PMID- 34897575 OWN - NLM STAT- MEDLINE DCOM- 20220218 LR - 20240405 IS - 1179-1950 (Electronic) IS - 0012-6667 (Print) IS - 0012-6667 (Linking) VI - 82 IP - 1 DP - 2022 Jan TI - Ofatumumab: A Review in Relapsing Forms of Multiple Sclerosis. PG - 55-62 LID - 10.1007/s40265-021-01650-7 [doi] AB - Ofatumumab (Kesimpta((R))) is a fully human anti-CD20 monoclonal antibody that can be self-administered by patients and is approved in several countries worldwide for the treatment of relapsing forms of multiple sclerosis (MS). In two identical phase III trials in adults with relapsing forms of MS, subcutaneous ofatumumab was more effective than oral teriflunomide in reducing the annualized relapse rate, as well as reducing MRI-detected lesion activity and limiting worsening of disability. Ofatumumab had a generally manageable tolerability profile; the most common adverse events (AEs) included nasopharyngitis, headache, upper respiratory tract infections and urinary tract infections. AEs of special interest (AESIs) included infections and injection-related reactions, which were generally manageable. There was no apparent association between changes in immunoglobulin G or M levels and the risk of serious infections after 3.5 years of ofatumumab treatment. Thus, ofatumumab is a convenient treatment option that is effective and has a generally manageable tolerability profile in adults with relapsing forms of MS. CI - (c) 2021. Springer Nature. FAU - Kang, Connie AU - Kang C AD - Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. demail@springer.com. FAU - Blair, Hannah A AU - Blair HA AD - Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. LA - eng PT - Journal Article PT - Review PL - New Zealand TA - Drugs JT - Drugs JID - 7600076 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents) RN - M95KG522R0 (ofatumumab) SB - IM EIN - Drugs. 2021 Dec 29;:. PMID: 34964925 MH - Antibodies, Monoclonal, Humanized/adverse effects/pharmacology/*therapeutic use MH - Antineoplastic Agents/adverse effects/pharmacology/*therapeutic use MH - Clinical Trials as Topic MH - Humans MH - Multiple Sclerosis, Relapsing-Remitting/*drug therapy PMC - PMC8748350 OAB - MS is an incurable disease that affects approximately 2.8 million people worldwide. Limiting the progression of disability associated with this disease is crucial, and treatments such as teriflunomide or monoclonal antibodies can prevent the relapses which define MS. Ofatumumab (Kesimpta((R))), a monoclonal antibody, works by reducing the level of B cells which contribute to the development and progression of MS. Ofatumumab is approved in several countries worldwide to treat adults with certain relapsing forms of MS. It is administered by subcutaneous injection once per month and is the first therapy of its kind that patients can self-inject at home. In clinical trials, ofatumumab was more effective than teriflunomide in reducing the annual relapse rate, as well as slowing both the progression of disability and formation of new MS lesions in the brain. Ofatumumab had a generally manageable tolerability profile, although treatment resulted in infections and injection-related reactions; these were generally manageable with treatment. Thus, ofatumumab is an effective and convenient treatment option, with a generally manageable tolerability profile, in adults with relapsing forms of MS. OABL- eng COIS- Connie Kang and Hannah Blair are salaried employees of Adis International Ltd/Springer Nature, and declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content. EDAT- 2021/12/14 06:00 MHDA- 2022/02/19 06:00 PMCR- 2021/12/13 CRDT- 2021/12/13 13:31 PHST- 2021/12/14 06:00 [pubmed] PHST- 2022/02/19 06:00 [medline] PHST- 2021/12/13 13:31 [entrez] PHST- 2021/12/13 00:00 [pmc-release] AID - 10.1007/s40265-021-01650-7 [pii] AID - 1650 [pii] AID - 10.1007/s40265-021-01650-7 [doi] PST - ppublish SO - Drugs. 2022 Jan;82(1):55-62. doi: 10.1007/s40265-021-01650-7.