Adalimumab effect in a cohort of Libyan patients with rheumatic diseases

Abstract

Background: Adalimumab is a recombinant human IgG1 monoclonal antibody. It is a tumour necrosis factorinhibiting, anti-inflammatory, biologic medication. It binds to tumour necrosis factor alpha (TNF), which normally binds to TNF receptor, leading to the inflammatory response of autoimmune disease. By binding to TNF, adalimumab reduces this inflammatory response.
Objective: The study was done to monitor the effects and side effects of adalimumab in our Libyan patients with rheumatic diseases.
Methods: The inclusion criteria for the study were all patients with rheumatic diseases who were treated with adalimumab in the period from April 2013 to April 2016 in the Rheumatology Department, Tripoli Medical Center, Tripoli, Libya. There were 31 patients, 10 of them had RA, 16 patients had Ankylosing Spondylitis (AS), 4 patients had Psoriatic Arthropathy (PsA) and 1 patient had Adult Onset Still’s Disease (AOSD). Adalimumab 40mg subcutaneous was given every 2 weeks. Demographic details such as age and sex were recorded. Clinical characteristics as rheumatoid factor in RA patients, disease duration, duration of taking adalimumab and drugs used before starting adalimumab were noted. Assessment of disease activity was measured by DAS28 for RA patients, by BASDAI for AS patients and by DAPsA for PsA patients. For all patients, complete blood count, erythrocyte sedimentation rate, liver function test, hepatitis screen, urine routine examination and tuberculin test before adalimumab were requested to monitor its side effects during follow up.
Results: All patients with rheumatic diseases who took adalimumab in the period between April 2013 and April 2016 were included in the study. Ten patients had rheumatoid arthritis, their mean age was 39.1 years, 10% were male and 90% were female. Rheumatoid factor was positive in 60%, negative in 30% and unknown in 10%. Sixteen patients were ankylosing spondylitis; their mean age was 39 years, 81.25% were male and 18.75% were female. Four patients had psoriatic arthritis, mean age was 40 years, two were females and two were males. One patient had AOSD; she was a female aged 58 years. All RA patients were on prednisolone and/or one or two DMARD before starting adalimumab and failed to show a response. Fourteen AS patients were on one or two NSAIDs and/or salazopyrine and failed to show a response before starting adalimumab and two patients were on infliximab which was not responding to it. Two psoriatic arthritis patients were on methotrexate (MTX) alone, two patients were on leflunomide alone. The AOSD patient was on MTX and prednisolone. The mean of DAS28 before starting adalimumab for RA patients was 4.06 and the mean of DAS28 at the last dose was 2.7 (P-value =0.0135). The mean of BASDAI before using adalimumab was 5.13 and the mean of BASDAI at the last dose was 1.656 (P-value <0.0001). PsA patients had moderate disease activity (mean of DAPsA=20+SD1.6) and became (mean of DAPsA=6+SD1.2) which means low disease activity (P-value <0.02). The AOSD patient showed significant improvement clinically and ESR dropped from 53 at the start to 12 at the last dose.
Conclusion: During three years of follow up of our rheumatic diseased patients on adalimumab, we noticed a significant improvement in disease activity scores with minimal side effects.