Immunobiological Therapy in Moderate-to-Severe Psoriasis: A Retrospective Cohort Study Investigating the Effects of Inadequate Therapeutic Compliance on Drug Survival

Abstract

Introduction

Evaluating psoriasis care in Brazil, a country characterized by its vast geographical expanse, may provide valuable lessons for healthcare systems globally. National research has revealed that individuals receiving biologic treatments in Brazil exhibit lower drug survival rates than individuals from other countries, highlighting challenges that may be applicable elsewhere. The aim of this study was to determine whether distribution problems, poor adherence, and improper storage of immunobiological therapeutics are significant risk factors for reduced drug survival during psoriasis treatment.

Methods

In this retrospective cohort study, patients diagnosed with psoriasis who were receiving immunobiological therapy were enrolled in a real-world registry. Drug distribution, adherence, and storage problems were evaluated as risk factors. The primary endpoint was drug survival. Relative risk (RR) and Kaplan‒Meier analyses were used to assess associations, and multivariable analysis was performed via accelerated failure time modeling.

Results

Among 166 patients, 82 (49.40%) discontinued treatment. Adalimumab was the most frequently administered biologic (n = 77), followed by secukinumab (n = 40), risankizumab (n = 9), guselkumab (n = 8), infliximab (n = 6), etanercept (n = 4), and ustekinumab (n = 19). Bimekizumab, brodalumab, and certolizumab pegol were each used by one patient. Distribution problems increased the risk of treatment interruption (RR = 1.45, 95% confidence interval [CI]: 1.07–1.95). After adjustment, the adverse impact of distribution problems diminished, most likely because of adalimumab’s more frequent dosing schedule. Adalimumab use was linked to shorter drug survival (hazard ratio = 1.51, 95% CI: 1.01–2.27). Postinjection management also raised concerns: 22.23% of patients reported disposing of biologic waste in the regular trash.

Conclusions

In settings marked by significant stress within the distribution, storage, and administration chains for immunobiologics, distribution problems appear to negatively affect drug survival. The use of therapies with longer dosing intervals or oral medications may help overcome these barriers.

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1007/s13555-026-01845-4.

Plain Language Summary

This study examined how people in Brazil with psoriasis, a long-term skin condition, receive important medicines called immunobiological therapies. Brazil is a very large country, which sometimes makes it difficult for patients to get their medication, maintain their treatment, or store the medicines properly. The researchers investigated whether these difficulties led to patients stopping their treatment earlier than expected. They followed 166 patients who were taking these medicines and found that nearly half of them (49.40%) stopped their treatment. Problems with getting the medicine delivered were linked to patients interrupting their treatment. However, this effect was lessened for those using adalimumab, a drug that needs to be taken more often. The study suggests that issues with distribution can make it more difficult for people to adhere to their psoriasis treatment. Using medicines that are taken less frequently, or oral medicines, could help people overcome these difficulties and continue their therapy for longer. This research highlights the importance of ensuring medicines are easy to access and use, especially in countries with large distances between patients and healthcare services.

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1007/s13555-026-01845-4.

Key Summary Points

Why carry out this study?

While both controlled clinical trials and real-world studies have consistently demonstrated high drug survival rates in the treatment of psoriasis, the long-term effects of injectable biologics are often influenced by complexities associated with their administration.

This study aimed to determine whether distribution problems, poor adherence, and improper storage of immunobiological therapeutics are significant risk factors for reduced drug survival during psoriasis treatment.

What was learned from the study?

Adalimumab was the most frequently administered biologic, followed by secukinumab, risankizumab, guselkumab, infliximab, etanercept, and ustekinumab.

Although distribution problems were associated with increased treatment interruptions, this effect was most pronounced with adalimumab, probably because of its frequent dosing schedule.

Introduction

Psoriasis is a chronic, noncommunicable skin disorder that affects approximately 2–3% of the global population [1]. Owing to Brazil’s vast size and its significant regional disparities, the country’s highly centralized procurement of immunobiologics for psoriasis treatment could serve as an instructive logistical and economic model for other countries. The largest country in South America, Brazil, operates the Unified Health System (SUS), which serves more than 200 million people [2, 3] and provides both public and private healthcare services [4].

Since 2020, patients with moderate-to-severe psoriasis have gained access to four immunobiological agents through the SUS: adalimumab (as first-line biologic therapy) and ustekinumab, secukinumab, and risankizumab (as second-line options) [2]. However, compared with international standards, lower drug survival rates have been reported in individuals using these therapies according to national studies [5, 6]. Additional biologic agents are available to the approximately 25% of Brazilians who are covered by private health insurance [2]. While decentralized locally, the SUS maintains a centralized distribution of high-cost medications, thereby reducing purchase-related costs and supporting economic sustainability. However, this centralization may hinder pharmacovigilance [7].

The primary aim of this study was to evaluate whether distribution problems, poor adherence, and inadequate storage of immunobiological therapeutics constitute significant risk factors for reduced drug survival in the treatment of moderate-to-severe psoriasis. This study also aimed to perform exploratory analyses to determine the specific factors that contribute to the discontinuation of immunobiological therapies.

Methods

Study Design and Population

This retrospective cohort study included adult patients with a diagnosis of severe plaque psoriasis, as defined by a Psoriasis Area Severity Index (PASI) > 10, a body surface area (BSA) > 10, or a Dermatology Life Quality Index (DLQI) > 10 at any point in the patient’s history. Eligible participants initiated immunobiological therapy prior to May 2025 and were enrolled in an ongoing real-world registry for institutional follow-up. The registry includes a comprehensive questionnaire that is designed to evaluate the occurrence of distribution problems, poor adherence, and inadequate storage of immunobiological therapeutics.

Exclusion Criteria

We excluded patients who participated in or were planning to participate in an interventional clinical trial involving a nonmarketed or marketed investigational drug.

Data Source/Data Collection Process

The data used in this study were obtained from a longitudinal registry titled “Autoimmune Diseases in Real Life in Brazil: a Multicenter Cohort Study Based on the Evaluation of Clinical and Molecular Epidemiology"; registry no./approval no. CAAE: 68,068,323.3.1001.5558. The registry received approval from the Research Ethics Committee of the Faculty of Medicine of the University of Brasília, Brazil. All patients signed informed consent forms.

Definitions of Study Variables

Primary Endpoint

The primary endpoint was defined as drug survival (the length of time in months) from the initiation of a biologic until its discontinuation (treatment interruption or switch to another biologic).

Secondary Endpoints

Secondary endpoints included a PASI > 10, a BSA > 10, a DLQI > 10, the occurrence of any severe adverse events that led to discontinuation of treatment, the occurrence of any infection, and the occurrence of any major adverse cardiac events (MACEs).

Main Risk Factors (Exposure/Independent Variables of Interest)

Three primary variables were identified as the main risk factors in this study: problems with distribution of the biologic (distribution problems), poor biologic adherence (poor adherence), and inadequate storage of the biologic (inadequate storage). These factors were defined on the basis of patient responses in the registry as follows: (1) distribution problems: the patients were asked whether they had experienced any delays in medication delivery (yes/no); (2) poor adherence: the patients were asked whether they administered their biologic therapy on the exact dates prescribed by their physician (yes/no); and (3) inadequate storage: the patients were asked whether they stored their biologic medication exactly as directed in the package insert (yes/no). Additional registry questions are provided in Supplementary File S1. In addition to the demographic and clinical variables, patients were also categorized according to their method of access to immunobiological therapy: either exclusively through the public health system or through health insurance providers. All data generated or analyzed during this study are included in this published article (Supplementary File S2).

Statistical Analysis

Unadjusted relative risks (RRs) and Kaplan‒Meier survival analyses were used to examine the associations of these factors with outcomes. Multivariable modeling was performed, with clinically relevant variables selected for a hierarchical model (blocks 1–3: demographics/clinical (age, sex, and initial PASI score), therapeutic (type of biologic used), and main risk factors). We applied an accelerated failure time (AFT) model, a parametric approach that assumes that covariates accelerate or decelerate survival time [8]. This approach provides valid estimates when the proportional hazards assumption is violated. Variables with p < 0.10 were included for adjustment; significance was set at p < 0.05. The survival and survminer packages in R (version 4.4.2, Posit Team, Boston, MA, USA) were used for analyses.

Power/Sample Size

Reported drug survival rates vary widely [9–13]. Aiming to adopt a conservative estimate, the authors assumed that 25% of patients with good adherence would discontinue therapy within 5 years, while 50% of those with poor adherence would stop treatment during the same period. To achieve 95% confidence and 80% statistical power in the results, at least 66 patients per group (discontinued biologic therapy versus ongoing biologic therapy) are needed. The sample size was increased by 20% to account for potential attrition.

Results

A total of 166 patients were included in the study. Regarding the primary outcome, 82 patients (49.40%) experienced treatment interruption. Among these, 73 patients (89.02%) experienced disease relapse, defined as a PASI > 10, a BSA > 10, or a DLQI greater than 10, while 15 patients (18.29%) reported adverse events. Six patients (7.32%) experienced both disease relapse and adverse events at the time of interruption of biologic therapy. Adalimumab was the most frequently administered biologic (n = 77), followed by secukinumab (n = 40), risankizumab (n = 9), guselkumab (n = 8), infliximab (n = 6), etanercept (n = 4), and ustekinumab (n = 19). Bimekizumab, brodalumab, and certolizumab pegol were each used by one patient. The median time to relapse in months for each biologic used is presented in Supplementary Table S1 (Supplementary File S1).

Among the covariates that could influence the three main domains related to inadequate therapeutic compliance, several notable findings were identified. A total of 64 patients (38.55%) reported experiencing biologic distribution problems. Distribution problems were reported by 59 (40.69%) of the 145 patients who performed home infusions, as well as by 5 (23.81%) of the 21 patients who received their immunobiologic therapy at a clinic or hospital; the latter group exclusively included individuals who were covered by private health insurance (p = 0.213). In addition, 63 patients (37.95%) reported having experienced delays in the delivery or administration of the biologic relative to the schedule prescribed in the product insert. Collectively, 57 patients (34.34%) stated that their biologic medication was out of stock at some point during their treatment. Furthermore, eight patients (4.82%) indicated that a biosimilar had been substituted for the reference biologic without prior notification from the prescribing physician.

Poor adherence that effectively interfered with medication administration was identified in 14 patients. However, 21 patients (12.65%) reported feeling extremely uncomfortable with injectable medications and would prefer oral alternatives if available. In addition, nine patients (5.43%) reported injection-related phobia, characterized by symptoms such as dizziness, vomiting, fainting, and an overwhelming sense of fear prior to administration of the immunobiologic. Finally, regarding inadequate storage, 21 patients did not store their medications exactly as recommended in the product insert. In addition, 37 patients (22.29%) reported improper disposal of used syringes or pens, stating that they discarded them in the regular household waste either because of a lack of proper guidance or because they did not have appropriate disposal containers at home.

Drug Survival

The mean follow-up time for the selected patient cohort was 30.66 months (133 weeks; standard deviation = 33.41; range: 1–186 months). Univariable analysis revealed a significant overall association between distribution problems and an increased risk of treatment interruption (RR = 1.45, 95% confidence interval [CI]: 1.07–1.95; p = 0.028) (Table 1) (Fig. 1). Comparative survival curves for patients who were and were not receiving adalimumab are shown in Fig. 2. Multivariable modeling indicated that the interval before treatment interruption was shortest among adalimumab users (hazard ratio [HR] = 1.51; 95% CI: 1.01–2.27; p = 0.044) (Table 1). However, the effect of distribution problems on immunobiological therapies did not reach statistical significance in the AFT model, which evaluates whether covariates accelerate or decelerate survival time. The Kaplan–Meier survival curves revealed that the increased risk linked to distribution problems was most significant during the intermediate follow-up period and that this hazard leveled out over time (Fig. 1). This finding indicates that there was a time-dependent effect in which distribution issues mainly increase the risk of interruption of intermediate-term treatment.

Table 1.

Analysis of the associations of risk factors for reduced drug survival using both unadjusted and adjusted analytical approaches

	Treatment interruption				AFT–HR (95% CI) p value
	Yes (n = 82)	No (n = 84)	RR (95% CI) p value	Log-rank p value
Sex
Female	42 (51.22%)	37 (44.05%)	1.16 (0.85–1.57) 0.442	0.200	–
Male	40 (48.78%)	47 (55.95%)
Age*—mean (standard deviation)	51.08 (13.11)	49.74 (13.38)	1.16 (0.83–1.61) 0.513	0.810	–
Smoking habit	10 (12.20%)	13 (15.48%)	0.86 (0.53–1.41) 0.699	0.570	–
Alcohol abuse	6 (7.32%)	6 (7.14%)	1.01 (0.56–1.82) 1.000	0.310	–
Initial PASI > 10	45 (54.88%)	41 (48.81%)	1.13 (0.83–1.54) 0.531	0.300	–
Initial DLQI > 10	65 (79.26%)	63 (75.00%)	1.14 (0.77–1.68) 0.639	0.110	–
Plaque psoriasis	77 (93.90%)	80 (95.24%)	0.88 (0.48–1.62) 0.745	0.400	–
Psoriatic arthritis	36 (43.90%)	32 (38.10%)	1.10 (0.81–1.50) 0.634	0.650	–
Biologic type			0.423	–	–
Adalimumab	44 (53.66%)	33 (39.29%)	1.34 (0.98–1.82) 0.429	0.059	1.51 (1.01–2.27) 0.044
Bionaive patients	53 (64.63%)	45 (53.57%)	1.27 (0.91–1.76) 0.197	0.820	–
Home application	73 (89.02%)	72 (85.71%)	1.17 (0.70–1.98) 0.683	0.690	–
Distribution problems	39 (47.56%)	25 (29.76%)	1.45 (1.07–1.95) 0.028	0.640	0.82 (0.55–1.21) 0.324
Poor adherence	10 (12.20%)	4 (4.76%)	1.51 (1.04–2.19) 0.099	0.120	1.54 (0.84–2.82) 0.161
Inadequate storage	13 (15.85%)	8 (9.52%)	1.30 (0.89–1.90) 0.321	0.460	–

n number of patients, RR relative risk, 95% CI 95% confidence interval, AFT–HR hazard ratio estimated using an accelerated failure time (AFT) model, PASI  Psoriasis Area Severity Index, ^* relative risk was estimated by stratifying patients as > 60 years old or not, DLQI Dermatology Life Quality Index

Fig. 1.

Kaplan–Meier survival curves showing drug survival stratified by the presence or absence of distribution problems. The x-axis represents time in months, and the y-axis represents the probability of drug survival. Patients with distribution problems (“yes”) are compared with those without distribution problems (“no”). The p value corresponds to the log-rank test for differences between groups

Fig. 2.

Kaplan–Meier survival curves for patients with and without adalimumab use. The x-axis represents time in months, and the y-axis represents the probability of drug survival. Patients using adalimumab (“yes”) are compared with those not using adalimumab (“no”). The p value corresponds to the log-rank test for differences between groups

Contingency table analysis revealed that patients who received adalimumab were more likely to experience distribution problems than were those who received other biologics (49.35% versus 29%, p = 0.012). This can be explained by the increased frequency of administration required for adalimumab, which increases opportunities for logistical challenges. This structural relationship may account for the significant association observed in the unadjusted analyses of distribution problems; consequently, this association was attenuated after adjustment for adalimumab use.

Psoriasis relapse

A similar pattern was observed when the outcome of disease relapse was analyzed; disease relapse was, in fact, the most frequent cause of interruption of immunobiological therapy in patients undergoing treatment for psoriasis (Table 2). Both the occurrence of distribution problems (RR = 1.73; 95% CI: 1.24–2.42; p = 0.003) and the use of adalimumab compared with other biologics (RR = 1.48; 95% CI: 1.05–2.10; p = 0.037) were associated with increased risk of psoriasis relapse. A similar attenuation of the significance of the association between distribution problems and the use of adalimumab was observed in the adjusted model.

Table 2.

Analysis of the associations of the three principal risk factors for disease relapse using both unadjusted and adjusted analytical approaches

	Relapse
	Yes (n = 73)	No (n = 93)	RR (95% CI) p value	Log-rank p value	AFT–HR (95% CI) p value
Adalimumab use	41 (56.16%)	36 (38.71%)	1.48 (1.05–2.10) 0.037	0.030	1.62 (1.05–2.50) 0.030
Distribution problems	38 (52.05%)	26 (27.96%)	1.73 (1.24–2.42) 0.003	0.730	0.95 (0.62–1.46) 0.825
Poor adherence	9 (12.33%)	5 (5.38%)	1.53 (0.99–2.35) 0.187	0.150	1.52 (0.80–2.90) 0.201

n number of patients, RR  relative risk, 95% CI 95% confidence interval, AFT–HR hazard ratios estimated using an accelerated failure time (AFT) model

Adverse Events

Adverse events were infrequent, with only 15 patients discontinuing treatment because of serious adverse events; thus, adverse events played a minor role in drug survival. Among the patients who experienced serious adverse events, only one stopped treatment because of a MACE; this patient discontinued anti-TNF therapy after experiencing acute myocardial infarction (Supplementary Table S2 (Supplementary File S1)).

Discussion

Scientific advancements have provided highly effective and safe therapeutic options for individuals with psoriasis. While both controlled clinical trials and real-world studies have consistently demonstrated high drug survival rates in the treatment of psoriasis, the long-term effects of injectable biologics are often influenced by complexities associated with their administration [14]. Our findings indicate that distribution problems are significantly associated with an increased risk of treatment interruption and disease relapses. However, this association was reduced in the adjusted model, particularly among patients treated with adalimumab compared with those receiving other biologic therapies, primarily anti-interleukin agents. In this cohort, adalimumab users more frequently encountered distribution problems than patients who were on other treatments did (49% versus 29%), likely because of the higher dosing frequency required by adalimumab, which increases logistical complexity and the potential for supply interruptions. The results suggest that distribution problems may not act as independent risk factors but rather reflect the complexity of certain therapeutic regimens.

The genetic mechanisms of psoriasis are variable and not completely known but may, in some cases, influence specific treatment responses. Although some gene variants and epigenetic alterations have been associated with psoriasis, the exact influence of these on treatment response and treatment choice is uncertain [15, 16]. However, patients with psoriasis are exposed to a variety of genetic and environmental stimuli that trigger and maintain cutaneous and systemic inflammation [17]. Most of these factors are impossible to measure but they must always be considered when studying drug survival in psoriasis. However, the influence of distribution problems on treatment outcomes identified in this study appears to be a logical and important factor associated with therapeutic response.

Supply chain disruptions for biologic therapies extend beyond delivery delays. One such disruption may be cold-chain-storage disruption compromising product integrity and reducing efficacy. The resulting clinical impact also depends on drug-specific pharmacokinetic and pharmacodynamic profiles, as demonstrated in psoriasis management. Because psoriasis is predominantly driven by the T helper 17 pathway, anti-interleukin therapies targeting interleukin 17 or interleukin 23 provide more robust, sustained efficacy than adalimumab. Furthermore, adalimumab seems to have a higher propensity for inducing neutralizing anti-drug antibodies than anti-interleukin treatments [18]. When distribution failures cause treatment interruptions, the resulting depletion of circulating drug levels may lead to high immunogenicity, significantly accelerating therapeutic failure in patients maintained on adalimumab.

Other findings also highlight significant individual-level barriers to the use of injectable biologics. Notably, 34.33% of patients reported that their biologic medication was out of stock at some point during treatment. With respect to drug administration, 12.65% of patients experienced considerable discomfort associated with injectable medications, and 5.43% (nine patients) reported injection-related phobia. Application difficulties of this type are well documented in literature and can hinder the use of self-injected biologics, despite the fact that self-injection is a feature that generally enhances the convenience and cost-effectiveness of these therapies by reducing dependence on expensive infusion facilities [14, 19]. Most patients (87.35%) in our study cohort performed self-administration at home, although this did not directly impact drug survival. Postinjection management also raised concerns: 22.23% of patients reported disposing of biologic waste in the regular trash, indicating a lack of proper education of patients regarding safe disposal practices.

The most immediate solution to the distribution problem our study identified in one of Brazil’s major cities and that appears to negatively impact therapeutic outcomes is to implement more efficient management of the distribution process. However, this poses a significant challenge, especially given the increasing demand for these medications. In addition to internal issues, global shortages such as those experienced during the coronavirus disease 2019 (COVID-19) pandemic can occur [20]. Also, patients may benefit from adjunctive or temporary rescue therapies to mitigate clinical degradation during biologic supply chain interruptions. Topical agents offer an immediate, accessible therapeutic alternative; standard topical corticosteroids, while primary choices for mild disease, are frequently co-administered with systemic agents to control localized flares [21]. Furthermore, recently developed topical formulations with enhanced access profiles can serve as critical bridges during distribution failures, stabilizing disease activity and preventing systemic relapse until biologic supply chains are restored [22].

Although controlled trials have established an optimal therapeutic landscape for psoriasis, recent advancements in disease management highlight two primary areas of therapeutic innovation: agents that offer improved dosing regimens and the development of orally administered alternatives [23–31]. Current pipeline developments reveal that injectable therapies maintain a robust evolutionary trajectory in psoriasis management. The focus of research is on evaluating higher doses of established therapeutics and engineering novel molecules with extended half-lives and prolonged dosing regimens [32, 33]. By significantly extending the intervals between administrations, these advancements optimize dosing schedules and streamline the entire logistical framework. Oral therapies are already an integral component of psoriasis management. However, compared with injectable biologics, conventional agents such as methotrexate, cyclosporine, acitretin, fumaric acid esters, and apremilast generally exhibit lower therapeutic efficacy [34]. Deucravacitinib, a tyrosine kinase 2 (TYK2) inhibitor that was recently approved for use in several countries, and other options are currently being evaluated in clinical trials and in extension studies [27–31]. Zasocitinib is also an investigational TYK2 inhibitor that can be considered in the future for psoriasis treatment [31]. Icotrokinra is an oral, targeted cyclic peptide that selectively binds and blocks the interleukin-23 receptor that has been reported to deliver robust and durable skin clearance in moderate-to-severe plaque psoriasis [35–37]. Oral therapies offer several advantages over injectables, including lower cost because of the absence of specialized safety devices and cold-chain logistics, as well as simplified distribution and administration, two key benefits in large geographic regions [38].

Direct comparative studies are currently lacking, and the number of approved oral therapies for psoriasis remains limited. However, a prior network meta-analysis demonstrated that among nonbiologic systemic treatments, treatment with deucravacitinib resulted in the highest PASI 75 response rates at multiple time points. During long-term follow-up, the PASI 75 response rate for deucravacitinib was 65.9% (95% CI: 58.0–73.4); this response rate is comparable to that for first-generation biologics such as adalimumab (62.8%; 95% CI: 55.3–69.6) and ustekinumab (68.0%; 95% CI: 64.6–71.5) [39]. These data suggest that orally administered alternatives could be valuable for psoriasis treatment, given their safety, cost-effectiveness, and efficacy. Deucravacitinib may also help address adherence issues associated with adalimumab, potentially reducing the need for escalation to more expensive anti-interleukin therapies and thereby decreasing overall healthcare costs. Another advantage of oral therapies is that many patients prefer them over injectables; this can improve treatment adherence in certain cases [40]. This is especially important for children and for individuals who are unable to manage their medications without assistance [41].

The main limitation of this study is its observational design, which inherently precludes prospective randomization and introduces potential confounding factors. In addition, complex multivariable analyses may have been less than optimally effective because of the limited sample size. These issues could be addressed in the future using registry updates with larger cohorts and longer follow-up periods. Nevertheless, the associations between distribution problems and adalimumab use remain consistent and plausible, suggesting that drugs with less convenient dosing regimens, such as adalimumab, are more susceptible to the negative effects of distribution challenges.

Conclusions

In settings marked by significant stress within the distribution, storage, and administration chains for immunobiologics, distribution problems appear to negatively affect drug survival. Agents with optimized dosing schedules, permitting longer intervals between administrations, and improving the availability of oral alternatives may help mitigate difficulties commonly observed with adalimumab and negative distribution effects in Brazil.

Supplementary Information

Below is the link to the electronic supplementary material.

Author Contributions

Conceptualization: Samia Fares, Gabriel B F dos Santos, and Ciro Martins Gomes; Methodology: Samia Fares, Gabriel B F dos Santos, and Ciro Martins Gomes; Formal analysis and investigation: Luciana Alves Ribeiro, Patrícia Shu Kurizky, Rodrigo Ramos de Sena, Letícia Oba Galvão, Licia Maria Henrique da Mota, and Ciro Martins Gomes; Writing–original draft: Ciro Martins Gomes; Writing–review and editing: Samia Fares, Gabriel B F dos Santos, and Ciro Martins Gomes; Funding acquisition: Samia Fares, Gabriel B F dos Santos, and Ciro Martins Gomes; Resources: Luciana Alves Ribeiro, Patrícia Shu Kurizky, Letícia Oba Galvão, and Ciro Martins Gomes; Supervision: Samia Fares, Gabriel B F dos Santos, and Ciro Martins Gomes.

Funding

This research was funded by Bristol Myers Squibb. Funding for the rapid service fee was also provided by Bristol Myers Squibb.

Data Availability

All data generated or analyzed during this study are included in this published article (and its supplementary information files). (Supplementary File S2).

Declarations

Conflicts of Interest

Dr. Luciana Alves Ribeiro does not have conflicts of interest to disclose. Dr. Patrícia Shu Kurizky is a consultant, lecturer, and/or researcher for Boehringer-Ingelheim, Johnson & Johnson, UCB, and Novartis. Mr. Rodrigo Ramos de Sena is a consultant for the Brazilian Ministry of Health. Samia Fares and Gabriel B F dos Santos are employees of Bristol Myers Squibb. Dr. Letícia Oba Galvão is a consultant, lecturer, and/or researcher for Johnson & Johnson, UCB, Novartis, and AbbVie. Professor Licia Maria Henruique da Mota has received personal or institutional support from AbbVie, Janssen, Pfizer, and Roche; has delivered speeches at events related to this work; and is sponsored by AbbVie, Boehringer-Ingelheim, GSK, Janssen, Libbs, Lilly, Novartis, Pfizer, Roche, Sandoz, and UCB. Prof. Ciro Martins Gomes is a consultant, lecturer, and/or researcher for Boehringer-Ingelheim, Johnson & Johnson, UCB, Eli Lilly and Company, Bristol Myers Squibb, Novartis, and AbbVie.

Ethical Approval

The data used in this study were obtained from a longitudinal registry entitled “Autoimmune Diseases in Real Life in Brazil: A Multicenter Cohort Study Based on the Evaluation of Clinical and Molecular Epidemiology"; registry no./approval no. CAAE: 68,068,323.3.1001.5558. The registry received approval from the Research Ethics Committee of the Faculty of Medicine of the University of Brasília, Brazil. All patients signed informed consent forms.