Certolizumab effect in a cohort of 60 Libyan patients with rheumatic diseases

Abstract

Background: Tumour Necrosis Factor (TNF) has a central role in the pathogenesis of Rheumatoid Arthritis (RA), mediating both inflammation and joint damage. Certolizumab Pegol (CZP) is a PEGylated Fab fragment of a humanized anti-TNF antibody with high affinity to TNF.

Objective: The study was done to monitor the effects and side effects of certolizumab on our Libyan patients with rheumatic diseases.

Methods: The inclusion criteria for the study were all patients with rheumatic diseases who were treated by certolizumab in the period from August 2014 to August 2016 in Rheumatology Department, Tripoli Medical Center, Tripoli, Libya. They were 60 patients, 43 of them had RA, 14 patients had Ankylosing Spondylitis (AS), 2 patients had Psoriatic Arthropathy (PsA) and 1 patient had enteropathic arthritis. Certolizumab 400mg subcutaneous was given at week 0, 2, 4 and then 400mg every 4 weeks. Demographic details such as age and sex were recorded. Clinical characteristics as rheumatoid factor in RA patients, disease duration, duration of taking certolizumab and drugs used before starting certolizumab 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 starting certolizumab were requested to monitor its side effects during follow up.

Results: Forty three patients had rheumatoid arthritis, their mean age was 44.6±SD10.67 years, 11.6% were male and 88.3% were female. Rheumatoid factor was positive in 58%, negative in 19% and unknown in 23%. Fourteen patients were ankylosing spondylitis; their mean age was 34.9±SD8.22 years, 85.7% were male and 14.2% were female. Two patients had psoriatic arthritis, mean age was 43.5±SD16.26 years, one was female and the other was male. One patient had enteropathic arthritis; she was a female aged 57 years. All RA patients were on prednisolone and/or one or two DMARD before starting CZP and failed to show response. All AS patients were on one or two NSAIDs and/or salazopyrine and failed to show response before starting CZP. One psoriatic arthritis patient was on leflunomide and methotrexate (MTX) and the other was on MTX alone. Enteropathic arthritis patient was on MTX, azathioprine and salazopyrine. The mean of DAS28 before starting CZP for RA patients was 4.9+SD1.15 and the mean of DAS28 at the last dose was 3.1±SD1.12 (P value<0.0001). The mean of BASDAI before using CZP was 4.2±SD1.61 and the mean of BASDAI at the last dose was 1.7±SD1.86 (P value <0.0012). Both 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 <0.0002). Enteropathic arthritis patients showed significant improvement regarding gastrointestinal symptoms and arthritis. Regarding side effects of certolizumab pegol, one female RA patient developed tuberculus lymphadenitis and one male RA patient had hypersensitivity reaction.

Conclusion: During two years of follow up of our rheumatic diseased patients on certolizumab, we noticed a significant improvement in disease activity scores with minimal side effects.