1. General Considerations

   1. In general, autoimmune skin diseases should be considered lifelong, but they can undergo remission and be controlled with appropriate therapy.
   2. Although monotherapy may be successful, multimodal therapy is often required in more severe or refractory cases.
   3. Baseline and regular laboratory tests are recommended for adverse event monitoring for most drugs.
   4. Client education is a very important aspect of the treatment plan. Clients need to be aware of the need for frequent recheck visits to monitor efficacy and adverse effects and that it may take a long time to establish the proper maintenance therapy.

2. Medications and Treatment Protocols

   1. Sunscreens:
      1. Waterproof SPF 15 or higher.
      2. Use on sun-exposed skin in facial discoid lupus erythematosus, generalized discoid lupus erythematosus, exfoliative cutaneous lupus erythematosus, vesicular cutaneous lupus erythematosus, systemic lupus erythematosus, and pemphigus erythematous.

1. 2. Vitamin E:
      1. Only use vitamin E as adjunctive therapy since it will not work well as sole therapy.
      2. It is antioxidant, stabilizes lysosomes, and is antagonistic to leukotriene formation.
      3. Its onset of action is 6 to 12 weeks post treatment initiation.
      4. It may be used for any of the autoimmune dermatoses listed here.
      5. Dose: 400 to 800 IU twice daily.

1. 3. Tetracyclines (tetracycline, doxycycline or minocycline) and niacinamide therapy:
      1. Their mechanism of action is not completely known; however, they inhibit  neutrophil chemotaxis and release of proteases.
      2. Onset of action – They have a lag phase of 1 to 2 months.
      3. Indications – Most effective in facial discoid lupus erythematosus but tetracyclines and niacinamide may be tried in any autoimmune dermatoses.
      4. Recently reported to be effective in one case of canine generalized cutaneous lupus erythematosus.
      5. Try it in mild cases of autoimmune skin diseases or as adjunctive therapy in severe cases of any of the listed autoimmune dermatoses to reduce the dosage of immunosuppressive/immunomodulatory drugs such as glucocorticoids, azathioprine, and cyclosporine.
      6. Because of the risk for bacteria developing resistance to tetracyclines, especially doxycycline, we are trying to avoid this treatment modality to treat autoimmune or immunomediated skin diseases.
      7. Dose:
         1. Tetracycline:
            1. < 10 kg body weight: 250 mg of each drug q 8hrs.
            2. 10 kg body weight: 500 mg of each drug q 8hrs.
         2. Doxycycline:
            1. 5 mg/kg q 12hrs.
         3. Minocycline:
            1. 12.5 – 25 mg/kg q 12hrs.
      8. Niacinamide (not niacin) – It should be used concurrently with a tetracycline.
      9. Side effects of the drug combination are uncommon and include anorexia, vomiting, diarrhea, lethargy, increased liver enzymes, and increased seizure activities.

1. 4. Corticosteroids:
      1. Topical – Always consider topical steroids for focal lesions or as adjunctive therapy, as a measure to prolong the interval between systemic therapies: 0.1% mometasone furoate ointment (Mometamax®), 0.01% fluocinolone acetonide (Synotic®), 0.015% triamcinolone solution (Genesis Spray®), 0.0584% hydrocortisone aceponate (Cortavance®). Fluorinated steroids in occlusive bases are more potent.  Application frequency starts at 1-2 times daily for 7-14 days, then tapered to the lowest effective dose, ideally for a short period. Use it carefully! Topical glucocorticoids can cause cutaneous atrophy and induce iatrogenic Cushing’s syndrome.
      2. Oral – Prednisone or prednisolone (dogs: 2 to 6 mg/kg/day; cats: 4 to 6 mg/kg/day) once daily or divided into twice daily administration until disease is in remission (recheck in 2 weeks). Remember! Use prednisolone in cats because they do not convert effectively prednisone into prednisolone.
         1. Gradually decrease the dose and give it on alternate days. Reducing the dose from daily to every-other-day may precipitate a relapse. In this case, consider adding another immunosuppressive/immunomodulatory drug such as azathioprine or chlorambucil (dogs) or chlorambucil (cats), or mycophenolate mofetil.
         2. Goal: 0.5 to 1 mg/kg PO every-other-day or ideally less than this.
         3. Cats may require twice the dog dose (Goal: 1-2 mg/kg every-other-day or ideally less than this).
      3. If prednisone or prednisolone is not effective, try dexamethasone at the dose of 0.1 to 0.2 mg/kg q 12hrs. until the disease is in remission then gradually decrease the dose to 0.5 to 0.1 mg/kg every 48 to 72 hrs. A retrospective study reported that oral triamcinolone given at the dosage range of 1.0 to 2.0 mg/kg was more effective to treat pemphigus foliaceus in cats and had less side effects than prednisolone alone or in combination with chlorambucil. Cats were maintained at the dosage range of 0.6 to 1.0 mg/kg every 2 to 7 days.
      4. Approximately 50% of the cases respond to oral glucocorticoids as the sole therapy.
      5. If oral prednisone/prednisolone, triamcinolone, or dexamethasone does not work satisfactorily, add another immunosuppressive drug to the treatment regimen.
      6. Repositol injections of glucocorticoids are not usually effective and are associated with more severe side effects. Avoid them!
      7. Mechanism of action of glucocorticoids:
         1. Inhibit chemotaxis of neutrophils, eosinophils, and lymphocytes.
         2. Inhibit T-lymphocytes function.
         3. Stabilize lysosomal membranes.
         4. Decrease antibody response.
         5. Inhibit prostaglandin production and release.
      8. Side effects:
         1. Iatrogenic Cushing’s syndrome including polydipsia, polyuria, polyphagia, muscle wasting, distended abdomen, increased infections, demodicosis, alopecia, elevated alkaline phosphatase, alanine transaminase, and stress leukogram.
         2. Cats are prone to develop diabetes mellitus, which is the most concerning side effect. However, they can also develop iatrogenic Cushing’s disease.
         3. If glucocorticoids are used as the sole therapy, semi-yearly to yearly CBCs, chemistry profiles, urinalysis, and urine cultures should be performed to monitor for common side effects.

1. 5. Non-steroidal Immunosuppressive/Immunomodulatory Drugs:
      1. These drugs are usually given with glucocorticoids so that a lower dose of glucocorticoids can be used to control the disease. You can start therapy with a combination of glucocorticoids and cytotoxic drugs or add a cytotoxic drug if the disease cannot be controlled or maintained on glucocorticoids alone. They may also be used when glucocorticoids are not well tolerated or are contraindicated.

1. 1. 2. Tacrolimus (Protopic® 0.03% – 0.1% ointment) and Pimecrolimus (Elidel® cream)- They are calcineurin inhibitors. Their mechanism of action is similar to cyclosporine. They may be used alone or in combination with systemic therapy as sparing agents. Tacrolimus has been shown to be successful in the teratment of facial discoid lupus erythematosus cases. Apply it initially at least 2 times daily.  After clinical signs have resolved or improved significantly, reduce the frequency to the lowest one that keeps the condition under control.
      3. Modified cyclosporine (Atopica® or Neoral®) – Cyclosporine is a calcineurin inhibitor. It may be used at the dosage of 5 mg/kg, orally, q 24 hrs. to manage the lupus diseases including facial discoid lupus erythematosus, exfoliative lupus erythematosus, and vesicular lupus erythematosus but it is not typically effective for the pemphigus complex, particularly in dogs. However, it may be used at higher doses (7-10 mg/kg/day) or in conjunction with glucocorticoids and/or azathioprine or another immunomodulatory drug to treat refractory cases of pemphigus foliaceus in dogs (monitor closely for secondary severe infections if using cyclosporine combined with other immunosuppressive drugs). The maintenance dosage can be reduced to every-other-day or the lowest effective dosage. Vomiting is the most common side effect. Other side effects include gingival hyperplasia, papilloma-virus induced lesions, muscle tremors, and hyperthricosis. Long-term side effects are unknown at this time. To reduce cost, cyclosporine can be used concurrently with ketoconazole (2.5 to 5-mg/kg/day) because ketoconazole inhibits the P-450 enzyme that metabolizes cyclosporine. Therefore, when used concurrently the dose of cyclosporine is reduced to half.
         1. Cyclosporine at the median dose of 5.25 mg/kg/day was as effective as chlorambucil to treat cats with pemphigus foliaceus. The median time to remission was 36.5 days.
      4. Azathioprine (Imuran®) – It is a purine analogue and is transformed into 6-mercaptopurine, which interferes with DNA and RNA synthesis by inhibiting enzymes needed for purine synthesis. Azathioprine inhibits T and B lymphocyte function.
         1. Azathioprine can be added to the treatment regimen if glucocorticoid alone is not effective. Another option is to initiate the treatment regimen with a combination of glucocorticoids and azathioprine. Azathioprine is often used to treat canine pemphigus foliaceus and other forms of pemphigus.
         2. Dose: 1.5 to 2.5 mg/kg/day until remission; then reduce the frequency to alternate day.
         3. Onset of action: 4 to 6 weeks.
         4. Side effects:
            1. Bone marrow suppression (monitor with CBC).
            2. GI upset.
            3. Hepatotoxicity (can be fatal).
            4. Opportunistic infections, demodicosis, neoplasia.
            5. DO NOT USE AZATHIOPRINE IN CATS because cats are prone to develop profound leukopenia and thrombocytopenia.
            6. Initially a CBC, platelet count, and hepatic profile should be performed every 1 to 2 weeks for the first 12 weeks. Once the CBC is stabilized, the frequency of monitoring can be decreased to every 2 to 3 months. Periodic chemistry screens (monthly) should also be performed, since some cases can develop a hepatotoxicity associated with just straight azathioprine.

1. 1. 5. Chlorambucil (Leukeran®) – It is an alkylating agent and crosslinks DNA.
         1. Dose: 0.1 to 0.2 mg/kg q 24 to 48 hrs.
         2. Onset of action: 3 to 6 weeks.
         3. Safe and effective in cats.
         4. It may be useful in very small dogs because it is easy to dose (i.e. comes in 2 mg tablets).
         5. Side effects:
            1. Minimal. May cause bone marrow suppression with long-term use.
            2. Monitoring is similar to that of azathioprine.

1. 1. 6. Mycophenolate mofetil:
         1. Mycophenolate mofetil (MM) (Cellcept®, Myfortic®) is an immunosuppressive drug that inhibits the enzyme inosine monophosphate dehydrogenase suppressing T lymphocyte and B lymphocyte proliferation and antibody production.
         2. Indications – There is limited information about the safety and efficacy of MM in veterinary medicine; however, there is potential for its use in the treatment of pemphigus diseases and other autoimmune dermatoses in dogs. There is only one study reporting the efficacy of MM to treat pemphigus foliaceus in dogs. The dogs in this study had a success rate of 50%, with most patients requiring concurrent glucocorticoid therapy to control the disease. A German shorthaired pointer dog with exfoliative cutaneous lupus showed excellent response to MM given at 22 mg/kg twice daily. Marked improvement was noted in 3 weeks and after 4 months of therapy, the lesions resolved. The dog was maintained in remission at the dose of 10 mg/kg twice daily.
         3. It is potentially useful in cats, but there is little information available regarding its safety profile and efficacy.
         4. Dose:
            1. 20-40 mg/kg/day divided q 8 hrs. on an empty stomach
         5. Side effects include gastrointestinal effects (i.e. anorexia, vomiting, diarrhea), lethargy, pyoderma, and Malassezia dermatitis. There is minimum risk for bone marrow suppression. Increased malignancy and infection rates are possible, especially with long-term use.
         6. Monitoring:
            1. Efficacy and adverse effects.
            2. CBC and chemistry profile should be done at baseline and periodically.

1. 6. Janus Kinase Inhibitor (JAK): Oclacitinib (Apoquel®)
      1. Oclacitinib is a non-selective JAK inhibitor, especially a JAK1. It blocks the JAK/STAT signaling pathway and by doing so it inhibits the activity of various inflammatory and immunomodulatory cytokines.
      2. It has shown to be effective in some dogs and cats to treat pemphigus foliaceus, pemphigus vulgaris, facial discoid lupus erythematosus, mucocutaneous lupus erythematosus, exfoliative lupus erythematosus, and cutaneous vesicular lupus erythematosus.
         1. Dose for cats: 1 mg/kg q 12h until remission, then 1 mg/kg q 24h as maintenance therapy. If no response is noted after 14 days of twice-daily therapy, discontinue treatment.
         2. Dose for dogs: 0.4 – 0.6 mg/kg q 12h until remission, then 0.4 – 0.6 mg/kg q 24h as maintenance therapy. If no significant improvement is noted during the twice-daily dosing, increase the dose to 1 mg/kg q 12h. If no improvement is noted after two weeks of therapy, discontinue treatment.
      3. Monitor closely for potential side effects.
         1. Mild increases in ALT, BUN, and creatinine, as well as anemia and leukopenia have been reported in cats treated with oclacitinib for the control of atopic skin syndrome. One cat developed severe anemia one week after starting therapy. However, this concerning side effect is not frequent but close monitoring is important. Dogs can also develop signs of bone marrow suppression and need to be monitored closely.
         2. The development of demodicosis or viral papillomatosis during treatment suggests immunosuppression and treatment discontinuation is recommended.
         3. The induction of cancer during treatment with oclacitinib is controversial. However, it is recommended to not prescribe this drug in animals with a history of cancer.
   7. Gold therapy – Gold salts reduce complement formation, epidermal enzymes formation, lysosomal enzymes, histamine and prostaglandin, and immunoglobulin formation.
      1. Drug – Injectable sodium aurothiomalate (Myochrysine®) or aurothioglucose (Solganol®).
      2. Onset of action: Gold salt has a lag phase of 6 to 12 weeks (gold salt levels slowly build up in the tissue to therapeutic concentrations).
      3. Therapeutic protocol:
         1. A test dose of 1 to 5 mg is administered intramuscularly at the first week and a test dose of 2 to 10 mg at the second week.
         2. If the animal tolerates the drug with no side effects then 1 to 1.5 mg/kg is given intramuscularly weekly until the disease is in remission.
         3. The dosage of 1.5 mg/kg is then given at the frequency required to keep the disease in remission. This is usually every 2 to 4 weeks.
      4. Gold salts have been shown to be effective to treat the pemphigus complex in dogs and cats.
      5. Side effects:
         1. In dogs, the side effects include thrombocytopenia, proteinuria, hepatic necrosis, muscle soreness, and toxic epidermal necrolysis.
         2. An increase in blood eosinophil count may indicate impending thrombocytopenia.
         3. If side effects develop, discontinue therapy. Therapy with Gold may be cautiously resumed at a lower dose or at decreased frequency when the side effects have disappeared.
         4. Platelet counts, CBC, and urinalysis should be performed every 2 weeks during the first 16 weeks of therapy.

1. 8. Dapsone:
      1. Dapsone (Avlosulfon®) is a sulfone drug with bacteriostatic and bactericidal activities. It also has anti-inflammatory properties by decreasing neutrophil chemotaxis, complement activation, antibody production, and lysosomal enzyme synthesis.
      2. Indications – It is recommended alone or as adjunctive therapy in refractory cases of pemphigus and subepidermal blistering skin diseases in dogs.
      3. Rarely dogs may become resistant to dapsone.
      4. Avoid its use in cats, as they are more likely to develop neurotoxicity and hemolytic anemia.
      5. Dose:
         1. Start at 1 mg/kg q 8hrs. then taper to the lowest effective dose once in remission.
      6. Side effects include anorexia, vomiting, diarrhea, hepatotoxicity, hemolytic anemia, thrombocytopenia, leukopenia, neutropenia, dose-dependent methemoglobinemia, neuropathies, photosensitivity, and cutaneous drug eruption. Severe side effects are rare; however, toxicity can be serious.
      7. Monitoring – CBC and chemistry profile are recommended every 2-4 weeks during induction, then ever 3-6 months thereafter, if indicated.

1. 9. Hydroxychloroquine sulfate:
      1. Hydroxychloroquine sulfate (HCQ) (Plaquenil®) is an aminoquinoline with antimalarial and immunomodulatory properties such as decrease of autoantigen and presentation to immune cells, neutrophil phagocytosis and superoxide production, chemotaxis, downregulation of the expression of pro-inflammatory cytokines and protection against ultraviolet light-induced cell damage and inflammation. It also has antiplatelet and antihyperlipidemic effects
      2. Indications – There is limited information about the safety and efficacy of HCQ in veterinary medicine, however; there is potential for its use in the treatment of variants of canine cutaneous lupus erythematosus. One report showed improvement of clinical signs of canine exfoliative cutaneous lupus erythematosus without achieving remission. However, another report demonstrated complete remission in a dog with generalized discoid lupus erythematosus. In this study, HCQ was used in combination with a short course of topical tacrolimus and sun avoidance.
      3. The use of HCQ has not been reported in cats.
      4. Dose:
         1. The best dose and frequency is not known.
         2. 5-10 mg/kg q 24 hrs. with food. Attempt to reduce the frequency to every other day upon clinical remission. Drug may need to be compounded for accurate dose.
      5. Side effects: Although it appears to be well tolerated based on the few case reports in dogs; the exact safety profile is not known. Adverse effects reported include gastrointestinal (i.e. anorexia, vomiting, diarrhea, nausea), ocular effects (i.e. retinal changes), myopathy, neuropathy, headache, dizziness, and rarely cardiovascular abnormalities.
      6. Monitoring:
         1. Efficacy and adverse effects.
         2. Regular eye exams and CBC and chemistry profile are recommended.
         3. Consider cardiac exams in dogs with pre-existing cardiac abnormalities.

1. 10. Human Intravenous Immunoglobulin (hIVIG)
       1. Human Intravenous Immunoglobulin (hIVIG) (Carimune®, Octagam®, Gammagard®) is a novel therapy prepared from human pooled plasma and contains primarily IgG with traces of IgM, IgA, CD4, CD8 and leukocyte antigen molecules. Transfusion of hIVIG has been shown to regulate immune dysfunction.
       2. Indications – There is limited information about the safety and efficacy of hIVIG in veterinary medicine. However, there is potential use for this immune therapy as a rescue treatment for various severe or unresponsive autoimmune or immune-mediated dermatoses in dogs and cats, in some cases leading to long-term remission. It has been used most commonly to treat canine immune-mediated hemolytic anemia and immune-mediated thrombocytopenia. A few anecdotal reports have indicated successful treatment for pemphigus foliaceus, epidermolysis bullosa acquisita, adverse cutaneous drug reactions, and drug-induced Steven’s Johnson syndrome in dogs and erythema multiforme in a cat.
       3. It may be cost prohibitive, particularly for large breeds of dogs.
       4. Dose:
          1. The optimal dose and frequency is not known.
          2. 0.5 – 2.2g/kg intravenously in 5 – 6% sterile saline solution infused over 4 – 12 hours is recommended. Serial transfusions may be needed.
          3. Discontinue other medications during the infusion period.
       5. Side effects – Although it appears to be well tolerated based on the few case reports in dogs, the exact safety profile is not known. Rare side effects include vomiting, induction of antihuman IgG autoantibodies or immune complex formation presented as acute hypersensitivity reaction.
       6. Monitoring:
          1. Efficacy and adverse effects during infusion.
          2. Signs of acute hypersensitivity warrant immediate cessation of the transfusion and antihistamine administration.
          3. The following tests are recommended at baseline and during infusion: CBC, chemistry profile, urinalysis, blood pressure, heart and respiratory rate, and temperature.

1. 11. Therapy Summary:
       1. Oral glucocorticoid is considered by many the first therapy choice to manage autoimmune dermatoses in dogs and cats.
       2. Glucocorticoids will work as the sole therapy in about 50% of the cases.
       3. If no significant response is noted after 10 to 14 days of glucocorticoid therapy and/or side effects are severe or the dose cannot be reduced, consider adding another immunosuppressive/immunomodulatory drug to the treatment regimen.
       4. Azathioprine or mycophenolate mofetil is a good second option for dogs.
       5. Oclacitinib can be effective to treat pemphigus foliaceus in dogs and cats and facial discoid lupus erythematosus and vesicular cutaneous lupus in dogs. Oclacitinib is currently not approved to treat autoimmune skin diseases in dogs and cats and it should be used when conventional treatments do not work or cannot be tolerated.
       6. Chlorambucil is a good second option for cats.
       7. Monitor for potential side effects during therapy.
       8. A tetracycline (i.e. tetracycline, doxycycline, minocycline) and niacinamide can be the sole therapy for mild cases of autoimmune dermatoses, especially facial discoid lupus erythematosus, and an adjunctive therapy for severe cases. However, try to avoid using an antibiotic to treat inflammatory skin diseases to prevent development of bacterial resistance to antibiotics.
       9. Topical glucocorticoids can be the sole therapy for mild cases of autoimmune dermatoses, including facial discoid lupus erythematosus, and an adjunctive therapy for severe cases. Be careful with iatrogenic Cushing’s disease, especially when treating a large body region for a long period.
       10. Tacrolimus (Protopic® 0.03 – 0.1% ointment) – It has been shown to be efficacious for the treatment of facial discoid lupus erythematosus and as an adjunctive therapy for vesicular cutaneous lupus erythematosus.
       11. Cyclosporine is effective to treat more severe cases of facial discoid lupus erythematosus and the generalized variant of discoid lupus erythematosus, but it has not been very effective for pemphigus complex, mostly in dogs.
       12. Protection from sun damage should be part of the therapy in lupus diseases and pemphigus erythematosus.
       13. Less conventional therapies with limited veterinary experience, including dapsone, hydroxychloroquine, and human IVIG antibodies may be used in selected refractory or severe cases.

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