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I. Einar, M.B. B.CH. B.A.O., Ph.D.

Assistant Professor, Wake Forest School of Medicine

Interstitial pneumonitis or clinically significant pulmonary fibrosis Myelodysplasia Pregnancy or planning pregnancy Renal impairment Significant drug interaction Appendix D: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate, Cyclosporine or Acitretin. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Previously treated follicular lymphoma, in combination with a rituximab product 6. Previously treated marginal zone lymphoma, in combination with a rituximab product B. High-grade B-cell lymphomas All other indications are considered experimental/investigational and are not medically necessary. Multiple myeloma Authorization of 12 months may be granted for treatment of multiple myeloma. Second-line or subsequent therapy of post-transplant lymphoproliferative disorder (non-germinal center B-cell type) 4. Histologic transformation of marginal zone lymphoma to diffuse large B-cell lymphoma after multiple lines of chemoimmunotherapy 6. Second-line or subsequent therapy for non-germinal center diffuse large B-cell lymphoma in non-candidates for transplant 7. Second-line or subsequent therapy for refractory or progressive nodal marginal zone lymphoma 13. Second-line or subsequent therapy for adult T-cell leukemia/lymphoma (acute or lymphoma subtypes) 17. Second-line or subsequent therapy for relapsed or refractory enteropathy-associated T-cell lymphoma 21. Second-line or subsequent therapy for relapsed or refractory monomorphic epitheliotropic intestinal T-cell lymphoma 22. Second-line or subsequent therapy for relapsed or refractory follicular T-cell lymphoma 24. Second-line or subsequent therapy for refractory hepatosplenic gamma-delta T-cell lymphoma 25. Myelofibrosis-associated anemia Authorization of 12 months may be granted for treatment of myelofibrosis-associated anemia when all of the following criteria are met: 3. The requested medication will be given as a single agent or in combination with prednisone. Systemic light chain amyloidosis Authorization of 12 months may be granted for treatment of systemic light chain amyloidosis in combination with dexamethasone. Classical Hodgkin lymphoma Authorization of 12 months may be granted for treatment of relapsed or refractory classical Hodgkin lymphoma as a single agent. Hematologic indications2,6-10 Authorization of 12 months may be granted for treatment of any of the following indications: 1. Immune checkpoint inhibitor-related toxicities3 Authorization of 3 months may be granted for treatment of immune checkpoint inhibitor-related toxicities. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Evidence-based guideline: Clinical evaluation and treatment of transverse myelitis: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neuromyelitis optica Authorization of 24 months may be granted for treatment of neuromyelitis optica. Idiopathic inflammatory myopathy Authorization of 24 months may be granted for treatment of refractory polymyositis or dermatomyositis. Pemphigus vulgaris Authorization of 24 months may be granted for treatment of moderate to severe pemphigus vulgaris.

Clearance of psoriasis in the target nail was achieved in about 50% patients by week 50 [85]. A recent small, open, prospective trial compared all three agents for the treatment of nail psoriasis. In addition, any active chronic infection such as tuberculosis or hepatitis B is a contraindication to therapy [87]. The possibility of increasing the risk of lymphoma is also debated in the literature [87]. Relative contraindications to therapy include heart failure, prior malignancies, and family or personal history of systemic lupus or multiple sclerosis [87]. Because it does not actually destroy the activated pathogenic T cells, the psoriasis can actually worsen upon cessation of the drug due to a sudden influx of T cells into the skin. Topical tazarotene impairs keratinocyte proliferation and inflammation, one of the mechanisms of onycholysis. All studies found the drug to be well tolerated; repeated use caused minimal irritation. Acitretin is the treatment of choice for pustular psoriasis but is less effective against plaque psoriasis [100]. There is one report of near total clearance of severe nail psoriasis with acitretin [101]. Another report compared low-dose, short-term cyclosporine with etretinate and found significant alleviation of nail involvement in both the groups [102]. Although these are impressive results, oral retinoids are not the best choice for isolated nail psoriasis given the systemic side effects of hyperlipidemia and hyperostosis, and the localized side effects of xerosis and periungual pyogenic granulomas [104]. One major limitation of both topical and systemic retinoids is that they are pregnancy category X. Oral or Topical Chemotherapy and Keratolytic Agents Cyclosporine is well established as an effective oral immunosuppressive agent for the treatment of generalized psoriasis as well as nail psoriasis [102,105]. Although highly effective, the systemic side effects make cyclosporine imperfect for long-term therapy or for isolated nail disease. Side effects include hypertension, renal insufficiency, increased risk of skin cancers, and elevated lipids. It is rarely used topically because it is a relatively large, highly lipophilic molecule that is unable to permeate the nail plate. Therefore, small hydrophilic molecules preferentially diffuse through the structure to the nail bed. Fluorouracil is a chemotherapeutic agent that inhibits the enzyme thymidylate synthetase, leading to a decrease in cellular proliferation. Using the low-dose formulation of the drug in a delayed nail penetration vehicle such as urea or propylene glycol enhances penetration [108]. Most studies have shown localized irritation with occlusive dressings as the most serious adverse effect. However, there is one report of transient rhabdomyolysis occurring after the use of topical 5-fluorouracil [109]. Because methotrexate is an immunosuppressive agent like cyclosporine, it is difficult to justify use of this agent for isolated nail psoriasis, except if there is severe impairment of digit function. However, in this report, the patient had previously been treated with acitretin for 12 months. Like most oral medications, the benefit of the drug for isolated nail psoriasis must outweigh the potential side effects. Topical anthralin is not usually a first-line medication due to the risk of long-term pigmentation of the nail plate. It has been used with moderate success for refractory nail psoriasis, with improvement in onycholysis, pachyonychia, and pitting [111]. In this study, anthralin was carefully washed away after 30 minutes of contact, followed by application of 10% triethanolamine to prevent pigmentation. For example, nail psoriasis is commonly misdiagnosed or diagnosis is delayed because it mimics other disorders. The most promising of all therapies are the newer biologic agents, such as infliximab.

Frequent and thorough patient assessments are indicated during the withdrawal period with particular attention to thoughts of self-harm. However, opiate detoxification can be completed safely in less than two weeks, and alcohol detoxification is a necessity for all inmates who present with alcohol dependence or withdrawal. If an inmate is placed in a locked unit or Special Housing Unit for detoxification, their medications, medical assessments, and ongoing monitoring must all be provided in a timely manner. All medications prescribed for the treatment of withdrawal should be administered via directly observed therapy at pill lines. Ideally, dosing should be three times a day or less, so as to accommodate pill lines at most institutions. Inmates presenting with alcohol intoxication should be presumed to have alcohol use disorder until proven otherwise. Despite the difficulty in obtaining an accurate history from an intoxicated inmate, a full assessment should be attempted. Individuals with a high blood alcohol level (>100 mg/dL) and concurrent signs of withdrawal are at particularly high risk for a severe withdrawal syndrome. Alcohol withdrawal symptoms can develop within a few hours of decreasing or discontinuing use. Early signs and symptoms of withdrawal include gastrointestinal distress, anxiety, irritability, increased blood pressure, and increased heart rate. Later, symptoms of moderate intensity develop, including insomnia, tremor, fever, anorexia, and diaphoresis. Withdrawal seizures can occur at various times during alcohol withdrawal, but generally begin within 48 hours of the last drink. If allowed to progress, delirium can result in changes in consciousness, marked autonomic instability, electrolyte imbalances, hallucinations, and death. With appropriate intensive treatment, mortality from delirium tremens is markedly reduced (to 1% or less). In many alcoholics, the severity of withdrawal symptoms increases after repeated withdrawal episodes. This is known as the kindling phenomenon, and suggests that even patients who experience only mild withdrawal should be treated aggressively to reduce the severity of withdrawal symptoms in subsequent episodes. Although performance of this test remains the function of Correctional Services, the results are medically relevant and should be ascertained and assessed by the clinician. Due to the potential dire consequences of non-compliance, oral doses should be administered at pill line. Patients actively seizing as a result of alcohol withdrawal, or showing signs of delirium tremens, should be immediately treated with benzodiazepines. Medication (lorazepam) is indicated to reduce symptoms and the risk of major complications. Strong consideration should be given to hospitalizing inmates who exhibit severe symptoms, as they are at increased risk for serious complications. This is in contrast to other benzodiazepines such as chlordiazepoxide, diazepam, and clonazepam, which are metabolized in the liver and can accumulate with slow metabolizers or with liver disease. For the most part, intramuscular administration should be avoided, due to variable drug absorption. A fixed-dose schedule is recommended for inmates with mild withdrawal who are being treated with lorazepam because they have either a history of alcohol withdrawal seizures or co-morbid cardiovascular conditions. For information about benzodiazepine dependence, see Section 7, Benzodiazepine Withdrawal. Thiamine replacement must be completed before administration of parenteral glucose. Hospitalization for inpatient detoxification and monitoring is strongly suggested. Lorazepam is administered according to the same schedule as described under "Moderate Withdrawal. Inmates with History of Alcohol Withdrawal Seizures Generally, inmates with a history of alcohol withdrawal seizures will present with signs and symptoms of moderate-tosevere withdrawal.

The features of erythema and scale may vary with changes in temperature and humidity and the use of emollients, instituting variables unrelated to an interventional therapy. This benchmark was established in a meeting between the Food and Drug Administration and the Dermatology Advisory Council in 1998. Subjective scoring of erythema, induration, and scale by a single trained observer has been demonstrated to be reliable compared to objective measures such as laser Doppler flowmeter, spectrodiometer, erythema meter, and chromameter (erythema); ultrasound (induration); and optical profilometry and scanning macrophoto- PsA Measures S69 4 if present in 4 quadrants. Characteristic nail changes involving the nail matrix include pitting, leuconychia, lunular red spots, and nail plate crumbling, whereas changes in the nail bed yield onycholysis and subungual hyperkeratosis, "oil-drop change," salmon spots, or splinter hemorrhages. This yields a potential total score of 80 if just the fingers are used and 160 if the toes are included. The original study describing the instrument showed good reproducibility (21) and a subsequent study showed good interrater reliability (30). Each nail is scored by the presence or absence of nail bed psoriasis and nail matrix psoriasis. Nail bed psoriasis includes onycholysis (separation of the nail bed), splinter hemorrhages (small, dark brown, linear marks under the nail), hyperkeratosis (thickened nail keratin), and oil-drop dyschromia (reddish-brown discoloration under the nail plate), while nail matrix psoriasis includes pitting (sharply defined depressions in the nail surface), leukonychia (white spots in the nail plate), crumbling, and red spots in the lunula. For nail bed psoriasis, if no nail bed features are present, a score of 0 is assigned. A score of 1 is assigned if nail bed features are present in 1 quadrant of the nail, 2 if present in 2 quadrants, 3 if present in 3 quadrants, and 4 if present in 4 quadrants. For nail matrix psoriasis, if no nail matrix features are present, a score of 0 is assigned. A score of 1 is assigned if nail matrix features are present in 1 quadrant of the nail, 2 if present in 2 quadrants, 3 if present in 3 quadrants, and Psychometric Information Acceptability. Excellent intraobserver agreement has been demonstrated among PsA patients, with an intraclass correlation coefficient of 0. For each fingernail, 7 groups of features are evaluated: pitting, onycholysis and oil-drop dyschromia, nail plate crumbling, leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula. Leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula are graded as either present or absent. Leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula are scored only by their presence or absence. A score of 1 indicates the presence of a feature, and a score of 0 indicates absence. Critical Appraisal of Overall Value to the Rheumatology Community this system does away with quadrant analysis and is simpler to perform, and is therefore more practical for clinical trials, and demonstrates excellent intra- and interrater reliability (31). Although classically depicted involving the Achilles tendon and plantar fascia insertion sites, enthesitis can involve many parts of the body, including periknee, pelvis, spine (vertebral ligament insertion), rib cage, shoulder, and elbow. Based on clinical experience, the investigators identified a large number of potentially involved enthesial sites.

The lesions themselves are usually papules that are purplish in colour, shiny and firm on palpation. A scarring alopecia can develop due to scalp involvement, so-called lichen planopilaris. In addition to the cutaneous eruption, patients may have involvement of the mouth and genital mucosae with sore erosions and ulceration. However, histological features seen on a skin biopsy can be helpful in distinguishing between lichen planus and lichenoid drug eruptions when a drug trigger is suspected. Most lichen planus settles within months to years and responds well to potent topical steroids, phototherapy or short courses of oral prednisolone. Orogenital involvement, however, may be more persistent and recalcitrant and may require prolonged systemic immunosuppressant therapy such as mycophenolate mofetil. She had been diagnosed with urticaria and been started on a regular antihistamine with no benefit. Two weeks ago she had attended her dental practitioner with painful oral erosions, and is awaiting specialist review. Her past medical history includes a cholecystectomy and borderline abnormal thyroid function tests, for which she is on no therapy currently. She has two small (5 mm) healing erosions on her right buccal mucosa and a fresh tense blister (~7 mm) on her hard palate. She has a symmetrical erythematous urticated eruption over the lateral aspects of her trunk, her submammary area, medial upper arms, and thighs and central back. Within these erythematous lesions there are multiple tense fluid-filled vesicles (5 mm) and bullae (5 mm). Normal Haemoglobin Mean corpuscular volume White cell count Platelets Differential white cell count Blood film: Urea and electrolytes Liver function tests 15. In addition to establishing a diagnosis and ruling out any underlying medical disorders, the priorities for this patient are pain relief and prevention of infection. Pain relief would include simple measures such as reducing friction to eroded areas of the skin (with easy-release dressings and/or greasy emollients) and minimizing activity, as well as pharmacological pain relief. Preventing infection can be challenging: barrier nursing and use of topical antiseptics such as potassium permanganate, triclosan and chlorhexidine, particularly when washing, are frequently advocated. The age of the patient, her history and presentation, and eosinophilia are highly suggestive of a diagnosis of bullous pemphigoid. Other autoimmune bullous diseases could be considered in the differential diagnosis, in particular: inflammatory epidermolysis bullosa acquisita (a mucous membrane pemphigoid, which often has a more insidious onset with more mucosal involvement than skin); erythema multiforme major (usually more haemorrhagic mucosal involvement and targetoid lesions); and bullous vasculitis (usually purpuric skin lesions in association with blistering, especially of the lower extremities). Occasionally bullous pemphigoid can be associated with underlying conditions such as inflammatory bowel disease or occult malignancy or be provoked by medication. Bullous pemphigoid is characterized by circulating and tissue-bound pathogenic anti-cutaneous basement membrane zone antibodies. Immunosuppression with systemic corticosteroids and steroid-sparing agents is the cornerstone of treatment; although for patients with milder or more localized disease superpotent topical corticosteroids alone may be sufficient to achieve disease control. Remission over a period of years is expected; however, prognosis is adversely affected in the elderly by their frequent co-morbidities. She has a 3-day history of a rapidly progressing, painful, erosive eruption affecting her upper trunk and intertriginous (groin and axillae) areas. Examination She has a widespread skin eruption over her trunk, within her axillae and groin, and involving the inner lips of her vulva. The individual lesions are erythematous and tender with overlying erosions, flaccid bullae and friable scale. There are similar erosions involving the mouth, particularly the lips and buccal mucosae. The presence of flaccid blisters on an inflammatory base affecting the skin and mucosa in this age group is most suggestive of a diagnosis of pemphigus vulgaris.