Comment on: Treatment efficacy and safety of adalimumab versus tocilizumab in patients with active and severe Takayasu arteritis. Reply

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Dear Editor, Thanks to Durga for his comments and suggestions on this paper [1]. Currently, glucocorticoid (GC) tapering is still challenging in patients with Takayasu arteritis (TAK). According to the EULAR guidelines, a GC dose of ≤10 mg/day was suggested after 1 year [2]. Considering the disease of the patients included in this study was active and severe, the GC target dose for 6 months was set at 15 mg/day. We totally agree with Durga’s comments that 6 months was too short to assess angiographic progression. Since this study was conducted during the COVID-19 pandemic, a long-term follow-up was unfortunately interrupted. Hence, subsequent randomized controlled trials (RCTs) with larger sample sizes and longer follow-ups are warranted. In this study, a mixed randomization method was used [3]. Briefly, mixed randomization is a randomization procedure merged with the commonly used method of permuted block randomization (the block size changed randomly) by randomly inserting small segments of simple random sequences, making random sequences more unpredictable. The independent statistician generated the randomization lists using SAS 9.4. The allocation concealment was the use of sequentially numbered, opaque, sealed envelopes. The researchers opened the envelopes according to the order of patient enrolment. As commented on by Durga, the two study groups had imbalances at baseline, especially with respect to disease duration and the treatment:treatment-naïve patient ratio. To off-set this, we tried to re-analyse the data through propensity score matching, but the sample size was too limited. Thus, stratified analyses were conducted based on these two confounding factors. Regarding the treatment-naïve/treatment-refractory factor, the results were analysed separately for treatment-naïve and treatment-refractory patients. Among the treatment-refractory patients, the results indicated that patients in the adalimumab (ADA) group had a relatively higher efficacy rate (ER) or complete remission (CR) compared with those in the tocilizumab (TCZ) group (Table 1). However, due to the limited number of treatment-naïve patients in the TCZ group (n = 2), comparison analysis could not be performed for this subgroup. Regarding disease duration, the patients were stratified into patients with a long disease duration (≥5 years) and patients with a short disease duration (<5 years). The Cochran–Mantel–Haenszel test was then performed by controlling this parameter. The results didn’t indicate that the disease duration affected the final results (Supplementary Table S1, available at Rheumatology online). Evaluation of treatment efficacy of treatment-refractory patients in the TCZ and ADA groups after 6 months of follow-up ADA: adalimumab; TCZ: tocilizumab; CR: complete remission; ER: effectiveness rate; RR: risk ratio. Evaluation of treatment efficacy of treatment-refractory patients in the TCZ and ADA groups after 6 months of follow-up ADA: adalimumab; TCZ: tocilizumab; CR: complete remission; ER: effectiveness rate; RR: risk ratio. We also concur with Durga's suggestion about the risk ratios. According to his suggestion, we calculated the OR with a 95% CI of efficacy, which is 1.629 (1.027, 2.582). Regarding Durga’s comments about the discrepancies in the protocol in the paper and at the clinicaltrials.gov website, we checked the website and found that we had forgotten to update the specific information in the frames after uploading the revised study protocol document on clinicaltrials.gov. We will take care of this in future studies to maintain consistency. Supplementary material is available at Rheumatology online. The data underlying this article will be shared on reasonable request to the corresponding author. No specific funding was received from any bodies in the public, commercial or not-for-profit sectors to carry out the work described in this article. Disclosure statement: The authors have declared no conflicts of interest.

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