Here are some of the conditions we treat:

EARLY-STAGE ALZHEIMER’S DISEASE (AD) AND MILD COGNITIVE IMPAIRMENT DUE TO AD

Lecanemab (Leqembi®) is a monoclonal antibody that targets and removes amyloid beta plaques in the brain, which are believed to contribute to Alzheimer’s disease progression. The United States FDA fully approved the drug in July 2023. Lecanemab must be administered intravenously every 2 weeks. Patients receiving lecanemab showed a 27% slower rate of decline of decline over 18 months compared to those receiving a placebo. As measured by PET imaging, Lecanemab significantly reduced amyloid plaques in the brain.

Like lecanemab, donanemab (Kisunla®) is a monoclonal antibody that targets and removes amyloid beta in the brain. The FDA fully approved the drug in July 2024. However, donanemab is administered intravenously every 4 weeks. In the 18-month
TRAILBLAZER-ALZ-2 Phase 3 study, people who were the least advanced in the disease experienced the most substantial results with donanemab. Specifically, those individuals treated with donanemab who were less advanced in their disease showed a significant slowing of decline of 35% compared with placebo. In the overall population, the response to treatment was also statistically significant at 22%. Among the two groups analyzed, participants treated with donanemab had up to a 39% lower risk of progressing to the next clinical stage of disease than those taking a placebo. Among the overall population of participants, donanemab reduced amyloid plaques by 84% on average at 18 months compared to the start of the study.  The outcome measures used to evaluate lecanemab and donanemab were not the same, so it is important to avoid directly comparing the percent improvement in both drugs.

A baseline and follow-up lumbar puncture or Brain PET scan measuring amyloid protein is required to administer both drugs. Additionally, patients who use these medications must have a Brain MRI before starting treatment and several additional MRI scans during treatment, generally, at least 5 studies altogether. Sharlin Health Neuroscience Research Center was one of the largest enrolling sites globally for the TRAILBLAZER ALZ-2 study that led to FDA approval of donanemab. For patients, this means we have the most experience administering this type of medication than any other facility in the State of Missouri, helping to ensure the safety and oversight of administration. Also, we have extensive experience with lumbar punctures, and Sharlin Health Advanced Imaging offers onsite MRIs for a direct pay price of $499, including the radiology report, for your convenience. Amyloid PET scans are referred to outside institutions, pending approval by insurance carriers.

MULTIPLE SCLEROSIS (MS)

Two disease-modifying therapies, ocrelizumab (Ocrevus®) and ubituxumab (Briumvi®), are approved for intravenous infusion administration. Both are given IV every 6 months and are part of a class of medicines that target the CD-20 immune cell receptor. As a result, they destroy the over-active B cells, attacking the myelin that covers the nerves in the brain and spinal cord. These drugs are among the most effective treatments for multiple sclerosis, particularly the relapsing-remitting form. Ocrelizumab is also indicated for primary progressive multiple sclerosis.

For patients who may be experiencing a relapse of their multiple sclerosis, treatment with 3-5 days of high-dose intravenous methylprednisolone (Solumedrol®) may be necessary. Should one of our patients experience an exacerbation, we can treat them in the comfort of our clinic.

CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (CIDP)

Traditionally, treatment of CIDP has involved intravenous infusions of gamma globulin (IVIG). While several brands exist, IVIG is a pooled preparation of gamma globulin antibodies derived from human plasma donors. These preparations are screened for the absence of infectious diseases. It provides antibodies to block the immune and inflammatory processes that attack and destroy myelin. Generally, individual insurance coverers dictate which brand of IVIG they will cover. However, we obtain the IVIG for our patients and typically infuse daily over 2-5 days.

More recently, the drug VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) was approved for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo® is a once-weekly 30-to-90 second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP. While this medication does not require intravenous infusion therapy, there is an intravenous form of the drug that is approved to treat myasthenia gravis, another autoimmune neuromuscular disease (see below).

NEUROMYELITIS OPTICA (NMO)

The drugs eculizumab (Soliris®) and inebilizumab (Uplizna®) are specifically approved for NMO, although intravenous gamma globulin and the CD20 inhibitors for MS (see above) are likely efficacious. Eculizumab (Soliris®) is a monoclonal antibody (a type of protein) designed to attach to the C5 complement protein, a part of the body’s defense system called the complement system. By blocking complement C5, these therapies reduce inflammation and tissue destruction, helping to manage or prevent the damage caused by autoimmune diseases, like NMO. The drug is administered as an IV regimen every 2 weeks.

Like the anti-CD20 antibody drugs approved for multiple sclerosis, inebilizumab (Uplizna®) targets CD19-positive B cells, which drive inflammatory and fibrotic cascades and activate other cells involved in disease activity. Uplizna addresses this underlying disease process by binding to the CD19 surface protein and triggering the destruction of B cells. The drug, administered intravenously every 6 months, is approved in adults who are aquaporin-4 water channel autoantibody

(AQP4-IgG) positive. There is evidence that the anti-CD20 antibody drugs also have efficacy for NMO.

Historically, NMO has also been treated with intravenous gamma globulin and methylprednisolone infusions.

GENERALIZED MYASTHENIA GRAVIS (gMG)

Among the medications currently FDA-approved for generalized myasthenia gravis, three are administered intravenously: efgartigimod alfa (VYVGART®), eculizumab (Soliris®), and ravulizumab (Ultimiris®). The first two have already been covered, although the formulation of efgartigimod, currently approved for gMG, is an intravenous infusion in addition to the subcutaneous injection option. Ravulizumab (Ultimiris®) has a mechanism like the other two but is differentiated as the first long-acting complement inhibitor, infused every 8 weeks. Additionally, intravenous infusions of methylprednisolone and gamma globulin are mainstays of treatment for gMG.

MIGRAINE HEADACHES

The breakthrough class of medications for migraine headaches that have improved the quality of life for migraine sufferers in the past several years are collectively referred to as Calcitonin Gene-Related Peptide Inhibitors. Calcitonin Gene-Related Peptide (CGRP) is involved in the inflammatory cascade that is migraine, and the various ways in which CGRP is blocked can either abort an episode of migraine or reduce the frequency of migraine attacks over an extended time (“preventatives”). These medications come in several formulations. CGRP-inhibition is accomplished with oral tablets that are swallowed or dissolved in the mouth, nasal sprays, subcutaneous injections that have the advantage of being administered monthly or quarterly for migraine prevention, and in the case of epinezumab (Vyepti®), for 30 minutes quarterly as an intravenous infusion. This medication is well-tolerated and safe, and while not necessarily more effective than its subcutaneously injected counterparts, it reaches a peak blood level more quickly. Some patients prefer it and on an individual basis, prefer IV epinezumab over the subcutaneously injected CGRP inhibitors.