Safety And Efficacy Of Biologics In Patients With Psoriasis Combined With Hepatitis B Or Tuberculosis

Background:Psoriasis is a polygenic genetic disease mediated by immunity.The disease can occur at any age,but the incidence of young and middle-aged is higher than that of children and the elderly.The harm of psoriasis to patients is not limited to the skin.It also has many comorbidities,such as metabolic syndrome,cardiovascular disease,depression,anxiety and so on,which greatly threaten the physical and mental health of patients.With the discovery of TNF-α and IL-23/TH17 axis,the treatment of psoriasis has entered the era of biologics.China is a big country with hepatitis B and tuberculosis,so the safety of psoriasis patients with hepatitis B or tuberculosis using biologics is particularly important.This study is an open,controlled and retrospective clinical study.A total of547 patients with severe plaque psoriasis were collected.After passing the examination,they were given biologics（Adalimumab,Etanercept,Infliximab,Ustekinumab,Secukinumab,Ixekizumab,Guselkumab）according to the severity of skin lesions,willingness,and economic conditions of the patients.To evaluate the efficacy of biologics and the rate of activation of hepatitis B and tuberculosis in patients with psoriasis.Objective:To explore the efficacy of biologics and the safety of biologics in psoriasis patients with hepatitis B or tuberculosis.Methods:Patients with severe plaque psoriasis who visited the outpatient dermatology department of our hospital and agreed to use biologics from May 2019 to April 2021 were retrospectively collected according to the diagnostic criteria.Five markers of hepatitis B（HBs Ag,HBs Ab,HBe Ag,HBe Ab,HBc Ab）,HBV-DNA,T-SPOT.TB and chest CT were screened.According to the examination results,547 patients were divided into HBV carrier group,previous HBV infection group,psoriasis group with latent tuberculosis group,and without hepatitis or tuberculosis group.For patients with psoriasis and HBV carriers,liver function and HBV-DNA should be checked.Entecavir should be used 2 weeks in advance,and biologics and entecavir should be used at the same time 2 weeks later.In patients with psoriasis and previous HBV infection,the simultaneous use of biologics and entecavir continued until half a year after the end of biologics therapy.Patients with latent pulmonary tuberculosis took isoniazid,rifapentine and Hugan tablets orally for3 months while using biologics.Patients without hepatitis B or pulmonary tuberculosis do not receive preventive treatment.After that,all patients will be reviewed for liver function,five markers of hepatitis B,HBV-DNA,T-SPOT.TB and chest CT every 3-6 months.The activation rate of hepatitis B and tuberculosis was observed after 12 months.The patients with severe plaque psoriasis were evaluated for s PGA score and PASI score,and the patients in each group were given subcutaneous injection or intravenous drip of biologics.After that,s PGA score and PASI score were performed every 3 months,and the follow-up was 12 months.The patient’s skin lesions were observed.Special note: The above inspections and tests are completed by the Second Hospital of Jilin University or other hospitals.Results:No cases of hepatitis B virus reactivation were found in all patients after 12 months of follow-up.In addition,3 patients in the HBV carrier experimental group who were positive for HBV-DNA gradually turned negative during the treatment process.One patient was treated with adalimumab,and 2 patients were treated with secukinumab.Among 46 patients with latent tuberculosis in the adalimumab group,one patient developed tuberculous pleurisy after 6 months of treatment.There was also a T-SPOT.TB-negative patient with only a little calcification in the lungs.After 40 days of adalimumab treatment,the skin lesions completely subsided.Six months later,the patient suddenly developed fatigue,suspected miliary tuberculosis,and bilateral pleural effusion.The patient had never developed fever and cough,and was diagnosed with pulmonary tuberculosis by bronchoscopy.He is currently hospitalized in Changchun Tuberculosis Hospital.No cases of Mycobacterium tuberculosis activation were found in the remaining groups.Among 46 patients with latent TB in the adalimumab group,1 patient discontinued antituberculosis drugs after 82 days because alanine aminotransferase exceeded 3times the upper limit of normal.One patient with latent tuberculosis in the adalimumab group and one in the infliximab group had alanine aminotransferase levels between 2 and 3 times the upper limit of normal.There were 2 cases of latent tuberculosis patients in the 300 mg secukinumab group.The alanine aminotransferase levels of the remaining patients were less than 2 times,and the above patients all completed the use of anti-tuberculosis drugs for a full course of treatment.The skin lesions of the patients in each group were improved after receiving biologics,and the PASI and s PGA scores were significantly lower than before.Conclusion:1.In the process of using biologics to treat psoriasis,patients with hepatitis B can achieve the same safety as patients without HBV infection after receiving preventive anti-HBV treatment.2.In patients with slightly elevated HBV-DNA,biologics can still be used while adequate prophylactic antiviral therapy is given.In particular,IL-17 inhibitors such as secukinumab are safer.3.When using biologics to treat psoriasis,patients with latent pulmonary tuberculosis can effectively inhibit the reactivation of tuberculosis after receiving preventive anti-tuberculosis treatment.In this process,the combined use of liver-protecting drugs can reduce anti-tuberculosis Hepatotoxicity of the drug.4.Biologics have achieved good curative effect in the treatment of psoriasis.Ixekizumab and infliximab work faster.Guselkumab has a slower onset but better long-term efficacy.Etanercept is less effective than interleukin-based biologics,but can be used in pregnant women.People with body weight ≤ 60 kg were given 150 mg of secukinumab,which still achieved good curative effect.