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Assessment of the treat-to-target strategy in patients with refractory rheumatoid arthritis

A prospective study on efficacy and safety in a Saudi population

Untersuchung der zielgenauen Behandlungsstrategie bei Patienten mit therapierefraktärer rheumatoider Arthritis

Eine prospektive Studie zur Wirksamkeit und Sicherheit in einer saudischen Population

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Abstract

Aim

The goal of the present study was to prospectively assess the long-term clinical outcome of biologic modifying drug therapy in a population of Saudi rheumatoid arthritis (RA) patients.

Patients and methods

This is the first prospective, long-term report on the efficacy and safety of biologic therapy in Saudi RA patients. It is a single center, observational study with a follow-up period of 3 years. Enrolled were 120 biologic naïve patients (94 women, 78.3 %; mean age 48.4 ± 17.9 years, mean disease duration 7.3 ± 3.9 years) with the diagnosis of RA (ACR/EULAR, 2010 criteria) who were inadequate responders to methotrexate and synthetic DMARDs.

Results

After 3 years, the mean Disease Activity Index-28 (DAS-28), Health Assessment Questionnaire (HAQ), Pain Score, ESR, and CRP values improved significantly. Of the 99 patients completing the 3-year follow-up, 35.3 % of patients achieved DAS-28 remission and 53.5 % achieved low disease activity, and 11.1 % of patients had moderate to high activity scores. At the 3-year follow-up, 80 % of patients had no evidence of significant radiographic progression (achieved < 0.5 of the mean total Sharp score). Infections were reported in 11.7 % and significantly correlated with conjugate use of oral prednisolone at doses above 5 mg/day, with chest infections being the most common type of infection (6.7 %).

Conclusion

The results of this study can be understood as real-life clinical experience displaying the incremental benefit of biologic therapy in refractory disease when it is added to other optimal strategies. The study showed satisfying clinical and functional benefit with considerable safety.

Zusammenfassung

Ziel

Ziel der vorliegenden Studie war die prospektive Untersuchung des klinischen Langzeitverlaufs unter biologischer krankheitsmodifizierender medikamentöser Therapie in einer Population von saudischen Patienten mit rheumatoider Arthritis (RA).

Patienten und Methoden

Dies ist die erste prospektive Langzeitstudie zur Wirksamkeit und Sicherheit der biologischen Therapie bei saudischen RA-Patienten. Es handelt sich um eine Einzelzentrum-Beobachtungsstudie über 3 Jahre. In die Studie eingeschlossen wurden 120 Biologika-naive Patienten (94 Frauen, 78,3 %; Durchschnittsalter: 48,4 ± 17,9 Jahre, durchschnittliche Krankheitsdauer: 7,3 ± 3,9 Jahre) mit der Diagnose einer RA (ACR/EULAR-Kriterien von 2010), die nicht ausreichend auf Methotrexat und synthetische DMARD ansprachen.

Ergebnisse

Nach 3 Jahren besserten sich die Durchschnittswerte für den Disease Activity Score 28 (DAS-28), Health Assessment Questionnaire, Schmerzscore, BSG und CRP deutlich. Beim DAS-28 erzielten von den 99 Patienten mit vollständiger 3-jähriger Nachbeobachtung 35,3 % eine Remission, 53,5 % eine niedrige Krankheitsaktivität und 11,1 % einen mittleren bis hohen Wert. Nach 3 Jahren Follow-up bestand bei 80 % der Patienten kein Hinweis auf eine wesentliche röntgenologische Progression (< 0,5 des durchschnittlichen Sharp-Gesamtscores). Infektionen wurden in 11,7 % der Fälle dokumentiert, sie waren signifikant mit der kombinierten Gabe von Prednisolon p.o. in Dosen über 5 mg/ korreliert, am häufigsten (6,7 %) waren Thoraxinfektionen.

Schlussfolgerung

Die Ergebnisse der vorliegenden Studie können als praktische klinische Erfahrung angesehen werden, welche den zunehmenden Nutzen der biologischen Therapie bei therapierefraktärer Erkrankung zeigt, wenn sie optimal mit anderen Strategien zusammen eingesetzt wird; die Studie ergab einen befriedigenden klinischen und funktionellen Nutzen bei beträchtlicher Sicherheit.

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Acknowledgment

The authors would like to acknowledge the great effort and contribution of Professor Dr. Yusuf Yazici (Associate Professor of Rheumatology, NYU) in reviewing the scientific and statistical contents of this research.

Compliance with ethical guidelines

Conflict of interest. R.H.A. Mohammed, H.H. Kewan, and M. Bukhari state that there are no conflicts of interest.

All studies on humans described in the present manuscript were carried out with the approval of the responsible ethics committee and in accordance with national law and the Helsinki Declaration of 1975 (in its current, revised form). Informed consent was obtained from all patients included in studies.

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Authors and Affiliations

  1. Rheumatology and Rehabilitation, School of Medicine, Cairo University Hospitals, Cairo, Egypt

    R.H.A. Mohammed MD, PhD

  2. Rheumatology section, Internal Medicine Department, Alhada Armed Forces Hospital, Alhada, Kingdom of Saudi Arabia

    R.H.A. Mohammed MD, PhD

  3. Department of Radio-diagnosis, Faculty of Medicine, Mansoura University, Mansoura, Egypt

    H.H. Kewan

  4. Internal Medicine Department, Alhada Armed Forces Hospital, Taif, Kingdom of Saudi Arabia

    M. Bukhari MB. Bch

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  1. R.H.A. Mohammed MD, PhD
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Correspondence to R.H.A. Mohammed MD, PhD.

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Mohammed, R., Kewan, H. & Bukhari, M. Assessment of the treat-to-target strategy in patients with refractory rheumatoid arthritis. Z. Rheumatol. 73, 746–753 (2014). https://doi.org/10.1007/s00393-013-1335-2

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