women's health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon's current products, the company invests in innovative solutions and research to drive future growth opportunities in women's health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon's scale and agile presence in fast growing international markets. Article content Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. Article content HADLIMA is developed, manufactured and supplied by Samsung Bioepis, and commercialized by Organon. Samsung Bioepis and Organon have development and commercialization collaborations for two immunology products and one oncology product in the United States. Article content © 2025 Organon group of companies. All rights reserved. ORGANON and the ORGANON Logo are trademarks of the Organon group of companies. Article content HUMIRA is a trademark registered in the US by AbbVie Biotechnology Ltd.; Organon is not associated with this trademark owner. Article content Except for historical information, this press release includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the potential benefits of biosimilars, as well as Organon's and Samsung's collaboration and the benefits thereof. Forward-looking statements may be identified by words such as 'may,' 'potential,' 'can,' 'should,' 'continue,' 'will,' 'expects,' 'future,' 'opportunity,' or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, expanded brand and class competition in the markets in which Organon operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon's customers and business partners; economic factors over which Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; market volatility, downgrades to the U.S. government's sovereign credit rating or its perceived creditworthiness, changing political or geopolitical conditions, market contraction, boycotts, and sanctions, as well as Organon's ability to successfully manage uncertainties related to the foregoing; difficulties with performance of third parties Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; restructurings or other disruptions at the FDA, the U.S. Securities and Exchange Commission ('SEC') and other U.S. and comparable government agencies; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of Organon's products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon's business; efficacy, safety or other quality concerns with respect to Organon's marketed products, whether or not scientifically justified, leading to product recalls, withdrawals or declining sales; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health care insurance coverage; legal factors that could preclude commercialization of products or negatively affect the profitability of existing products; the failure by Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of Organon's products; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or ability to supply Organon's products. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon's filings with the SEC, including Organon's most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC's Internet site ( Article content *Based on an analysis of actual patient claims processed from July 2023 to August 2024, with the average out-of-pocket costs being $215 vs $48 for HUMIRA and HADLIMA, respectively. Article content 1 Approval letter for HADLIMA (adalimumab-bwwd) supplemental biologics license application 761059/S-018. U.S. Food and Drug Administration. June 2024. Article content 2 Approval letter for HADLIMA (adalimumab-bwwd) supplemental biologics license applications 761059/S-025 and 761059/S-026. U.S. Food and Drug Administration. May 2025. Article content 3 Feldman S, Valiukeviciene S, Pulka G, et al. Interchangeability of SB5 and adalimumab reference product in patients with moderate to severe chronic plaque psoriasis. Poster presented at: American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA. Accessed May 2025. Article content 4 US Food and Drug Administration. Biosimilar and interchangeable biologics; more treatment choices. Updated August 17, 2023. Accessed May 14, 2025. Article content 5 Aitken M, Kleinrock M, Pritchett J. Biosimilars in the United States 2023-2027: competition, savings, and sustainability. IQVIA Institute for Human Data Science. January 31, 2023. Accessed March 5, 2025. Article content 6 Data available on request from Organon Professional Services-DAP (Marketing Operations), 30 Hudson St., Jersey City, NJ 07302. Please specify information package REF-146241. Article content 7 Biosimilars: Review and approval. US Food and Drug Administration. December 13, 2022. Accessed May 16, 2025. Article content Article content Article content Article content Article content Contacts Article content Organon Media Contacts: Felicia Bisaro (646) 703-1807 Kate Vossen (732) 675-8448 Article content Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129 Article content Article content
Health Line
23-05-2025
- Health
- Health Line
Humira Overview: Uses, Dosage, Side Effects, and More
Humira (adalimumab) is a prescription drug that's used to treat certain types of arthritis and other inflammation-related diseases. It comes as a liquid solution for injection under your skin. Specifically, Humira is used to treat: rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis in adults plaque psoriasis in adults juvenile idiopathic arthritis in children Crohn's disease and ulcerative colitis in adults and some children hidradenitis suppurativa (a skin condition) in adults and some children uveitis (an eye condition) in adults and some children To learn more about Humira's uses, see the ' What is Humira used for? ' section. What is Humira? Humira (pronounced hu-MARE-ah) is a biologic medication. A biologic is made from parts of living organisms. The active ingredient in Humira is adalimumab. (An active ingredient is what makes a medication work.) There are also biosimilar versions of Humira, such as Amjevita, Cyltezo, and others. Biosimilar drugs are medications that are similar to a brand-name biologic drug. Biosimilars are considered as safe and effective as brand-name biologic drugs and tend to cost less. Humira belongs to a group of drugs called tumor necrosis factor inhibitors, which help reduce inflammation in the body. What is Humira used for? If you have a certain type of arthritis or a disease related to inflammation, your doctor may prescribe Humira for you. Humira is used in certain situations to treat the following conditions: Rheumatoid arthritis: Humira is used to treat rheumatoid arthritis (RA) in adults. The drug can help slow the worsening of this condition. With RA, you have inflammation in your joints. But you may also have problems with other organs in your body. Juvenile idiopathic arthritis: Humira is used to treat moderate to severe juvenile idiopathic arthritis (JIA) in children ages 2 years and older. JIA is a type of arthritis that occurs in children. Psoriatic arthritis: Humira is used to treat psoriatic arthritis (PsA) in adults. The drug helps to slow the worsening of this condition. With PsA, you have inflammation in your joints, and you may also have plaques on your skin, similar to those seen with plaque psoriasis (see below). Ankylosing spondylitis: Humira is used to treat ankylosing spondylitis (AS) in adults. AS and RA are very similar diseases. But people with AS usually have long-lasting lower back pain. This is unlike people with RA, who usually have long-lasting pain in joints in their hands, wrists, or knees. Crohn's disease: Humira is used to treat moderate to severe Crohn's disease in adults and children ages 6 years and older. Crohn's disease is an inflammatory disease that causes swelling in your intestines. Ulcerative colitis: Humira is used to treat moderate to severe ulcerative colitis (UC) in adults and children ages 5 years and older. With UC, you have swelling in your lower intestine. Plaque psoriasis: Humira is used to treat moderate to severe plaque psoriasis in adults. With plaque psoriasis, you may have plaques on the skin of your scalp or trunk, or the skin around your joints. (Plaques are rough, thick, or scaly patches.) Some people with plaque psoriasis develop psoriatic arthritis. Hidradenitis suppurativa: Humira is used to treat moderate to severe hidradenitis suppurativa (HS) in people ages 12 years and older. HS is a skin condition that causes sores on your underarm (axilla) or groin, around your anus, between your anus and urethra, and under your breasts. Uveitis: Humira is used to treat uveitis in adults and children ages 2 years and older. With uveitis, you have inflammation in your eyes that can cause pain and vision loss. How does Humira work? Adalimumab, the active ingredient in Humira, targets a protein in your body called tumor necrosis factor (TNF). This protein increases inflammation in your body. People with inflammatory diseases, such as rheumatoid arthritis or psoriatic arthritis, may have too much TNF in their bloodstream and joints. Blocking TNF is how Humira works for the conditions listed above. What is Humira's dosage? The Humira dosage your doctor prescribes will depend on several factors. These include: the type and severity of the condition you're using Humira to treat your age other medical conditions you may have For some conditions, you may need to start treatment with a loading dose of Humira. A loading dose is a dose that's larger than your regular dose. It allows the drug to start working quickly in your body. Be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs. How to take Humira You'll inject Humira under your skin. Your doctor will show you how to give Humira injections to yourself. Be sure to let your doctor know if you have any questions or concerns about administering the drug to yourself. You'll inject Humira under the skin of: your abdomen, staying 2 inches away from your belly button the front of your thighs Every time you inject a dose of Humira, you should choose a different injection site. And each new injection should be given at least 1 inch away from your last injection site. You should avoid injecting Humira into skin that's: sore bruised discolored hard scarred, including having stretch marks Questions about taking Humira Here are answers to some common questions about taking Humira. What if I miss a dose of Humira? If you miss a dose of Humira, take the missed dose as soon as you remember. Then continue taking Humira doses at your regularly scheduled times. How many days late you can take a Humira dose depends on when your next dose is scheduled. So if it's close to when your next dose is due, just skip the missed dose. If you're unsure of when to take a missed dose of Humira, talk with your doctor or pharmacist. Will I need to use Humira long term? You'll likely need to take Humira long term. This is because most of the conditions Humira treats are long lasting. Talk with your doctor about how long you'll need to take Humira. Should I take Humira with food? You don't have to. How well your body absorbs Humira doesn't depend on whether you have a full or empty stomach. How long does Humira take to work? Depending on the reason you're taking Humira, it may take several months for the drug to work. For example, in studies, people with rheumatoid arthritis saw improvement in their condition after 6 months of treatment. And this improvement was maintained after 1 year when treatment was continued. You might notice Humira working sooner than this for your condition. Talk with your doctor to find out when you should expect to experience a reduction in your symptoms. Overdose Do not take more Humira than your doctor prescribes, as this can lead to harmful effects. What to do in case of overdose Call your doctor if you think you've taken too much Humira. You can also call 800-222-1222 to reach America's Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or go to the nearest emergency room. What are Humira's side effects? Like most drugs, Humira may cause mild to serious side effects. The following lists contain some of the more common side effects Humira may cause, but they don't include all possible side effects. Keep in mind that side effects of a drug can depend on: your age other health conditions you have other medications you take The most common Humira side effects reported in the drug's prescribing information include: upper respiratory infections sinusitis injection site reactions headache rash What does Humira cost? Whether you have health insurance or not, cost may be a factor when you're considering Humira. What you'll pay for Humira may depend on several things, such as your treatment plan and the pharmacy you use. Here are a few things to consider regarding cost: Cost information and savings coupons: You can visit Optum Perks for price estimates of Humira. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with insurance copays or benefits. Generic or biosimilar form: Humira is available as the biosimilar drug Amjevita. Similar to generic drugs, biosimilars often cost less than brand-name drugs. Talk with your doctor if you'd like to know whether Amjevita or another biosimilar version of Humira could be a less expensive option for you. Savings options: If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. The Humira manufacturer's website may also have some savings options. Humira interactions Humira can interact with several other medications. It can also interact with certain vaccines. Before using Humira, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, or supplements you use. Sharing this information can help you avoid potential interactions. Similar drugs Other drugs may be available that can treat your condition. If you'd like to explore an alternative to Humira, talk with your doctor. They can tell you about other medications that might work well for you. The following drugs are similar to Humira: etanercept (Enbrel) infliximab (Remicade) ustekinumab (Stelara) secukinumab (Cosentyx) vedolizumab (Entyvio) upadacitinib (Rinvoq) certolizumab (Cimzia) risankizumab-rzaa (Skyrizi) tofacitinib (Xeljanz) For information about how some of these alternatives compare with Humira, see these articles: Factors to consider before using Humira The following is important information to consider and discuss with your doctor or pharmacist before using Humira. Pregnancy and Humira Adalimumab, the active ingredient in Humira, passes through the placenta to the developing fetus during the last trimester of pregnancy. But studies don't show a link between Humira use and development problems in pregnancy. It's thought that having unmanaged rheumatoid arthritis or inflammatory bowel disease (such as Crohn's disease) can negatively affect pregnancy. And keep in mind that Humira is used for those conditions. Also, because of how Humira works, doctors will weigh the benefits and risks of giving certain vaccines to babies exposed to Humira during the last trimester of pregnancy. If you're pregnant or considering pregnancy, talk with your doctor before starting Humira. Humira and breastfeeding Humira does pass into breast milk. But side effects from Humira in children who are breastfed haven't been reported. Also, Humira doesn't seem to decrease milk production in people who are breastfeeding. If you're breastfeeding, your doctor will weigh the benefits and risks of Humira treatment. Be sure to talk with your doctor if you'll be breastfeeding while taking Humira. Humira precautions Boxed warnings Humira has boxed warnings about the risk of serious infections and cancer. A boxed warning is the most serious warning from the FDA about drug effects that may be dangerous. Risk of serious infections. Taking Humira can increase your risk for getting a serious infection. This includes tuberculosis, fungal infections, and other rare infections. It may also include bacterial sepsis (a life threatening illness that can result from an infection). Symptoms of a serious infection will vary, but they may include: breathing quickly fast heart rate being confused or disoriented fever chills rash cough If you develop a serious infection or sepsis while you're taking Humira, your doctor will have you stop taking the drug. Call your doctor right away if you have any symptoms of infection while using this drug. Your doctor will also check you for tuberculosis before you start using Humira. And during treatment with Humira, your doctor will monitor you for any signs or symptoms of tuberculosis. Risk of cancer. Some children and adolescents have developed certain types of cancer when taking Humira, such as lymphoma. (This is a type of cancer that affects the lymphatic system.) Other cancers that can be fatal were also reported. Before prescribing Humira, your doctor will consider the benefits and risks of using this drug if you already have cancer. If you develop cancer while you're taking Humira, your doctor will also weigh the benefits and risks of Humira treatment. Your doctor may recommend that you stop taking Humira. Other precautions Before using Humira, discuss your health history with your doctor. Humira may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you: Frequently asked questions about Humira Here are answers to some commonly asked questions about Humira. Does Humira cause weight gain or weight loss? No, Humira doesn't cause weight gain or weight loss. But if you get a serious infection during Humira treatment, you might lose weight. And serious infections are a possible side effect of this drug. Also, new or worsening heart failure can cause a rapid increase in weight. Heart failure is a possible side effect of Humira. If you have unexplained weight gain or weight loss when using Humira, tell your doctor. They can try to determine what might be causing your weight change. If you're concerned about any other weight changes while you're taking Humira, talk with your doctor. They can provide tips to help you manage a body weight that's healthy for you. Will I have hair loss with Humira? Possibly. Hair loss wasn't reported as a side effect in Humira's studies. But there have been reports of hair loss in people taking Humira since the drug was approved. If you notice you're losing hair while you're taking Humira, talk with your doctor. What will happen if I stop taking Humira? Will I have withdrawal symptoms? If you stop taking Humira, the symptoms of your condition may come back. But you won't have withdrawal symptoms from the medication itself. (Withdrawal refers to symptoms that can happen if you stop taking a medication that your body is dependent on. Dependence means the body needs the medication to function like usual.) If you need to stop taking Humira, your doctor will closely monitor you for symptoms of your condition. If your symptoms return, your doctor may recommend that you restart treatment with Humira. Or they may suggest another drug to manage your condition. Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
