Evidence map›Paper›PMID 36813476›Full record

ArticleRMD open2023

Real-life efficacy and safety of nintedanib in systemic sclerosis-interstitial lung disease: data from an Italian multicentre study.

Corrado Campochiaro, Giacomo De Luca, Maria-Grazia Lazzaroni, Giuseppe Armentaro, Amelia Spinella, Barbara Vigone, Barbara Ruaro, Anna Stanziola, Devis Benfaremo, Enrico De Lorenzis and 12 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in RMD open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
6.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 12 institutions in 1 country.

Corrado CampochiaroUnit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS Ospedale San Raffaele, Milan, Italy campochiaro.corrado@hsr.it.ORCID 0000-0001-6806-3794
Giacomo De LucaUnit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS Ospedale San Raffaele, Milan, Italy.ORCID 0000-0002-5306-7714
Maria-Grazia LazzaroniRheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy.
Giuseppe ArmentaroScleroderma Clinic, Gaetano Pini-CTO, Milan, Italy.
Amelia SpinellaRheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy.
Barbara VigoneScleroderma Clinic, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Barbara RuaroUnit of Respiratory Medicine, Ospedale di Cattinara, Trieste, Italy.
Anna StanziolaUnit of Respiratory Medicine, Federico II University Hospital, Naples, Italy.
Devis BenfaremoClinica Medica, Polytechnic University of Marche, Ancona, Italy.
Enrico De LorenzisRheumatology, Catholic University of the Sacred Heart Faculty of Medicine and Surgery, Rome, Italy.ORCID 0000-0001-9819-105X
Beatrice MoccaldiRheumatology, Università degli Studi di Padova, Padova, Italy.
Silvia Laura BoselloRheumatology, Catholic University of the Sacred Heart Faculty of Medicine and Surgery, Rome, Italy.
Giovanna CuomoPrecision Medicine, Universita degli Studi della Campania Luigi Vanvitelli, Caserta, Italy.
Lorenzo BerettaScleroderma Clinic, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID 0000-0002-6529-6258
Elisabetta ZanattaRheumatology, Università degli Studi di Padova, Padova, Italy.
Dilia GiuggioliRheumatology, University of Modena and Reggio Emilia, Modena, Italy.
Nicoletta Del PapaScleroderma Clinic, Gaetano Pini-CTO, Milan, Italy.ORCID 0000-0003-1549-8852
Paolo AiroRheumatology and Clinical Immunology, Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy.
Marco ConfalonieriUnit of Respiratory Medicine, Ospedale di Cattinara, Trieste, Italy.
Gianluca MoronciniClinica Medica, Polytechnic University of Marche, Ancona, Italy.
Lorenzo DagnaUnit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS Ospedale San Raffaele, Milan, Italy.ORCID 0000-0002-7428-315X
Marco Matucci-CerinicUnit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS Ospedale San Raffaele, Milan, Italy.ORCID 0000-0002-9324-3161
Vita-Salute San Raffaele University · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITIstituto Ortopedico Gaetano Pini · ITMarche Polytechnic University · ITOspedale di Cattinara · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Modena and Reggio Emilia · ITUniversity of Padua · ITFederico II University Hospital · ITIRCCS Ospedale San Raffaele · ITUniversity of Campania "Luigi Vanvitelli" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNintedanib (NTD) has been shown to be effective in systemic sclerosis (SSc)-interstitial lung disease (ILD). Here we describe the efficacy and safety of NTD in a real-life setting.

methodsPatients with SSc-ILD treated with NTD were retrospectively evaluated at 12 months prior to NTD introduction; at baseline and at 12 months after NTD introduction. The following parameters were recorded: SSc clinical features, NTD tolerability, pulmonary function tests and modified Rodnan skin score (mRSS).

results90 patients with SSc-ILD (65% female, mean age 57.6±13.4 years, mean disease duration 8.8±7.6 years) were identified. The majority were positive for anti-topoisomerase I (75%) and 77 (85%) patients were on immunosuppressants. A significant decline in %predicted forced vital capacity (%pFVC) in the 12 months prior to NTD introduction was observed in 60%. At 12 months after NTD introduction, follow-up data were available for 40 (44%) patients and they showed a stabilisation in %pFVC (64±14 to 62±19, p=0.416). The percentage of patients with significant lung progression at 12 months was significantly lower compared with the previous 12 months (60% vs 17.5%, p=0.007). No significant mRSS change was observed. Gastrointestinal (GI) side effects were recorded in 35 (39%) patients. After a mean time of 3.6±3.1 months, NTD was maintained after dose adjustment in 23 (25%) patients. In nine (10%) patients, NTD was stopped after a median time of 4.5 (1-6) months. During the follow-up, four patients died.

conclusionsIn a real-life clinical scenario, NTD, in combination with immunosuppressants, may stabilise lung function. GI side effects are frequent and NTD dose adjustment may be necessary to retain the drug in patients with SSc-ILD.

Indexed as

Lung Diseases, InterstitialScleroderma, SystemicAdultAgedFemaleHumansImmunosuppressive AgentsIndolesMaleMiddle AgedRetrospective StudiesImmunosuppressive AgentsIndolesnintedanibbiological therapypulmonary fibrosisscleroderma, systemictherapeutics

Identifiers

PMID36813476
PMCPMC9950968
OpenAlexW4321503853

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.