First therapy for rare autoimmune disorder
Amifampridine (Firdapse) is the first drug approved by the FDA to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder that affects neuromuscular junction transmission. The primary clinical manifestation is muscle weakness. Although LEMS may be associated with other autoimmune diseases, it more commonly occurs in patients with cancer, such as small-cell lung cancer.
The new drug was tested in two clinical trials that included 64 adult patients who received either amifampridine or placebo. Patient response was measured with a 13-item physician-rated categorical scale assessing muscle weakness and a seven-point scale on which patients rated their overall impression of how treatment affected their physical well-being. Patients receiving amifampridine experienced a greater benefit on both measures compared with those taking a placebo.
Amifampridine is administered orally. To facilitate the approval process, the FDA granted it priority, breakthrough therapy, and orphan drug designations.
Source: US Food & Drug Administration. FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder. News release. November 28, 2018.
Guidelines for assessing reported penicillin allergy
Although an estimated 10% of the US population has reported an allergy to the beta-lactam agent penicillin, clinically significant IgE-mediated or T lymphocyte–mediated penicillin hypersensitivity is rare. Overdiagnosis of penicillin allergy may lead to costly or inappropriate alternative treatments and contribute to adverse reactions.
In a consensus article, experts representing major professional organizations conducted a literature review and a review of professional practice guidelines to outline best practices for assessing penicillin allergy. Among the findings and recommendations:
- a direct amoxicillin challenge is appropriate for patients with low-risk allergy histories. These include patients with a history of isolated nonallergic signs and symptoms such as gastrointestinal symptoms, a family history of a penicillin allergy but no such personal history, pruritus without rash following penicillin administration, or an unknown reaction to penicillin more than 10 years ago.
- penicillin skin testing is appropriate for moderate-risk patients, such as those experiencing urticaria or other pruritic rashes or any reaction with features of an IgE-mediated reaction.
- patients at high risk include those with histories of anaphylaxis, positive penicillin skin testing, recurrent penicillin reactions, or hypersensitivities to multiple beta-lactam antibiotics.
The authors state that the goals of antimicrobial stewardship are undermined when reported allergy to penicillin leads to use of broad-spectrum antibiotics that increase the risk of antimicrobial resistance. “Evaluation of penicillin allergy before deciding not to use penicillin or other beta-lactam antibiotics is an important tool for antimicrobial stewardship.”
Authors contributing to the consensus article included representatives from the American Academy of Allergy, Asthma & Immunology, the Infectious Diseases Society of America, and the Society for Healthcare Epidemiology of America.
Sources: Shenoy ES, Macy E, Rowe T, Blumenthal KG. Evaluation and management of penicillin allergy: a review. JAMA. 2019;321(2):188-199. Review shares best practices for evaluating penicillin allergy. HealthDay News. January 16, 2019.
ERAS protocol cuts post-op opioid use
A novel enhanced recovery after surgery (ERAS) protocol was shown to significantly reduce patients' opioid requirements following elective spine or peripheral nerve surgery. ERAS protocols are designed to enhance patient safety and recovery by addressing pre-, peri-, and postoperative factors in a patient's surgical journey.
The study compared 201 patients who received the ERAS protocol with a historical cohort of 74 patients who had received traditional care. Care for the intervention group was based on a unique ERAS protocol created by the Department of Neurosurgery at the University of Pennsylvania. Primary objectives were opioid and nonopioid pain medication consumption, need for opioid use at 1 month postoperatively, and patient-reported pain scores. Secondary objectives were mobilization and ambulation status, urinary catheter use, need for straight catheterization, length of stay, need for ICU admission, discharge status, and readmission within 30 days.
The use of I.V. opioid medications via patient-controlled analgesia was nearly eliminated in the ERAS group, with no change in daily or average pain scores. At 1 month following surgery, about 39% of patients in the intervention group were using opioids, compared with 53% of those in the control group. Among secondary outcomes, patients in the ERAS group achieved greater mobilization on post-op day 0 and 1, and post-op use of indwelling urinary catheter use was lower in the ERAS group (20% versus 47%) without an increase in the rate of straight catheterization.
The authors conclude that by engaging each aspect of a patient's surgical journey, ERAS protocols can decrease reliance on opioids and optimize clinical outcomes.
Source: Ali ZS, Flanders TM, Ozturk AK, et al. Enhanced recovery after elective spinal and peripheral nerve surgery: pilot study from a single institution. J Neurosurg Spine. 2019:1-9.
Injections reduce headache frequency
Is botulinum toxin effective for reducing the frequency of migraine headaches? To find out, researchers conducted a meta-analysis of randomized, double-blind, placebo-controlled trials that compared patients receiving botulinum toxin injections versus placebo injections in head and neck muscles for migraine prevention. The primary outcome was a change in the number of headache episodes per month from baseline to 3 months.
The results, based on 17 studies including 3,646 patients, showed a significant reduction in the frequency of migraine at both 2 and 3 months. “This meta-analysis reveals that botulinum toxin type A injections are superior to placebo for chronic migraines after 3 months of therapy,” the authors write. “For the first time, a real benefit in patient quality of life is demonstrated with only few and mild adverse events.”
Source: Bruloy E, Sinna R, Grolleau JL, Bout-Roumazeilles A, Berard E, Chaput B. Botulinum toxin versus placebo: a meta-analysis of prophylactic treatment for migraine. Plast Reconstr Surg. 2019;143(1):239-250.